Docstoc

Medical Device

Document Sample
Medical Device Powered By Docstoc
					www.complianceonline.com                                Online
                                                Compliance
                                                The Most Comprehensive Resource for Compliance & Quality




 Compliance Training for
 Medical Device Companies
 Last Updated Jan, 2010




  ComplianceOnline:Medical Device Training
  Medical device manufactures require robust business processes to ensure regulatory obligations and qual-
  ity requirements are being met. Regulatory requirements include FDA GXPs, reporting mandates, interna-
  tional device safety standards, marketing laws and various compliance requirements. ComplianceOnline.com
  uniquely provides training and content for effective and sustainable compliance based on best practices
  from an highly experienced expert community and regulators.


  About the Training Programs:
  These trainings are created by expert trainers and compliance specialists from around the world and customized
  to different rules and regulations. These courses are recordings of previous WebSeminars which were conducted
  as live sessions with synched audio and presentation, including Q&A.

  All of these courses include presentations, sound and other animations. These courses are Available as Live
  webinar or On Demand recordings. For companies want to train large number employees through existing LMS,
  these courses can be converted to SCORM compliant content and delivered by ComplianceOnline.

  Live:        Attendees viewing the Live webinar can ask questions to expert during the webinar.
  Recorded: Attendees viewing the recording can ask Questions to experts using the feature
               https://www.complianceonline.com/ecommerce/control/answersHome
  CD:          These courses are also available as CDs. Up on purchase you will receive the CD within
               15 business days.The CD pack contains the presentation material, the course file and any
               additional material. One CD can be used in one site.




                                                                                            © Copyright, ComplianceOnline
          www.complianceonline.com | 2600 E. Bayshore Road Palo Alto, CA 94303 | Ph: 650-620-3937 | Fax: +1-650-963-2556
C omplianceO nline: Medical D evice T raining                                                                                                       Online
                                                                                                                                            Compliance
                                                                                                                                             The Most Comprehensive Resource for Compliance & Quality



T ABLE          OF      C ONTENTS:

FDA Guidelines ................................................................................................................................................................................1
System Based Inspection..........................................................................................................................................................................2
FDA Validation .................................................................................................................................................................................2
Auditing....................................................................................................................................................................................................3
Documentation...................................................................................................................................................................................4
Electronic Records and 21 CFR Part 11.............................................................................................................................................4
GMP / CGMP..................................................................................................................................................................................................5
Sterilization ....................................................................................................................................................................................5
Design Control....................................................................................................................................................................................................6
Submission, Approval........................................................................................................................................................................................6
CAPA ....................................................................................................................................................................................................7
FDA Inspection.....................................................................................................................................................................................8
FMEA..........................................................................................................................................................................................8
Recall..........................................................................................................................................................................................................9
HR Related.........................................................................................................................................................................................................9
Role Related........................................................................................................................................................................................................10
EU / Latin America Regulations........................................................................................................................................................10
Japan Regulations...............................................................................................................................................................................11
Quality System..............................................................................................................................................................................................11
Clinical Compliance...............................................................................................................................................................................................................12
Laboratory Compliance ....................................................................................................................................................................13
Water System Compliance..................................................................................................................................................................................14
OSS .................................................................................................................................................................................. 14
Marketing / Sales..................................................................................................................................................................................14
Packaging & Labeling...............................................................................................................................................................................15
Risk Management ..............................................................................................................................................................................16
Cleaning Validation...............................................................................................................................................................................17
Combination products............................................................................................................................................................................................17
IT and Software........................................................................................................................................................................................................18
ISO Standards... ...........................................................................................................................................................................18
Microbial Compliance................................................................................................................................................................................................19
Facility Design.........................................................................................................................................................................................20
Vendor/Supplier/CRO Compliance ..............................................................................................................................................20


                                                                                                                                                                                © Copyright, ComplianceOnline
                       www.complianceonline.com | 2600 E. Bayshore Road Palo Alto, CA 94303 | Ph: 650-620-3937 | Fax: +1-650-963-2556
Compliance O nline: M edical D evice T raining                                                     Online
                                                                                           Compliance
                                                                                           The Most Comprehensive Resource for Compliance & Quality



    Compliance Course Catalogue
    How to use this catalogue for course description.
    To register please click on the topic name and visite our website at www.complianceonline.com
    you can also create a customized course catalogue by visiting our training search page at
    http://www.complianceonline.com/ecommerce/control/compliance-training-search


!    FDA Guidelines
Course ID           Course Name

700863              U. S. FDA Medical Device Approval Process
700959              The FDA’s proposed Medical Device Data System (MDDS) rule and its implications for currently regulated and unregulated
                    vendors and providers
701109              Off-Label Promotion of Medical Devices: Maximizing Your Performance Claims within FDA’s Framework of Acceptable
                    Practices
700148              The Revision of the Medical Devices Directive 93/42/EEC, Background, Proposal and What It Means
701141              FDA's Update on Medical Device Labeling Changes
701342              FDA and ISO mandates for Old and New Medical Devices Products and Surgical Instruments
701175              Design History Files and Technical Files under US FDA and EU MDD
701140              New Medical Device Vigilance Guidelines
700253              Essential Regulatory Strategies for Medical Devices on the "Class II / III Cusp"
700708              ISO 14971:2007 -- The Newly Revised Risk Management Standard for Medical Products
701158              Combination products and convergence: an overview of clinical benefits, regulatory issues and manufacturing challenges
                    - part 1
701160              Combination products and convergence: an overview of clinical benefits, regulatory issues and manufacturing challenges
                    - part 2
701073              Changes to the Medical Devices Directive: 93/42/EEC
701143              FDA Requirements for Device Labeling: Development, Contents, Distribution, and Changes
701361              Understanding the new NAIC (National Association of Insurance Commissioners) Model Regulation
701446              Current Medical Device Regulatory Issues
701312              GHTF (Global Harmonization Task Force) is changing the global medical device industry; will it help you or hurt you?
700861              Human Factors Standards and Guidance’s for Medical Devices -- which documents apply to my situation?
700842              Understanding the recent FDA Gudiance on Computerized Systems Used in Clinical Investigations
700216              Tort Law and Strict Liability for FDA Regulated products-What every Regulatory Affairs and Quality Professionals should
                    know
700645              The FDA's Outlook for Quality in Device Manufacturing
700921              The Essentials of Food and Drug Administration Medical Device Regulations: A Primer for Manufacturers and Suppliers;
                    Part 1- Quality System Regulation
700922              The Essentials of Food and Drug Administration Medical Device Regulations:A Primer for Manufacturers and Suppliers -
                    Registration, Medical Device Reporting, Corrections and Removals (Recalls)
                                                                                                                                     Back to Top




                                                                                                                 © Copyright, ComplianceOnline
01             www.complianceonline.com | 2600 E. Bayshore Road Palo Alto, CA 94303 | Ph: 650-620-3937 | Fax: +1-650-963-2556
C omplianceO nline: M edical D evice T raining                                                Online
                                                                                      Compliance
                                                                                      The Most Comprehensive Resource for Compliance & Quality




701341          The Proposed Recast of the Medical Devices Legislation
701242          Validation and Use of Excel® Spreadsheets in Regulated Environments
701537          Presenting Risk Information in Drug and Medical Device Promotion: FDA's Update on Draft Guidance for Industry




!   System Based Inspection
Course ID       Course Name

701332          Understanding and Preparing for System Based Inspections: Facilities and Equipment System
701333          Understanding and Preparing for System Based Inspections: Materials System
701335          Understanding and Preparing for System Based Inspections: Packaging and Labeling System
701334          Understanding and Preparing for System Based Inspections: Production System
701331          Understanding and Preparing for System Based Inspections: The Quality System
701336          Understanding and Preparing for System Based Inspections: Laboratory Control System




!   FDA Validation
Course ID       Course Name

700249          Requirements engineering - the keystone to successful validation of your medical device
700245          Reprocessing Reusable Medical Devices - Cleaning & Labeling Requirements - validations
701099          Basics of Writing Validation Protocols for Medical Devices
701123          Practical Process Validation Part 1 - Validation Planning, Prerequisites and Best Practices
701124          Practical Process Validation Part 2 - Qualification Steps, Process Controls and Sustainability Strategies
701257          Process Validation for Medical Device Manufacturers
700342          Introduction to Process Capability (Cp, CpK, Pp, Ppk)
700242          Validation and Use of Excel® Spreadsheets in Regulated Environments
700158          Validation of Analytical Methods and Procedures - Design, Conduct and Document for Efficiency and Compliance
700212          Validation of Computerized Analytical Systems
700456          Verification of Compendia Methods Understanding the New USP Chapter <1226>
700445          Verification vs Validation
700828          Verification vs. Validation in Regulated Industries
700910          Develop, Execute and Enforce an Effective Validation Master Plan
701363          Risk-Based Validation of cGMP Systems
701297          Process Validation Principles and Protocols
701326          The 6 Most Common Problems in FDA Software Validation & Verification
700625          Efficient Computer System Validation - 10 Easy Steps

                                                                                                                                Back to Top



                                                                                                              © Copyright, ComplianceOnline
02          www.complianceonline.com | 2600 E. Bayshore Road Palo Alto, CA 94303 | Ph: 650-620-3937 | Fax: +1-650-963-2556
C ompliance Online: M edical Device T raining                                                  Online
                                                                                       Compliance
                                                                                       The Most Comprehensive Resource for Compliance & Quality




701113          FDA requirements for the Validation of Computer Systems
701069          GxP Computer Systems Validation: The Investigator’s Point of View
700357          How to Use the System Risk Level to Save Time and Money on Computer System Validations
700106          Master Planning for Computer System Validation
700339          The Five Keys to COTS Computer System Validation
700627          Vendor Qualification Auditing for FDA Computer System Compliance
701121          Webinar - Computer Systems Used In Clinical Trials
701188          Maintenance and Calibration of Equipment
700149          Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements
700888          How To Build Quality Into Commissioning And Validation
701084          Gage R & R - Improving the Reliability and Reducing the Variation of Your Measurement System
700412          HPLC Method Development and Validation
701297          Process Validation Principles and Protocols
701470          How to reduce software validation project time and use risk management to improve system performance
701489          Excel Spreadsheet Validation To Eliminate 483s
701110          Important requirements when validating sterilizing grade filters
701552          Fundamentals of Process Validation
701520          FDA Warning Letter - Consent Decree Software Validation



!   Auditing
Course ID      Course Name
700135         Internal Auditing Essentials for Medical Device Manufacturers to comply with FDA QSR and ISO13485
700847         4-Region internal audits: Medical Device Quality System audits that cover internal regulatory compliance for FDA, Europe,
               Canada and Japan
701310         Preparing and Executing Medical Device Quality Audits: How to Meet the FDA’s Expectations
701014         Internal Audits and Supplier/Subcontractor Audits
701287         Development and Audit of Complaint Handling and MDR Processes
700427         Implementing a Risk-Based Internal CGMP Annual Audit Program
700816         Preparing for a U.S. FDA Audit
700385         Methods for Including Your Risk Management Process In Your Internal Auditing Process
700260         Auditing a Process-based System
700898         IQ/OQ/PQ, a vital link in the quality chain for both FDA and Client audits
700962         Conducting Process Audits within both ISO 9001 and ISO 13485
701325         Auditing Analytical Laboratories for FDA Compliance
701364         Auditing the QC Microbiology Laboratory for FDA Compliance
701432         U.S. FDA cGMP Compliance Audits -- Raising the Bar
701540         The Odds are Against Auditing: Statistical Sampling in Audits
701555         Auditing Clinical Trials for GCP Compliance
                                                                                                                                Back to Top


                                                                                                             © Copyright, ComplianceOnline
03          www.complianceonline.com | 2600 E. Bayshore Road Palo Alto, CA 94303 | Ph: 650-620-3937 | Fax: +1-650-963-2556
Compliance O nline: M edical D evice T raining                                                   Online
                                                                                         Compliance
                                                                                         The Most Comprehensive Resource for Compliance & Quality




!   Documentation
Course ID      Course Name
700375          Best Practices for Writing an Effective SOP to Lead to Successful FDA Inspections
701330          Basics of testing associated with sterilization validation and routine processing
701020          Effective Records, Document Control, and SOPs
700179          Making cGMP Documentation Practical
701057          What are DHF, DMR and DHR? - The FDA Quality Systems Regulations Documents Explained
700896          Risk Assessment-Compliance Using Easy To Fill Out Documentation
700127          Introduction to Good Documentation Practices for FDA-Regulated Industries
700152          Introduction to Styles in Microsoft Word for FDA Regulated Industries
700126          Reducing the Cost of Creating Documents for FDA-Regulated Industries
700235          The common technical dossier – guidance on writing the overviews and summaries
700254          Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements in a Relatively
                Paper-Free Manner
701320          Good Documentation Practices for GXPs
701407          Avoid Documentation 'Time Bombs'
701327          Validation and use of Excel spreadsheets in FDA regulated environments
701386          How to Write an ICH-Compliant Clinical Study Report
701348          The Secret of Study Conduct Documentation to ensure a successful Audit: What the FDA Inspectors looks for
701271          Excel Spreadsheets and FDA Device Regulations
701455          A Unified Approach to Complaints, Servicing, and FDA Reporting
701467          Guide to Writing and Maintaining Standard Operating Procedures (SOPs)



!   Electronic Records and 21 CFR Part 11
Course ID      Course Name
701217          21 CFR Part 11 compliance for Electronic Medical Records
700211          21 CFR Part 820 and ISO 13485:2003 - Best Practices in Quality Management System Basics
700616          Cost Reduction for 21 CFR Part 11
701344          How does 21 CFR Part 11 help ensure data integrity and subject safety in clinical research
700942          Impact of 21 CFR Part 11 on Information Systems
701216          Software validation and 21 CFR Part 11 remediation planning: FDA inspection strategies
700664          The latest approach for complying with 21 CFR Part 11
701328          21CFR Part 11 - Predicate Rules Compliance
700970          21CFR Part 11 Compliance: Preparing for Successful Regulatory Inspection
700719          Preparing Compliant eCTD Submissions
700992          Organization of Clinical Datasets in eCTD Submissions
700619          Part 11 – Electronic Records and Electronic Signatures
                                                                                                                                   Back to Top

                                                                                                               © Copyright, ComplianceOnline
04          www.complianceonline.com | 2600 E. Bayshore Road Palo Alto, CA 94303 | Ph: 650-620-3937 | Fax: +1-650-963-2556
C omplianceO nline: Medical D evice T raining                                                 Online
                                                                                      Compliance
                                                                                      The Most Comprehensive Resource for Compliance & Quality




701470          How to reduce software validation project time and use risk management to improve system performance
701518          FDA 21 CFR Part 11 for techies
701519          FDA Software Validation Self-Check – plan an effective Internal Audit program
701520          FDA Warning Letter - Consent Decree Software Validation



!   GMP / CGMP
Course ID      Course Name
700844         International GMP's for Medical Devices: Quality System requirements for USA, Europe, Canada and Japan
701363         Risk-Based Validation of cGMP Systems
700427         Implementing a Risk-Based Internal CGMP Annual Audit Program
701136         Effective Annual U.S. FDA CGMP Training
700179         Making cGMP Documentation Practical
700990         How to Prepare for FDA GMP Inspections
701026         PASSING A US FDA GMP INSPECTION: A–Z Guaranteeing a Pass the First Time through an FDA Inspection
700156         FDA's cGMPs for the 21st Century Initiative
701320         Good Documentation Practices for GXPs
701432         U.S. FDA cGMP Compliance Audits -- Raising the Bar
701491         Conduct of the Tougher U.S. FDA cGMP Inspection



!   Sterilization
Course ID      Course Name
700295         Basic Requirements for Steam Sterilizer Validation per ISO 17665
701330         Basics of testing associated with sterilization validation and routine processing
701272         Ethylene Oxide (EO) Sterilization Basics for R&D Engineers
700353         Ethylene Oxide Sterilizer Validation: Basic Requirements
701111         Introduction and Up-date to Relevant Guidance of Sterilizing
700180         Process Validation and Process Controls: Radiation Sterilization
700174         Review of Changes to the New ANSI/AAMI/ISO 11137-2006 (Parts 1, 2, & 3) Sterilization of health care
               products - requirements for validation and routine control - Radiation Sterilization
701110         Sterilizing Grade Filter Validation - Points to Consider
700119         Radiation Dose Setting - Method 1
700120         Radiation Dose Setting - Method 2
700227         Radiation Dose Setting - Method Vdmax
700991         Principles of Sterile Manufacturing
701452         How to implement parametric release in EO sterilization-Practical approach
701503         You have a sterility or Bioburden test failure - Now what?
                                                                                                                                Back to Top

                                                                                                             © Copyright, ComplianceOnline
05          www.complianceonline.com | 2600 E. Bayshore Road Palo Alto, CA 94303 | Ph: 650-620-3937 | Fax: +1-650-963-2556
C omplianceO nline: M edical D evice T raining                                                Online
                                                                                      Compliance
                                                                                      The Most Comprehensive Resource for Compliance & Quality




!   Design Control
Course ID      Course Name

700536         Design Controls Basics - From Design Inputs to Design Outputs and Effective Design Transfer
701230         Bringing Compliance to Design Control through Life Cycle Management of Older Medical Devices and Surgical
               Instruments
701285         Understanding Design Controls for Medical Devices
700159         What will FDA expect and request from your firm during Design Control portions of Inspections?
700223         Design Input: How to write requirements and modularize a product
701378         Design Control and Product Validation (Design Validation)
701360         Design Control for Professionals
701460         Design Control for Compliance and Fast Cycle Development
700392         Critical Parameters and Design, Process and Purchasing Controls
700526         Risk Management Activities during Design Input
700190         Development Planning: How to Structure, Write, and Effectively use Design and Development Plans
700344         Introduction to statistical Design and Analysis of Experiments (DOE)
700496         Doing Business under the North American Free Trade AgreementUnderstanding NAFTA




!   Submission, Approval
Course ID      Course Name

700784         510(k) Preparation for a Small to Medium-Sized Company
701016         The 510(k) Submission: Requirements, Contents, and Options
700815         Successful 510(k) Submissions
701374         Avoid 'Bet the Company' Decisions with Product Changes and 510(k)s
700908         Managing the IDE (Investigational Device Exemption) Submission for Compliance Success
701087         The IDE (Investigational Device Exemption) - It's Purpose and Preparation
700981         How to Prepare and Submit a Bullet Proof 510(k) Submission
700992         Organization of Clinical Datasets in eCTD Submissions
700956         IDE (Investigational Device Exemption) for PMA and 510(k) for CDRH and CBER
701497         The 510(k) Process and Risk Management
701315         Comparability Protocols (CPs): How and when to use them for POST APPROVAL CHANGES
                                                                                                                               Back to Top




                                                                                                            © Copyright, ComplianceOnline
06          www.complianceonline.com | 2600 E. Bayshore Road Palo Alto, CA 94303 | Ph: 650-620-3937 | Fax: +1-650-963-2556
C ompliance Online: Medical Device T raining                                               Online
                                                                                   Compliance
                                                                                   The Most Comprehensive Resource for Compliance & Quality




!   CAPA
Course ID      Course Name

701314         How CAPA and complaint handling should interact in Medical Device - Simplification of the processes is often
               needed to preserve their effectiveness
700850         Strategies for an Effective Root Cause Analysis and CAPA Program
700851         How FDA trains its investigators to review CAPA (FDA compliance program guidance manuals, QSIT manual) and
               what should you do to prepare
700393         Risk-Based CAPA Systems
700813         Hazard Analysis & Risk Management - New 14971
701085         How to Avoid an FDA Warning Letter with a Strong CAPA Program
700137         CAPA - Best Practices and Common Pitfalls for FDA Regulated Industries
700299         CAPA Essentials - core principles and practices needed to implement an effective and efficient CAPA process
700377         From CAPA to Capability: Shifting the Focus to Profitability
700818         Bullet-Proof CAPA CAPA
700141         Root Cause Analysis for Corrective and Preventive Action (CAPA)
700525         Integrating Risk Management with the CAPA process
700550         Developing a Robust CAPA System
700322         Elements of a CAPA program and uses of CAPA data
700746         Maintaining an Effective CAPA Program and Using Risk Assessment Tools: Current Trends
700451         CAPA systems in Post Marketing Surveillance
700914         The CAPA Trap or Common Problems and Pitfalls
700912         Tracking Use Error Risks in Post-Market Surveillance and CAPA Activities
700966         Root Cause Analysis for CAPA Management (Shutting Down the Alligator Farm)
700943         CAPA Management and Compliance with Regulatory Requirements
700997         CAPA – Root cause and risk management
701025         EFFECTIVE INVESTIGATIONS AND CORRECTIVE ACTIONS (CAPA) Establishing and resolving the root causes of
               deviations, problems and failures
701152         'Preventive Action' - the often ignored side of CAPA: Use FMEA to build preventive action into your CAPA program
700130         Setting up a QSR Compliant CAPA System
701373         Root Cause Analysis - Starting at the Beginning
701389         Avoid the common confusion surrounding Corrections and CAPA
701433         Advanced CAPA (Corrective and Preventive Action)
701426         CAPA for Your Work life and Beyond: Effective CAPA techniques and organizational skills you must know before
               solving any problem
701498         Integrating Risk Management into the CAPA System
                                                                                                                              Back to Top




                                                                                                         © Copyright, ComplianceOnline
07          www.complianceonline.com | 2600 E. Bayshore Road Palo Alto, CA 94303 | Ph: 650-620-3937 | Fax: +1-650-963-2556
C ompliance Online: Medical D evice T raining                                             Online
                                                                                  Compliance
                                                                                  The Most Comprehensive Resource for Compliance & Quality




!   FDA Inspection
Course ID       Course Name
700788         Quality Systems Inspection Technique (QSIT), and How to use it to Your Advantage
700987         What to Expect During an FDA Inspection, and How to Handle It
701410         Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations
701482         Win-Win FDA Inspections
701236         How to Prepare for, Manage, and Follow-up to an FDA Inspection
701025         EFFECTIVE INVESTIGATIONS AND CORRECTIVE ACTIONS (CAPA) Establishing and resolving the root causes of
               deviations, problems and failures
701038         Documenting & Conducting CAPA Investigations
701085         How to Avoid an FDA Warning Letter with a Strong CAPA Program
700375         Best Practices for Writing an Effective SOP to Lead to Successful FDA Inspections
701090         FDA at the Door: Ten Essential Steps for Inspection Success
700513         FDA Compliance and Quality inspections
700163         FDA Inspections-Dos & Don'ts
700298         How to Manage an FDA Inspection
700646         How To Prepare for an FDA Inspection - A Practical Prospective
700990         How to Prepare for FDA GMP Inspections
700892         How to prepare for the unannounced FDA compliance inspection
701026         PASSING A US FDA GMP INSPECTION: A–Z Guaranteeing a Pass the First Time through an FDA Inspection
700250         Preparing for an FDA Inspection
701324         Preparing for an FDA Inspections & FDA Inspection Dos & Don'ts
700744         Surviving an FDA Inspection: Understand the Do's and Don'ts and the Ground Rules
700269         The FDA Inspection Process: From SOP to 483
700159         What will FDA expect and request from your firm during Design Control portions of Inspections?
700909         Conducting Successful Product Complaint Investigations
701491         Conduct of the Tougher U.S. FDA cGMP Inspection
701498         Integrating Risk Management into the CAPA System
701204         EFFECTIVE INVESTIGATIONS What to Do When the Unexpected Happens! - Proper Investigation of Quality Events
701492         21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection



!   FMEA
Course ID      Course Name
700109         Risk Management for Medical Devices: Best Practices to Make Your FMEA Process Work For You
700621         The Use and Mis-use of FMEA in Medical Device Risk Management
700329         Effectively application of FMEA as a Risk Management Tool and meet ISO 13485:2003 Risk Management
               (ISO 14971) Requirements
                                                                                                                            Back to Top

                                                                                                        © Copyright, ComplianceOnline
08          www.complianceonline.com | 2600 E. Bayshore Road Palo Alto, CA 94303 | Ph: 650-620-3937 | Fax: +1-650-963-2556
C omplianceO nline: M edical D evice Training                                               Online
                                                                                    Compliance
                                                                                     The Most Comprehensive Resource for Compliance & Quality




700537          Failure Modes and Effects Analysis (FMEA) - An Effective Tool for Risk Management
700764          How to assess risk for the validaiton of Quality System software regulated by the FDA: FMEA process
                for software
700918          Failure Mode and Effects Analysis (FMEA): A tool to understand process improvement opportunities and
                controls
701152          'Preventive Action' - the often ignored side of CAPA: Use FMEA to build preventive action into your CAPA
                program
701138          Failure Modes and Effects Analysis - An effective Risk Management Tool
701365          Equipment and Process Change Control in Bio/Pharmaceutical Industry
700107          Managing Failure Investigations and OOS Situations - Regulatory Requirements and Strategies for
                Implementation
701074          Maintaining a Sustainable and Compliant Design Validation System and Using FMEA for Device
                Manufacturers




!   Recall
Course ID       Course Name

700787          Recalls, Removals, and Market Corrections in Compliance with FDA and ISO Requirements
700448          Medical Device Recalls: Being Ready
700196          Medical Device Complaints, MDR's and Recalls
700911          How to Manage a Medical Device Recall Efficiently and Effectively
700922          The Essentials of Food and Drug Administration Medical Device Regulations:A Primer for Manufacturers
                and Suppliers - Registration, Medical Device Reporting, Corrections and Removals (Recalls)
701311          Surviving Medical Device Recalls
700830          Complaint Handling, MDR's & Recalls
701438          Crisis Management and Risk Communication in Product Recovery and Product Recall




!   HR Related
Course ID        Course Name
700861           Human Factors Standards and Guidance’s for Medical Devices -- which documents apply to my situation?
701051           Applying Human Factors Best Practices for Medical Device Risk Management
700437           OSHA Training and Compliance for Medical Practices

                                                                                                                              Back to Top




                                                                                                           © Copyright, ComplianceOnline
09           www.complianceonline.com | 2600 E. Bayshore Road Palo Alto, CA 94303 | Ph: 650-620-3937 | Fax: +1-650-963-2556
Compliance O nline: M edical D evice T raining                                               Online
                                                                                     Compliance
                                                                                      The Most Comprehensive Resource for Compliance & Quality




700859         Addressing the Elusive Use Error: Meeting Regulatory Expectations for Identifying and Controlling Medical Device
               Use-Related Hazards
700123         Effective Training for FDA Compliance: What to train - How much to Train - How to Document Effectiveness



!   Role Related
Course ID      Course Name

700785         Challenges for the RA Professional, and How to Address Them
700988         Management Controls Under QSR and ISO 13485
700134         Management Controls needed for an effective QMS to meet FDA QSR and ISO 13485 regulations
700923         Investigator responsibility/Legal commitment in drug and device clinical research: the reality
700982         Critical Role of Quality Audit in GxP Compliance & Improvement
701095         Clinical Trials Process: Study Sponsor's and Investigator's Responsibilities
701347         What are the Investigator responsibilities in Research Involving Human Subjects: The International Conference on
               Harmonization (ICH) position
701345         What is the role of Data and Safety Monitoring in Clinical Research Involving Human Subjects - When and How?
701092         Clearing up Roles and Responsibilities in the GLPs




!   EU / Latin America Regulations
Course ID      Course Name

700153         European Clinical Data Requirements for the Medical Devices Directive
700184         Selling Medical devices in EU - a focus on MDD 93/42/EEC and CE marking & FDA regulations
700745         Medical Devices in the EU: CE Mark and 93/42/EEC Directive
700844         International GMP's for Medical Devices: Quality System requirements for USA, Europe, Canada and
               Japan
700847         4-Region internal audits: Medical Device Quality System audits that cover internal regulatory compliance
               for FDA, Europe, Canada and Japan
701369         Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs
700136         CE Marking Medical Devices: New Approach Directives (NAD) To Consider for Full Compliance
701175         Design History Files and Technical Files under US FDA and EU MDD
701261         European Filing & Registration Procedures
701260         Latin America – Understanding Regulatory Compliance Requirements Across Life Science Industry PART I
701267         Latin America – Understanding Regulatory Compliance Requirements Across Life Science Industry Part II
701259         The EU Clinical Trial Directive
701535         Updated EU filing and registration procedures (including the new variation rules coming in to force)
                                                                                                                                Back to Top


                                                                                                            © Copyright, ComplianceOnline
10          www.complianceonline.com | 2600 E. Bayshore Road Palo Alto, CA 94303 | Ph: 650-620-3937 | Fax: +1-650-963-2556
C omplianceO nline: Medical D evice T raining                                               Online
                                                                                    Compliance
                                                                                     The Most Comprehensive Resource for Compliance & Quality




!   Japan Regulations
Course ID       Course Name

700844          International GMP's for Medical Devices: Quality System requirements for USA, Europe, Canada and Japan
700847          4-Region internal audits: Medical Device Quality System audits that cover internal regulatory compliance for FDA, Europe,
                Canada and Japan
700846          GCP Audit of Clinical Evaluations for Japan: Requirements and expectations from the revised Japanese PAL
701276          Japanese PAL – Navigating the Japanese Pharmaceutical Affairs Law
701277          Japanese PAL – Dealing with a JPAL Quality Interface Agreement between the foreign manufacturer and MAH (Marketing
                Authorization Holder)
701291          Japanese PAL – JPAL change notifications and reporting between the foreign manufacturer, MAH and PMDA
701294          Understanding the JPAL (Japanese Pharmaceutical Affairs Law): A comprehensive course
701258          Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences PART I
701266          Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences PART II
701049          Japan PAL Audits performed abroad by the PMDA: What to expect and how to prepare
701290          Japanese PAL – JPAL QMS requirements in Ordinance 169 and differences to ISO 13485
701292          Japanese PAL – JPAL Technical, cultural and language challenges when dealing with MAH, PMDA, Distributors and
                Customers
701306          Japan's Medical Device Evaluation & Approval Process: Submitting the STED (Summary Technical Document)
701533          Japan – Regulatory Requirements and Compliance Processes for Life Science Products – Part I
701534          Japan – Regulatory Requirements and Compliance Processes for Life Science Products – Part II




!   Quality System
Course ID       Course Name

700140          Successful Implementation Strategies of Design for Six Sigma
700392          Critical Parameters and Design, Process and Purchasing Controls
700139          Design for Six Sigma in Medical Devices: Integration with the FDA Quality Systems Regulations
700921          The Essentials of Food and Drug Administration Medical Device Regulations: A Primer for Manufacturers and Suppliers;
                Part 1- Quality System Regulation
700953          Using HACCP Quality Plans to Improve Medical Device Compliance Outcomes
701310          Preparing and Executing Medical Device Quality Audits: How to Meet the FDA’s Expectations
700320          Management Controls Under QSR and ISO 13485
700411          Designing in Quality via Statistical Process Control
701057          What are DHF, DMR and DHR? - The FDA Quality Systems Regulations Documents Explained
700193          Supplier Evaluation and Assessment Program: How to meet FDA QSR and ISO 13485 requirements in a cost effective
                manner
                                                                                                                              Back to Top


                                                                                                           © Copyright, ComplianceOnline
11          www.complianceonline.com | 2600 E. Bayshore Road Palo Alto, CA 94303 | Ph: 650-620-3937 | Fax: +1-650-963-2556
Compliance O nline: M edical D evice T raining                                                  Online
                                                                                        Compliance
                                                                                        The Most Comprehensive Resource for Compliance & Quality




700254         Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements in a
               Relatively Paper-Free Manner
700316         Training Requirements and Practices to Assure QSR and ISO Compliance
700993         Regulatory Requirements for Personnel Training to Assure QSR and ISO Compliance
700134         Management Controls needed for an effective QMS to meet FDA QSR and ISO 13485 regulations
701447         Integrating Risk Management with the Quality System
701142         Quality Management System for Equipment Validation, Tracking, Calibration, and Preventive Maintenance
700788         Quality Systems Inspection Technique (QSIT), and How to use it to Your Advantage
700411         Designing in Quality via Statistical Process Control
701057         What are DHF, DMR and DHR? - The FDA Quality Systems Regulations Documents Explained
701084         Gage R & R - Improving the Reliability and Reducing the Variation of Your Measurement System




!   Clinical Compliance
Course ID      Course Name
700275         Establishing Effective Business Strategies for Managing Outsourced Services
701214         Clinical Trial auditing - identifying risks and building a more compliant and successful trial
701120         Analytical Instrument and Equipment Qualification in GXP and EPA Laboratories: USP <1058> and Beyond
700885         Analytical Instrument Qualification-Understanding the New USP draft Chapter
701122         Analytical Test Methods Validation: FDA, ICH and USP Requirements
700924         How does 21 CFR Part 11 help ensure data integrity and subject safety in clinical research
701068         Deploying Regulatory-Compliant Clinical Research Data Management Systems
701054         How to conduct a Clinical Trial in accordance with FDA regulations and how to avoid the common deficiencies observed
               during FDA clinical audits
701343         How to engage your Investigators to be more active on studies
700182         Implementing Clinical Trial Performance Metrics
700907         Ensuring Good Clinical Practice
701345         What is the role of Data and Safety Monitoring in Clinical Research Involving Human Subjects - When and How?
701382         Clinical Statistics for Non-statisticians
701388         Understanding Attribute Acceptance Sampling including Z1.4 and c=0 Plans
701386         How to Write an ICH-Compliant Clinical Study Report
701348         The Secret of Study Conduct Documentation to ensure a successful Audit: What the FDA Inspectors looks for
701451         How to Create and Understand A Statistical Analysis Plan for A Clinical Study
701440         FDA Clinical Trial Requirements, Regulations, Compliance and GCP (Good Clinical Practice)
701457         FDA’s Clinical Trials Audit procedures companies should conduct as part of its monitoring program
700880         Why investigators often lose money in conducting sponsored clinical trials
701265         Webinar - Computer Systems Used In Clinical Trials
701555         Auditing Clinical Trials for GCP Compliance
                                                                                                                                  Back to Top


                                                                                                                © Copyright, ComplianceOnline
12          www.complianceonline.com | 2600 E. Bayshore Road Palo Alto, CA 94303 | Ph: 650-620-3937 | Fax: +1-650-963-2556
C omplianceO nline: Medical D evice T raining                                                 Online
                                                                                      Compliance
                                                                                      The Most Comprehensive Resource for Compliance & Quality




!   Laboratory Compliance
Course ID       Course Name

701305          CLIA Guidelines on Quality Control and Quality Assessment
701304          Decoding CLIA (Clinical Laboratory Improvement Amendments) Regulations: Calibration, Calibration
                Verification and Method Validation
700204          Good Laboratory Practice Regulations
701246          Good Laboratory Practices (GLP): Documenting Deviations & Unexpected Circumstances
701127          Investigating Out of Specification Guidance (OOS) in the Laboratory
700951          Learning from Laboratory-related FDA Warning Letters
701280          LIMS (Laboratory Information Management System) Validation in One Third the Time
701309          System Based Inspections - Laboratory Controls
700989          Understanding and Implementing ISO 17025 - Requirements, Strategies and Tool Kits for Laboratory
                Accreditation
701336          Understanding and Preparing for System Based Inspections: Laboratory Control System
700919          ISO 17025 - The elements of good management system for the competence of testing and calibration in
                laboratories
701340          Development and Validation of Dissolution Procedures
701002          Development and Validation of Stability Indicating Methods-Planning-Design-Conduct-Documentation
701339          Practical Approaches to Compliance with USP<467> Residual Solvents
700900          Selection and Use of (Certified) Reference Material- Strategies for FDA Compliance and Tools for
                Implementation
701325          Auditing Analytical Laboratories for FDA Compliance
701334          Understanding and Preparing for System Based Inspections: Materials System
701333          Understanding and Preparing for System Based Inspections: Production System
701364          Auditing the QC Microbiology Laboratory for FDA Compliance
701419          Proficiency Testing: How to Pass with Flying Colors and What to Do If You Don't
701411          Out-of-Specification Investigations, Identifying the Attributable cause or Laboratory Error
701439          Laboratory Investigations Relating to Sample Re-Analysis: Covering the basics before being called out
701458          Strategies to establish and manage a compliant contemporary microbiology laboratory
701505          Archiving GLP Records: How Archiving Makes or Breaks the Audit
701439          Laboratory Investigations Relating to Sample Re-Analysis: Covering the basics before being called out
701523          Leaping into Lab: Everything about Waived Testing
                                                                                                                                Back to Top




                                                                                                              © Copyright, ComplianceOnline
13          www.complianceonline.com | 2600 E. Bayshore Road Palo Alto, CA 94303 | Ph: 650-620-3937 | Fax: +1-650-963-2556
Compliance O nline: M edical D evice T raining                                                Online
                                                                                      Compliance
                                                                                      The Most Comprehensive Resource for Compliance & Quality




!   Water System Compliance
Course ID      Course Name

701301         Water System Compliance - Understanding and Controlling Endotoxin
701358         Water System Compliance - Water System Validation by Logic Instead of Tradition
701359         Water System Compliance - Reducing Water Microbial Excursions and Improving Investigations
701302         Water System Compliance - Successful Sanitization Approaches for Trouble-Free Water Quality
701477         Water System Mythology: Origins and Examples
701283         Water System Compliance - What Makes Water Systems Have Microbial Quality Problems
701300         Water System Compliance - Harmonizing Water Microbial Testing for Optimal Quality Control
701351         Webinars Series on Water System Compliance for Medical Devices, Diagnostics, Pharmaceuticals, and
               Biologics
701303         Water System Compliance - Implementing Changes to a Validated System
701478         The Microbiology Lab’s Role in Contamination Control Support of Manufacturing




!   OSS
Course ID       Course Name

700107          Managing Failure Investigations and OOS Situations - Regulatory Requirements and Strategies for
                Implementation
700219          Method Development With the Intention of Minimizing OOS Results
701127          Investigating Out of Specification Guidance (OOS) in the Laboratory
701353          Failure or OOS Investigation for Sterility or Bioburden Testing
701354          Failure or OOS Investigation for environmental monitoring (viable and nonviable)
701487          Handling OOS(Out-of-Specification)/OOT(Out-of-Trend) Results and Failure Investigations
701526          Handling OOS Test Results and Failure Investigations




!   Marketing / Sales
Course ID       Course Name

700873          Post-Marketing Strategies for Medical Devices – how to keep your device on the market
700955          Premarket Approval (PMA) agreement with FDA for the medical device companies - the Requirements
700921          The Essentials of Food and Drug Administration Medical Device Regulations: A Primer for Manufacturers and
                Suppliers; Part 1- Quality System Regulation
                                                                                                                                Back to Top


                                                                                                            © Copyright, ComplianceOnline
14          www.complianceonline.com | 2600 E. Bayshore Road Palo Alto, CA 94303 | Ph: 650-620-3937 | Fax: +1-650-963-2556
C omplianceO nline: Medical D evice T raining                                                Online
                                                                                     Compliance
                                                                                     The Most Comprehensive Resource for Compliance & Quality


700319          Complaint Handling and Management: From Receipt to Trending
700784          510(k) Preparation for a Small to Medium-Sized Company
701144          The Reimbursement Process
700701          A Beginners Guide to Importing Medical Devices
701192          Medical Device Complaint Handling: Solving Your Toughest Reporting Problems
701312          GHTF (Global Harmonization Task Force) is changing the global medical device industry; will it help you or hurt you?
701087          The IDE (Investigational Device Exemption) - It's Purpose and Preparation
700451          CAPA systems in Post Marketing Surveillance
700912          Tracking Use Error Risks in Post-Market Surveillance and CAPA Activities
701314          How CAPA and complaint handling should interact in Medical Device - Simplification of the processes is often
                needed to preserve their effectiveness
701385          The Future of the 510K: Can the past predict the future?
701383          Construct a 'Real' 510(k) Submission: From Start to Finish
701398          Post Market Surveillance in Today's Regulatory Environment
701459          How can Quality, Manufacturing, Marketing and R&D Identify and Manage Risks to Future Product Success during
                the Product Development Process?
701287          Development and Audit of Complaint Handling and MDR Processes
701155          Risk Evaluation and Mitigation Strategies (REMS) what you need to know in order to comply with FDA's new
                requirements
701109          Off-Label Promotion of Medical Devices: Maximizing Your Performance Claims within FDA's Framework of
                Acceptable Practices
701512          How Medical device companies can meet the new standards of Comparative Effectiveness Research (CER)?
701537          Presenting Risk Information in Drug and Medical Device Promotion: FDA's Update on Draft Guidance for Industry


!   Packaging & Labeling
Course ID       Course Name

700245          Reprocessing Reusable Medical Devices - Cleaning & Labeling Requirements - validations
700831          Reprocessing REUSABLE Medical Devices-Cleaning & Labeling Requirements
700879          Beyond Usable to Valuable: Usability Testing on Medical Device LabelingOff-Label Promotion of Medical
701109          Off-Label Promotion of Medical Devices: Maximizing Your Performance Claims within FDA's Framework of
                Acceptable Practices
701141          FDA's Update on Medical Device Labeling Changes
701143          FDA Requirements for Device Labeling: Development, Contents, Distribution, and Changes
701315          Comparability Protocols (CPs): How and when to use them for POST APPROVAL CHANGES
701317          Compliance Packaging/Labeling Requirements Overview
701335          Understanding and Preparing for System Based Inspections: Packaging and Labeling System
701395          Product Labeling Requirements for Devices and Update on Structured Product Labeling (SPL)
701408          Be Ready for UDI - The U.S. FDA's UDI Rule is Coming in 2010 - Know What's Ahead!
                                                                                                                               Back to Top




                                                                                                           © Copyright, ComplianceOnline
15          www.complianceonline.com | 2600 E. Bayshore Road Palo Alto, CA 94303 | Ph: 650-620-3937 | Fax: +1-650-963-2556
Compliance O nline: M edical D evice T raining                                               Online
                                                                                     Compliance
                                                                                     The Most Comprehensive Resource for Compliance & Quality




!   Risk Management
Course ID      Course Name

700109          Risk Management for Medical Devices: Best practices to make your FMEA process work for you
700132          Risk Management for Medical Devices: Putting ISO/EN 14971 Into Practice
700524          Overview of ISO 14971:2007 Medical Device Risk Management standard updated
700450          Risk Communication of Medical Device Failures
700621          The Use and Mis-use of FMEA in Medical Device Risk Management
700622          Overall Residual Risk and Risk Acceptability for Medical Devices
700708          ISO 14971:2007 -- The Newly Revised Risk Management Standard for Medical Products
700902          Medical Device Software Risk Analysis
701051          Applying Human Factors Best Practices for Medical Device Risk Management
701083          Test Method Validation Basics - Ensuring Adequacy and Reliability of Your Test Methods
701176          Product Risk Management under FDA and ISO 14971:2007
700525          Integrating Risk Management with the CAPA process
700125          10 Steps to Effective Risk Analysis for US FDA and ISO 14971 Compliance
700859          Addressing the Elusive Use Error: Meeting Regulatory Expectations for Identifying and Controlling Medical
                Device Use-Related Hazards
700713          Conducting and Documenting Proper Risk Analysis In compliance with ISO 14971
700813          Hazard Analysis & Risk Management - New 14971
700354          Documenting a Risk-Based Quality System – for Compliance and Cost-Savings
700817          Process Mapping - Risk-Based P&PC
700819          Product Risk Management File Case Study
700117          How to do an Effective Hazard Analysis to meet FDA and ISO13485:2003 risk management requirements
700706          How to Conduct a Hazard Analysis/Risk Assessment-Exercise
701043          Reduce testing using risk-based validation - Test Plans, Testing, and Issue Tracking
701268          Risk and Hazard Assessment for Medical Devices - ISO 14971
701445          Best practices for creating a Risk Management File
701447          Integrating Risk Management with the Quality System
701497          The 510(k) Process and Risk Management
701500          Purchasing Controls and Risk Management: How to Manage Resources in the Face of Increased Scrutiny
                by FDA and Other Regulators
701470          How to reduce software validation project time and use risk management to improve system performance
701520          FDA Warning Letter - Consent Decree Software Validation                                                        Back to Top




                                                                                                           © Copyright, ComplianceOnline
16          www.complianceonline.com | 2600 E. Bayshore Road Palo Alto, CA 94303 | Ph: 650-620-3937 | Fax: +1-650-963-2556
C omplianceO nline: Medical D evice T raining                                                Online
                                                                                     Compliance
                                                                                     The Most Comprehensive Resource for Compliance & Quality




!   Cleaning Validation
Course ID       Course Name

700088          Cleaning Validation Regulations for Biopharmaceuticals: Strategies for Compliancec
700245          Reprocessing Reusable Medical Devices - Cleaning & Labeling Requirements - validations
701400          Cleaning Validation Swab Recovery Studies and Analysis
700404          Cleanroom Design, Certification & Classification
700630          Cleanroom Operation, Maintenance and Operators
700790          Cleaning Validation - Chemical & Microbiological Aspects
700831          Reprocessing REUSABLE Medical Devices-Cleaning & Labeling Requirements
700915          Pharmaceutical Cleaning Validation
700995          Designing an Effective Cleaning and Disinfection Program for Pharmaceutical, Biotech, and Medical Device
                Cleanrooms
701023          Contamination Control 101 in Pharmaceutical, Biotech, and Medical Device Clean rooms
701149          Cleaning & Cleaning Validation; an Overview
701184          Using ICH Q9 and Recent FDA Comments as the Foundation for the Planning, Development and Execution
                of Risk-Based Cleaning Validation Studies
701185          Auditing Strategies for Cleaning Processes and Cleaning Validation
701278          Sterilization as a Benchmark for Cleaning Validation and Control




!   Combination Products
Course ID       Course Name

701150          Bringing Compliance To Design Control For Older Products
701230          Bringing Compliance to Design Control through Life Cycle Management of Older Medical Devices and
                Surgical Instruments
701158          Combination products and convergence: an overview of clinical benefits, regulatory issues and
                manufacturing challenges - part 1
701160          Combination products and convergence: an overview of clinical benefits, regulatory issues and
                manufacturing challenges - part 2

                                                                                                                               Back to Top




                                                                                                           © Copyright, ComplianceOnline
17          www.complianceonline.com | 2600 E. Bayshore Road Palo Alto, CA 94303 | Ph: 650-620-3937 | Fax: +1-650-963-2556
Compliance O nline: M edical D evice T raining                                              Online
                                                                                    Compliance
                                                                                    The Most Comprehensive Resource for Compliance & Quality




!   IT and Software
Course ID      Course Name

700351          Medical IT Device Security: Why Medical Device Manufacturers Must Take the Lead and ive Regulatory Compliance
700291          Understanding the FDA guideline on "Off-The-Shelf Software Use in Medical Devices' and the pitfalls that are
                associated with using OTS software"
700959          The FDA’s proposed Medical Device Data System (MDDS) rule and its implications for currently regulated and
                unregulated vendors and providers
700902          Medical Device Software Risk Analysis
700100          How to Select Off-The-Shelf Software for Your Medical Devices While Avoiding Common OTS Pitfalls and Meeting
                the FDA's Guidelines
700171          Tools to Enable Better Regulatory Compliance for Medical Device Software
700078          Change Control for Computer Systems - strategies and tools for FDA compliance
700458          Configuration Management and Change Control for Computer Systems
700390          Quantitative Approach to User Requirements Risk Assessment
700264          Designing & Testing Products to Meet the Needs of Today's Lightning Environment
701135          Software Verification and Validation For FDA-Regulated Industries
701362          Successful FDA Pre-approval Inspections of Computer Systems




!   ISO Standards
Course ID      Course Name

700132          Risk Management for Medical Devices: Putting ISO/EN 14971 Into Practice
700135          Internal Auditing Essentials for Medical Device Manufacturers to comply with FDA QSR and ISO13485
700524          Overview of ISO 14971:2007 Medical Device Risk Management standard updated
700708          ISO 14971:2007 -- The Newly Revised Risk Management Standard for Medical Products
701003          Understanding ISO 13485 vs. ISO 9001 for Successful QMS in Medical Device Industries
701342          FDA and ISO mandates for Old and New Medical Devices Products and Surgical Instruments
701369          Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs
700786          ISO 13485 Made Easy
700993          Regulatory Requirements for Personnel Training to Assure QSR and ISO Compliance
700098          Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements
700125          10 Steps to Effective Risk Analysis for US FDA and ISO 14971 Compliance
701176          Product Risk Management under FDA and ISO 14971:2007
701237          ISO 13485:2003 - A Straightforward Interpretation with Recommendations for Easy Implementation

                                                                                                                               Back to Top



                                                                                                          © Copyright, ComplianceOnline
18          www.complianceonline.com | 2600 E. Bayshore Road Palo Alto, CA 94303 | Ph: 650-620-3937 | Fax: +1-650-963-2556
C omplianceO nline: Medical D evice T raining                                                Online
                                                                                     Compliance
                                                                                      The Most Comprehensive Resource for Compliance & Quality




700320          Management Controls Under QSR and ISO 13485
700134          Management Controls needed for an effective QMS to meet FDA QSR and ISO 13485 regulations
700193          Supplier Evaluation and Assessment Program: How to meet FDA QSR and ISO 13485 requirements in a cost
                effective manner
701268          Risk and Hazard Assessment for Medical Devices - ISO 14971




!   Microbial Compliance
Course ID       Course Name

701353          Failure or OOS Investigation for Sterility or Bioburden Testing
701364          Auditing the QC Microbiology Laboratory for FDA Compliance
701186          Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing
701129          A Practical Approach to Microbial Data Deviation Investigations
701021          Validating Disinfectants for Pharmaceutical and Biotech Operations
701283          Water System Compliance - What Makes Water Systems Have Microbial Quality Problems
701300          Water System Compliance - Harmonizing Water Microbial Testing for Optimal Quality Control
701359          Water System Compliance - Reducing Water Microbial Excursions and Improving Investigations
701208          Auditing and Compliance of Biopharmaceutical API Facilities
701145          Ensuring the Microbiological Integrity of Pharmaceutical and Biopharmaceutical Facilities
701313          Objectionable Microorganisms: Considering the Risk
701139          Practical Aspects of Aseptic Processing
701354          Failure or OOS Investigation for environmental monitoring (viable and nonviable)
701376          Objectionable Microorganisms in an Aseptic Environment
701307          Solutions for addressing microbial excursions in Medical device, Pharmaceutical, and Biotech industries
701241          Environmental Monitoring and the Contamination Control Plan
701416          Pathogen Control Programs for food Manufacturers
701396          Microbiological Risk: Do I Really Need to Test Raw Materials for Microorganisms?
701478          The Microbiology Lab’s Role in Contamination Control Support of ManufacturingStrategies to establish and
                manage a compliant contemporary microbiology laboratory

                                                                                                                                Back to Top




                                                                                                            © Copyright, ComplianceOnline
19          www.complianceonline.com | 2600 E. Bayshore Road Palo Alto, CA 94303 | Ph: 650-620-3937 | Fax: +1-650-963-2556
Compliance O nline: M edical D evice T raining                                              Online
                                                                                    Compliance
                                                                                    The Most Comprehensive Resource for Compliance & Quality




!   Facility Design
Course ID      Course Name

701210          Facility Design Considerations
701370          Facility Design for Aseptic Processing – construction concepts, operation and controls
701168          Facility Operations, Maintenance, and Calibration
701504          How to investigate environmental monitoring excursion limits




!   Vendor/Supplier/CRO Compliance
Course ID      Course Name

700733         Supplier Capability Audits - how to tell if a supplier "gets it."
700957         Pack of two courses: The essentials of Food and Drug Administration Medical Device Regulations: A primer
               for manufacturers and suppliers
701036         Establish and Maintain an Effective Supplier Qualification Program
700384         Integrating Risk Management with Supplier Management
701368         CROs (Clinical Research Organizations) – Identification, Selection, and Management for Maximum Results &
               Value
701193         How to perform effective supplier audits, and avoid FDA 483’s and Warning letters
700916         Implementing a GCP Vendor Qualification Program:Ensuring your vendors are in compliance with FDA
               requirements
700151         Best Practices in Supplier Quality Management
701014         Internal Audits and Supplier/Subcontractor Audits
701228         Virtual Manufacturing - how to manage third party contract manufacturers
701379         Control of Products and Services Obtained from Suppliers
701444         How do I keep FDA happy with my contract manufacturer?
701462         Managing the Medical Device Supply Chain – As per GHTF guidance document
700905         Securing your international supply chain:What heparin and DEG have to teach us
700436         'Performing effective supplier audits: a coming FDA compliance focus'
701500         Purchasing Controls and Risk Management: How to Manage Resources in the Face of Increased Scrutiny by
               FDA and Other Regulators
701536         Outsourced processes and ISO 9001:2008 – understanding the guidance changes and approach to take for
               supplier evaluation and assessment
701567         Supplier Evaluation and Assessment
                                                                                                                              Back to Top




                                                                                                          © Copyright, ComplianceOnline
20          www.complianceonline.com | 2600 E. Bayshore Road Palo Alto, CA 94303 | Ph: 650-620-3937 | Fax: +1-650-963-2556
Compliance O nline: M edical D evice T raining                                              Online
                                                                                    Compliance
                                                                                    The Most Comprehensive Resource for Compliance & Quality




Keep In Touch With Us

Thank you for your interest in ComplianceOnline
If you have a question, comment, feedback on our portal or any other specific inquiry, please contact us at:



            Postal Address :
            2600 E. Bayshore Road Palo Alto, CA 94303
---------------------------------------------------------------------------------

            Customer Support :
            Email Customer service - customercare@complianceonline.com
            Call us at this number: +1-650-620-3937
            Fax number: +1-650-963-2556
---------------------------------------------------------------------------------

            For assistance in attending a webinar please email to :
            webinarassist@complianceonline.com or Call: +1-650-620-3915
            (Our support team is available from Monday to Friday, 7:30am EST - 6:00pm EST)
                                                                                                                " Back to Contents




                                                                                                          © Copyright, ComplianceOnline
             www.complianceonline.com | 2600 E. Bayshore Road Palo Alto, CA 94303 | Ph: 650-620-3937 | Fax: +1-650-963-2556