Pharmaceutical Master Catalogue by ComplianceOnline

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 Compliance Training for
 Pharmaceutical Companies
 Last Updated Dec, 2009




  ComplianceOnline:Pharmaceutical Training
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  quirements are being met. Regulatory requirements include FDA GXPs, reporting mandates, drug safety
  standards, marketing laws and compliance requirements.ComplianceOnline.com uniquely provides training
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T ABLE          OF      C ONTENTS:

FDA Guidelines..........................................................................................................................................................................................1
FDA Inspection.........................................................................................................................................................................................2
System Based Inspection....................................................................................................................................................................................2
EU / Latin America Regulations ........................................................................................................................................... 3
Japan Regulations ................................................................................................................................................................................3
Auditing...............................................................................................................................................................................................................3
CAPA......................................................................................................................................................................................................................4
Quality System....................................................................................................................................................................................................5
FDA Validation .....................................................................................................................................................................................5
GMP / CGMP...........................................................................................................................................................................................................6
Documentation.............................................................................................................................................................................................6
OOS.............................................................................................................................................................................................................7
Electronic Records and 21 CFR Part 11...................................................................................................................................................7
Software Regulations (validation verifications etc.)....................................................................................................................8
IT & CSV ...........................................................................................................................................................................................8
Risk Management ...................................................................................................................................................................................8
Biopharmaceuticals / Biotechnology..............................................................................................................................................................................9
Pharmacovigilance & Drug safety.................................................................................................................................................................................10
Cleaning Validation............................................................................................................................................................................................10
Clinical Compliance................................................................................................................................................................................................................11
Microbial Compliance............................................................................................................................................................................................................12
Water System Compliance................................................................................................................................................................................13
Sterilization...............................................................................................................................................................................................13
Facility Design...........................................................................................................................................................................................14
Packaging & Labeling................................................................................................................................................................................14
Laboratory Compliance .....................................................................................................................................................................14
Marketing / Sales...................................................................................................................................................................................15
Combination products..................................................................................................................................................................................................15




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                       www.complianceonline.com | 2600 E. Bayshore Road Palo Alto, CA 94303 | Ph: 650-620-3937 | Fax: +1-650-963-2556
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    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
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!    FDA Guidelines
Course ID           Course Name

700339              Risk Based Validation of Software and Computer Systems
701135              Software Verification and Validation For FDA-Regulated Industries
701190              The 'New' FDA Prescription drug labeling requirements: Learn to create Prescription Drug Labeling in compliance with the
                    rule and understand the essential elements'
701317              Compliance Packaging/Labeling Requirements Overview
701155              Risk Evaluation and Mitigation Strategies (REMS) what you need to know in order to comply with FDA's new requirements
701229              Meeting FDA Requirements for Over-the-Counter / OTC Drug Labeling
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
701054              How to conduct a Clinical Trial in accordance with FDA regulations and how to avoid the common deficiencies
                    observed during FDA clinical audits
700986              Complaint Handling in Compliance with FDA and ISO Regulations
701047              Risk Management and the Risk Assessment Process
701025              EFFECTIVE INVESTIGATIONS AND CORRECTIVE ACTIONS (CAPA) Establishing and resolving the root causes
                    of deviations, problems and failures
700159              What will FDA expect and request from your firm during Design Control portions of Inspections?
700691              Legal Writing Skills to Prepare for Effective Regulatory Submissions - FDA, EU EMEA and EU Notified Body

700155              FDA's Current Thinking for Industry cGMPs for Phase 1 INDs
700852              FDA Expectations for Cell, Tissue and Gene Therapy Products
700754              Practical tips to comply and implement the Adverse Event Reporting requirement of the new Dietary
                    Supplement and Nonprescription Drug Consumer Protection Act
700842              Understanding the recent FDA Gudiance on Computerized Systems Used in Clinical Investigations
701041              The Food And Drug Amendments Act of 2007-Does IT Affect You?
700198              Parallel trade of medicinal products in the EU - Latest case law and Commission decisions
700262              Parallel Scientific Advice: How effective is the system established between the EMEA and the FDA
700195              Update of Pharmaceutical law in the EU -Focus on Generic Opportunities & Biosimilars

701361              Understanding the new NAIC (National Association of Insurance Commissioners) Model Regulation
701242              Validation and Use of Excel® Spreadsheets in Regulated Environments
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!   FDA Inspection
Course ID      Course Name

701038         Documenting & Conducting CAPA Investigations
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
701236         How to Prepare for, Manage, and Follow-up to an FDA 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
700894         Preparing for FDA Pre-Approval Inspections
701187         cGMP 'Pitfalls' in the QC Laboratory-Preparing the QC Laboratory and Staff for an FDA Inspection
701203         Surprise FDA GMP inspection - how to prepare for it
701410         Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations
701486         Preparing for and handling FDA inspections - Laboratory Regulatory Inspections




!   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
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!   EU / Latin America Regulations
Course ID       Course Name

700195          Update of Pharmaceutical law in the EU -Focus on Generic Opportunities & Biosimilars
701259          The EU Clinical Trial Directive
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
701261          European Filing & Registration Procedures
701367          Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities




!   Japan Regulations
Course ID       Course Name

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
701533          Japan – Regulatory Requirements and Compliance Processes for Life Science Products – Part I




!   Auditing
Course ID       Course Name

701065          Auditing an Active Pharmaceutical Ingredient (API) Contract Manufacturing Organization (CMO)
701186          Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing
701208          Auditing and Compliance of Biopharmaceutical API Facilities
700846          GCP Audit of Clinical Evaluations for Japan: Requirements and expectations from the revised Japanese PAL
700853          GLP Compliance Audits: What to look out for at a New Nonclinical CRO
                                                                                                                                Back to Top



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701054          How to conduct a Clinical Trial in accordance with FDA regulations and how to avoid the common
                deficiencies observed during FDA clinical audits
701214          Clinical Trial auditing - identifying risks and building a more compliant and successful trial
701185          Auditing Strategies for Cleaning Processes and Cleaning Validation
700260          Auditing a Process-based System
700884          Computer System Auditing 21CFR Part 11 Compliance
701325          Auditing Analytical Laboratories for FDA Compliance
701364          Auditing the QC Microbiology Laboratory for FDA Compliance




!   CAPA
Course ID      Course Name

701146          Corrective And Preventive Action: CAPA-A Risk Mitigating Quality System
700168          Best Practices on Six Sigma and CAPA Convergence
700137          CAPA - Best Practices and Common Pitfalls for FDA Regulated Industries
700141          Root Cause Analysis for Corrective and Preventive Action (CAPA)
700299          CAPA Essentials - core principles and practices needed to implement an effective and efficient CAPA process
700914          The CAPA Trap or Common Problems and Pitfalls
700966          Root Cause Analysis for CAPA Management (Shutting Down the Alligator Farm)
700994          Effective CAPA Management: How to Implement a Risk-based Approach to Improve Your Quality System
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
701096          Deviations and Process Failures within a CAPA program
700377          From CAPA to Capability: Shifting the Focus to Profitability
701389          Avoid the common confusion surrounding Corrections and CAPA
701426          CAPA for Your Work life and Beyond: Effective CAPA techniques and organizational skills you must know
                before solving any problem




!   Quality System
Course ID      Course Name

700131          Improving the Quality of Pharmaceutical Product Safety Reporting through the use of Metrics
700256          Experiences of managing a quality management system for a virtual pharmaceutical company
701184          Using ICH Q9 and Recent FDA Comments as the Foundation for the Planning, Development and Execution of
                Risk-Based Cleaning Validation Studies
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700994         Effective CAPA Management: How to Implement a Risk-based Approach to Improve Your Quality System
701146         Corrective And Preventive Action: CAPA-A Risk Mitigating Quality System
700165         Effective DOE Strategies to Streamline your Processes for FDA Regulated Environment
701010         Quality Expectations for Drugs and Biologics during Early Development: Phase 2
701011         Quality Expectations for Drugs and Biologics during Early Development: Phase 3 and NDA
700949         Quality Expectations for Product Development CMC Activities: R & D, GLP or GMP
700893         Quality by Design: what the FDA wants, what you must do, how you can deliver to their expectations and
               what relief you can expect
700373         Process Capability Analysis and Process Analytical Technology
700862         Overview of Quality by Design
701365         Equipment and Process Change Control in Bio/Pharmaceutical Industry
701441         ICH Q10; moving from GMPs to a Pharmaceutical Quality System
701423         Pragmatic techniques to Pharmaceutical Systems Project Management – A case Study
701463         Best Practices in Supplier Management




!   FDA Validation
Course ID      Course Name

700088         Cleaning Validation Regulations for Biopharmaceuticals: Strategies for Compliance
700187         Viral Validation for Biopharmaceuticals
700480         Pharmaceutical Manufacturing Process Validation
700827         Biopharmaceutical Viral Safety from Process Design through Validation
700915         Pharmaceutical Cleaning Validation
701147         PROCESS ANALYTICAL TECHNOLOGY (PAT): The Impact on Pharmaceuticals Manufacturing and Validation
               Needs/Requirements
701304         Decoding CLIA (Clinical Laboratory Improvement Amendments) Regulations: Calibration, Calibration Verification
               and Method Validation
700790         Cleaning Validation - Chemical & Microbiological Aspects
701149         Cleaning & Cleaning Validation; an Overview
700342         Introduction to Process Capability (Cp, CpK, Pp, Ppk)
701165         ASTM (American Society for Testing and Materials) E2500: A New Approach to Validation
701242         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
701363         Risk-Based Validation of cGMP Systems
700456         Verification of Compendial Methods Understanding the New USP Chapter <1226>
700888         How To Build Quality Into Commissioning And Validation
701422         Implement Key Validation for Chromatographic Methods
701506         Master Verification and Validation Planning to Meet Tougher U.S. FDA Requirements
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!   GMP / CGMP
Course ID      Course Name

700346         Bringing FDA Pharmaceutical GMPs into the 21st Century
700156         FDA's cGMPs for the 21st Century Initiative
700427         Implementing a Risk-Based Internal CGMP Annual Audit Program
700234         CGMPs for Investigational drugs and Biologics
701320         Advanced Topics in Good Documentation for GXPs
700811         The New Dietary Supplements CGMPs
701187         cGMP 'Pitfalls' in the QC Laboratory-Preparing the QC Laboratory and Staff for an FDA Inspection
701009         GMP Expectations for Products Used in Early Phase IND Studies
700205         FDA's Expectations for cGMPs for Analyst/Process Chemists
700167         cGMP System Strategies for Cost effective Compliance
700872         Differences in GMP Requirements between Drugs and Biologicals
701275         Revised USP 111: A valuable tool to expedite your GMP Bioassays
700871         Monoclonal Antibodies and Therapeutic Proteins: Designing GLP Compliant Nonclinical Programs to Meet FDA
               Expectations
701048         Understanding the Current FDA Requirements for Raw Materials and Components
701363         Risk-Based Validation of cGMP Systems
701320         Good Documentation Practices for GXPs
701397         Implementing Disposable Technologies in a GMP Facility: A case study
701441         ICH Q10; moving from GMPs to a Pharmaceutical Quality System
701508         GCP and FDA Regulations with regard to Investigator Responsibility - How to get your PI more involved in
               the clinical Research process
701509         Clinical Trial Regulations and GCP Compliance as they relate to Adverse Events - How to Assess and report AEs and SAEs




!   Documentation
Course ID      Course Name

700788         Best Practices for Writing an Effective SOP to Lead to Successful FDA Inspections
700987         Effective Records, Document Control, and SOPs
700331         Lean Documents and Document Control
700896         Risk Assessment-Compliance Using Easy To Fill Out Documentation
701038         GAMP Validation Protocols for Efficient Documentation
701085         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
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701320         Good Documentation Practices for GXPs
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
701471         Mastering Change Control Before It Masters You - An Essential Course for Drug Master File ’Owners’ AND
               Finished and Supplied Product Manufacturers
701505         Archiving GLP Records: How Archiving Makes or Breaks the Audit




!   OOS
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
701411         Out-of-Specification Investigations, Identifying the Attributable cause or Laboratory Error
701503         You have a sterility or Bioburden test failure - Now what?




!   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
701216          Software validation and 21 CFR Part 11 remediation planning: FDA inspection strategies
700992          Organization of Clinical Datasets in eCTD Submissions
701344          How does 21 CFR Part 11 help ensure data integrity and subject safety in clinical research
700619          Part 11 – Electronic Records and Electronic Signatures
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!   Software Regulations (validation verifications etc.)
Course ID       Course Name

700221         How to successfully audit software systems, and thereby avoid having FDA write software-related 483's and
               warning letters
700318         Understanding the new International and FDA accepted Software Development Standard IEC 62304
700339         Risk Based Validation of Software and Computer Systems
700443         Using the FDA guidance 'General Principles of Software Validation' to strengthen your firm's software FDA
               compliance'
701135         Software Verification and Validation For FDA-Regulated Industries
700444         Implementing the new International and FDA accepted Software Development Standard IEC 62304




!   IT & CSV
Course ID       Course Name

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
701113         FDA requirements for the Validation of Computer Systems
700710         Computer Validation Foundations: Common Sense Practices for Compliance – Auditable Testing Practices
700709         Computer Validation Foundations: Common Sense Practices for Compliance – Part 1 The Auditable Validation Package
700711         Computer Validation Foundations: Common Sense Practices for Compliance – Part 3 Staying Validated
700674         Information Technology Change Control in cGMP regulated environments
701265         Webinar - Computer Systems Used In Clinical Trials




!   Risk Management
Course ID      Course Name

700093         Biopharmaceuticals and Risk Management: What do ICH Q8 and Q9 mean?
700236         Implementation of the ICH Q9 Guideline on Quality Risk Management
701184         Using ICH Q9 and Recent FDA Comments as the Foundation for the Planning, Development and Execution of
               Risk-Based Cleaning Validation Studies
701214         Clinical Trial auditing - identifying risks and building a more compliant and successful trial
701207         Delivering Biopharmaceutical Facilities in a Risk Based World: The Role of GEP, QbD, and E2500
701155         Risk Evaluation and Mitigation Strategies (REMS) what you need to know in order to comply with FDA's new requirements
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701189         Auditing and Qualifying Suppliers and Vendors – An Effective Risk Based Approach
701146         Corrective And Preventive Action: CAPA-A Risk Mitigating Quality System
701047         Risk Management and the Risk Assessment Process
701062         Understanding the Pharmaceutical Supply Chain in China Risks, Rewards, Solutions
700817         Process Mapping - Risk-Based P&PC
701066         Quality Risk Management Using Failure Modes, Effects and Criticality Analysis
700971         Getting the Most Out Of Data Mining for Pharmacovigilance and Risk Management




!   Biopharmaceuticals / Biotechnology
Course ID      Course Name

700088         Cleaning Validation Regulations for Biopharmaceuticals: Strategies for Compliance
700093         Biopharmaceuticals and Risk Management: What do ICH Q8 and Q9 mean?
700220         Designing Viral Clearance Studies for Biopharmaceuticals
700187         Viral Validation for Biopharmaceuticals
700516         Viral Safety of Biopharmaceuticals from Process Development to Licensure
700827         Biopharmaceutical Viral Safety from Process Design through Validation
701207         Delivering Biopharmaceutical Facilities in a Risk Based World: The Role of GEP, QbD, and E2500
701186         Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing
701208         Auditing and Compliance of Biopharmaceutical API Facilities
701145         Ensuring the Microbiological Integrity of Pharmaceutical and Biopharmaceutical Facilities
700932         Review Validation Requirements Based on ICH Q9 "Quality Risk Management
700346         Bringing FDA Pharmaceutical GMPs into the 21st Century
700475         How to set up a small-volume radiopharmaceuticals manufacturing facility
700191         Implementing Process Controls for Optimum Performance of Cell-Based Assays
701365         Equipment and Process Change Control in Bio/Pharmaceutical Industry
701464         Risk mitigation and safe usage and storage of flammable liquids used in labs and pharma manufacturing
701421         Microgranules: How can you develop and manufacture them without the need of specialized equipment?
701427         Dry Powder Inhalers: Why could it be the future for pulmonary delivery?
701366         Cell Culture Media Filtration - Points to Consider
701481         Viral Safety for Biopharmaceuticals used in Clinical Trials - The Impact of the New EMEA Guideline
701493         Managing Immunogenicity Risk in Biopharmaceuticals
701504         How to investigate environmental monitoring excursion limits
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!   Pharmacovigilance & Drug safety
Course ID      Course Name

700081         The Changing Face of Pharmacovigilance and drug Safety Compliance and Inspections: Implications and Best
               Practices for Companies Marketing ugs in EU
700928         Pharmacovigilance aspects of licensing agreements
700971         Getting the Most Out Of Data Mining for Pharmacovigilance and Risk Management
701372         Preparation of a corrective action/preventive action plan (CAPA) in Drug Safety/Pharmacovigilance
701293         Quality Assurance and Quality Risk Management for Drug Importers
701367         Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing
               Responsibilities
700286         Drugs, Quality, and Satisfaction
701346         Why is Accurate Adverse Event Reporting essential for drug safety - How to Assess the Causality
               Relationship
700267         Common Problems and Mistakes in Method Validation in Drug development process
700183         Creating a Product Safety Program that is as Nimble as the New Product Development Program
700655         Nanotechnology: Identifying and Managing Health, Safety and Environmental Risks
700728         Safety Risk Management for the Pharmaceutical Industry
700827         Biopharmaceutical Viral Safety from Process Design through Validation
701347         What are the Investigator responsibilities in Research Involving Human Subjects: The International Conference
               on Harmonization (ICH) position
700924         Data and Safety Monitoring in Clinical Research Involving Human Subjects - When and How
700131         Improving the Quality of Pharmaceutical Product Safety Reporting through the use of Metrics
701480         Risk Assessments - Key to a Viral Safety Management Plan




!   Cleaning Validation
Course ID      Course Name

700088         Cleaning Validation Regulations for Biopharmaceuticals: Strategies for Compliance
700404         Cleanroom Design, Certification & Classification
700630         Cleanroom Operation, Maintenance and Operators
700790         Cleaning Validation - Chemical & Microbiological Aspects
700915         Pharmaceutical Cleaning Validation
700995         Designing an Effective Cleaning and Disinfection Program for Pharmaceutical, Biotech, and Medical Device
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                                                Back to Top



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701278          Sterilization as a Benchmark for Cleaning Validation and Control
701021          Validating Disinfectants for Pharmaceutical and Biotech Operations
701371          Process Simulation Runs for Aseptic Processing – what’s required, when and how to do it
701308          Keys to Successful Validation Strategies for Disinfectants
701437          Reducing Cleaning Validation Costs Using ICH Q9 and Recent FDA Guidance
701400          Cleaning Validation Swab Recovery Studies and Analysis
701402          Application of Process Analytical Technologies (PAT) for Effective Cleaning Validation Risk Management




!   Clinical Compliance
Course ID      Course Name

700182         Implementing Clinical Trial Performance Metrics
700131         Improving the Quality of Pharmaceutical Product Safety Reporting through the use of Metrics
700230         The Importation of clinical trials materials into Europe : Tips to follow and pitfalls to avoid
700277         Orchestrating the Integration of Multiple Technical Suppliers in a Clinical Trial
700275         Establishing Effective Business Strategies for Managing Outsourced Services
701352         GLP guidelines for the Non-clinical Evaluations of Biologics
701344         How does 21 CFR Part 11 help ensure data integrity and subject safety in clinical research
701214         Clinical Trial auditing - identifying risks and building a more compliant and successful trial
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
701054         How to conduct a Clinical Trial in accordance with FDA regulations and how to avoid the common deficiencies
               observed during FDA clinical audits
700923         Investigator responsibility/Legal commitment in drug and device clinical research: the reality
700992         Organization of Clinical Datasets in eCTD Submissions
700924         Data and Safety Monitoring in Clinical Research Involving Human Subjects - When and How
700871         Monoclonal Antibodies and Therapeutic Proteins: Designing GLP Compliant Nonclinical Programs to Meet FDA
               Expectations
700853         GLP Compliance Audits: What to look out for at a New Nonclinical CRO
700864         Understanding Good Cell Culture Practices, GCCP, in Nonclinical In Vitro Safety Studies
700846         GCP Audit of Clinical Evaluations for Japan: Requirements and expectations from the revised Japanese PAL
700275         Establishing Effective Business Strategies for Managing Outsourced Services
700636         Effective Method Transfer of Complex Bioassays
700562         Designing Regulatory-Compliant Clinical Research Data Management Systems
701095         Clinical Trials Process: Study Sponsor's and Investigator's Responsibilities
701004         Risk-Based Equipment Validation
701440         FDA Clinical Trial Requirements, Regulations, Compliance and GCP (Good Clinical Practice)
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701451         How to Create and Understand A Statistical Analysis Plan for A Clinical Study
701348         The Secret of Study Conduct Documentation to ensure a successful Audit: What the FDA Inspectors looks for
701368         CROs (Clinical Research Organizations) – Identification, Selection, and Management for
               Maximum Results & Value
701386         How to Write an ICH-Compliant Clinical Study Report
701388         Understanding Attribute Acceptance Sampling including Z1.4 and c=0 Plans
701382         Clinical Statistics for Non-statisticians
701059         Transitioning Complex Cell-Based Bioassays from the Non-Regulated Lab to the GMP Test Facility: Executing a
               Successful Transfer
701265         Webinar - Computer Systems Used In Clinical Trials
701362         Internal Site Auditing for FDA Computer System Compliance
701345         What is the role of Data and Safety Monitoring in Clinical Research Involving Human Subjects - When and How?
701508         GCP and FDA Regulations with regard to Investigator Responsi
701509         Clinical Trial Regulations and GCP Compliance as they relate to Adverse Events - How to Assess and report AEs
               and SAEs
701510         Pediatric Clinical Trial Design - Ethics, Management and Regulatory Requirements



!   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
701021         Validating Disinfectants for Pharmaceutical and Biotech Operations
701186         Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing
701129         A Practical Approach to Microbial Data Deviation Investigations
701353         Failure or OOS Investigation for Sterility or Bioburden Testing
701364         Auditing the QC Microbiology Laboratory for FDA Compliance
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
701066         Quality Risk Management Using Failure Modes, Effects and Criticality Analysis
700971         Getting the Most Out Of Data Mining for Pharmacovigilance and Risk Management
701366         Cell Culture Media Filtration - Points to Consider
701376         Objectionable Microorganisms in an Aseptic Environment
701458         Strategies to establish and manage a compliant contemporary microbiology laboratory
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701443         Reduce the Risks of Foreign Material Contamination - A Manufacturer's Guide in Creating a Foreign Material
               Control Program
701396         Microbiological Risk: Do I Really Need to Test Raw Materials for Microorganisms?
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
701478         The Microbiology Lab’s Role in Contamination Control Support




!   Water System Compliance
Course ID       Course Name

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
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




!   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
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!   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
701375          Principles of the Facility design for sterile manufacturing of Biopharmaceutical products
700700          Infection Control Commissioning for Health Care Construction Projects
701397          Implementing Disposable Technologies in a GMP Facility: A case study




!   Packaging & Labeling
Course ID       Course Name

701229          Meeting FDA Requirements for Over-the-Counter / OTC Drug Labeling
701316          Security Labeling/E-Pedigree
701317          Compliance Packaging/Labeling Requirements Overview
701190          The 'New' FDA Prescription drug labeling requirements: Learn to create Prescription Drug Labeling in
                compliance with the rule and understand the essential elements'
701315          Comparability Protocols (CPs): How and when to use them for POST APPROVAL CHANGES
701089          The Coming Impact of REMS on Pharmaceutical Marketers
701335          Understanding and Preparing for System Based Inspections: Packaging and Labeling System




!   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

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                                                                                           Compliance
                                                                                           The Most Comprehensive Resource for Compliance & Quality




701336          Understanding and Preparing for System Based Inspections: Laboratory Control System
700853          GLP Compliance Audits: What to look out for at a New Nonclinical CRO
701352          GLP guidelines for the Non-clinical Evaluations of Biologics
701340          Development and Validation of Dissolution Procedures
701364          Auditing the QC Microbiology Laboratory for FDA Compliance
701325         Auditing Analytical Laboratories for FDA Compliance
701333         Understanding and Preparing for System Based Inspections: Materials System
701334         Understanding and Preparing for System Based Inspections: Production System
701458         Strategies to establish and manage a compliant contemporary microbiology laboratory
701411          Out-of-Specification Investigations, Identifying the Attributable cause or Laboratory Error
701419         Proficiency Testing: How to Pass with Flying Colors and What to Do If You Don't
701513         Quality Practices for R&D CMC Laboratories
701439         Laboratory Investigations Relating to Sample Re-Analysis: Covering the basics before being called out




!   Marketing / Sales
Course ID       Course Name

701062          Understanding the Pharmaceutical Supply Chain in China Risks, Rewards, Solutions
701189          Auditing and Qualifying Suppliers and Vendors – An Effective Risk Based Approach
701207          Delivering Biopharmaceutical Facilities in a Risk Based World: The Role of GEP, QbD, and E2500




!   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
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