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VALIDATION AND 21 CFR PART 11 COMPLIANCE OF COMPUTER SYSTEMS -USFDA India Seminar 2011 at Mumbai

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VALIDATION AND 21 CFR PART 11 COMPLIANCE OF COMPUTER SYSTEMS -USFDA India Seminar 2011 at Mumbai Powered By Docstoc
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            USFDA India Seminar 2011 at Mumbai
            VALIDATION AND 21 CFR
            PART 11 COMPLIANCE OF
            COMPUTER SYSTEMS
            by   Dr.Ludwig Huber
           On 15th and 16th September , 2011 at Renaissance by J.W Marriott at Mumbai




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             USFDA India Seminar 2011 at Mumbai

                 Dr.Ludwig Huber
                 Director of Labcompliance

About Speaker:
Dr. Ludwig Huber, Ph.D., is Director for global FDA compliance at Labcompliance. He is the author and editor of
www.labcompliance.com, the on-line resource for validation and global FDA compliance. He is also the author of the
bestselling books “Validation of Computerized Analytical and Networked Systems ” and “Validation and Qualification in
Analytical Laboratories,”. Currently, Dr. Huber is on the Scientific Advisory board of IVT´s GxP and Validation Journals,
and he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This
included seminars and presentations for the US FDA, ISPE, PDA, PIC/S and several national health agencies. Dr. Huber
also received the “First International GLP Award” from Indian Drug Manufacturer Association for presentations and
publications about GLP and GMP

The concept
? time will be dedicated to workshop type exercises using prepared fill-in templates and to interactive
50 % of the
discussions

Past Seminars




                                                     Date and Venue:
                                                     September 15th and 16th, 2011
                                                     Renaissance by J.W Marriott at Mumbai
                                                     #2 & 3B, Near Chinmayanand Ashram, Powai.
                                                     Mumbai, 400 087 India
                                                     Contact number: 000 800 440 1180
                                                                       USFDA India Seminar 2011 at Mumbai

 Seminar Content:                                                                                            Conference timings: 9:00 am - 6:00 pm

 Day 1 - 15th Sept 2011                                                         Day 2 - 16th Sept 2011

 Module 1: Regulatory requirements and recommendations from Industry           Module 5: Validation and Use of Excel Spreadsheets in regulated
 Task Forces                                                                   environments
 u EU requirements for software and computer system validation
   ? FDA and                                                                   u   Regulatory requirements for spreadsheets; FDA Part 11, PIC/S Good
 u ? FDA Inspection and Enforcement Practice How does validation help to           Practice Guide. and the EU Annex 11
                                                                               u   Recommendations from the new GAMP®5
     improve your business                                                     u FDA use Excel to comply with its own regulations: going through
                                                                                   How does
 u of recent Warning Letters and 483s
   ? Examples                                                                      two FDA information bulletins
 u validation according to GAMP 5
   ? Computer                                                                  udesign spreadsheets for compliance.
                                                                                   How to
 u                                                                             u   The reduced lifecycle for cost effective validation
   ? Which systems need to be validated
                                                                               uensure and validate spreadsheet integrity.
                                                                                 ? How to
 u the right validation approach for commercial off-the-shelf system
   ? Selecting
                                                                               u   When, what and how much to test?
 u risk based validation approach to lower costs
   ? Using the                                                                 u of standard/native Excel functions?
                                                                                   Validation
 u ? Step-by-step instruction for risk assessment according to most recent     u of Excel spreadsheets and Macro programs
                                                                                   Specifics
     guidelines                                                                u   Excel spreadsheet validation from beginning to the end: A case study that
 u Exercises
   ? Workshop                                                                      can be used by everybody
 Module 2: Eight Steps for Cost Effective Computer System Validation           Module 6: Qualification of Network Infrastructure and Validation of
 u the validation team: Selecting the right members and a project
   ? Forming                                                                   Networked Systems
                                                                               uqualify infrastructure if we validate the system anyway
                                                                                   Why to
     leader                                                                    u
 u for effective implementation                                                    Recommendations from FDA and GAMP
   ? Planning                                                                  u   Configuration management and change control as the most important
 umeaningful specifications
   ? Writing                                                                       network qualification steps
 u and qualifying the right vendor using the risk based apprach
   ? Selecting                                                                 u   Qualification of PC clients, servers, data centers
 u the site for installation                                                   u how much to test with the risk based cost/benefits in mind:
                                                                                   What and
   ? Preparing
                                                                               u   Qualification of network components, servers, PC clients,
 u and testing the system for correct operation
   ? Installing                                                                u   Documentation requirements: SOP, installation and test scripts, system
 uduring on-going use: what and how
   ? Testing                                                                       diagrams, change logs
 u existing systems                                                            u   Going through a real life inspection
   ? Validating
                                                                               u internet in regulated environment
                                                                                   Using the
 u control and revalidation
   ? Change                                                                    u exercises
                                                                                   Workshop
 u exercises
   ? Workshop                                                                  Module 7. Understanding the spirit and basics of the FDA Part 11 and the
 Module 3.Initial and ongoing tests of software and computer systems           EU GMP Annex 11
 ureduce costs though risk based testing using the traceability matrix
   ? How to                                                                    u EU requirements for electronic records and signatures: similarity
                                                                                   FDA and
 u ? Justify and document what and how much to test                                and differences
                                                                               u   FDA inspection and enforcement practices of electronic records: examples
 u ? Leveraging vendor testing
                                                                                   of recent FDA warning letters
 u ? Understanding FDA warning letter phrases: testing for worst cases, high   u current status and future of Part 11 and Annex 11
                                                                                   History,
     load, limit                                                               u   The difference between electronic and digital signatures
 uCOTS systems according to GAMP V
   ? Testing                                                                   u   E-signature requirements for Annex 11 and Part 11
 u                                                                             u which systems require Part 11/Annex 11
                                                                                   Deciding
   ? Developing a test plan and protocols
                                                                               u   Define user requirements for Part11/Annex 11 based on risk
 u training documents of IT professionals and test engineers: don't
   ? Required                                                                  u   Performing a Part 11 gap analysis
     forget GMP training                                                       u old or purchasing new systems: compliance and business
                                                                                   Upgrading
 uconducting and document tests: demonstrating test evidence
   ? How to                                                                        aspects
 uand approval of test protocols
   ? Review                                                                    u for risk based implementation of Part 11/Annex 11
                                                                                   Six steps
 u deviations
   ? Handling                                                                  Module 8. Learn how to ensure and document data integrity for Part
                                                                               11/EU Annex 11 Compliance
 u exercises
   ? Workshop                                                                  u archive for hybrid systems: paper records or electronic records
                                                                                   What to
 Module 4: Minimum Validation Documentation Inspectors want to see             u   Justification and documentation your approach towards Part 11/Annex 11
 u the validation plan and validation report the most important
   ? Why are                                                                       documentation
     documents                                                                 u Definition, acquisition, maintenance and archiving
                                                                                   Raw data:
 u agreement                                                                   u data security and integrity
                                                                                   Defending
   ? Supplier
                                                                               u the most important function to demonstrate data integrity
                                                                                   Audit trail:
 u assessment reports
   ? Supplier                                                                  u   FDA expects to review audit trails: who, what, how many times
 u control procedures and change control logs
   ? Change                                                                    u we must keep e-records after print out: 5 eye opening case
                                                                                   When do
 u and archiving strategy
   ? Back-up                                                                       studies
 u and review of computer systems                                              u computer systems for Part 11/Annex 11 compliance
                                                                                   Auditing
   ? Evaluation
                                                                               u   ‘Must’ documents you must have for FDA/EMA Part 11/Annex 11
 u audit records versus reviews
   ? Internal                                                                      inspections
 u ? Contingency Plan                                                          u   Going through model case studies
 u recovery plan
   ? Disaster                                                                  u exercises
                                                                                   Workshop
                                                                               u   Final discussion and wrap-up
 u validation costs by using easy to understand and use fill-in blank
   ? Reduce
     validation documents
 u ? Going through examples and fill-in templates


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                                                               USFDA India Seminar 2011 at Mumbai

What you get:
                                                                                             What you pay:
1. Learning Objectives
2. Participation certificates                                                                1. Price for One Delegate pass – INR
3. Interactive sessions with the US expert                                                     16000 + 10.3% tax
4. Post event email assistance to your queries.                                              2. Early bird price for one Delegate pass –
5. Special price on future purchase of web based trainings.                                    INR 14000 + 10.3% tax
6. Special price on future consulting or expertise services.                                 3. Group Delegate pass (5 & above) – 10%
7. Special price on future seminars by GlobalCompliancePanel.                                  discount on total amount.
8. Seminar Kit – includes presentation handout, ID card, brochure, trainings catalog,
   notepad and pen.                                                                          Professionals who will benefit:
9. Networking with industry's top notch professionals                                        Directors
                                                                                             ?
                                                                                             IT/IS managers and system administrators
                                                                                             ?
                       Companies that will benefit:                                          QA managers and personnel
                                                                                             ?
                       Pharmaceutical development and manufacturing
                       ?                                                                     QC and Lab
                                                                                             ? managers
                       Active pharmaceutical Ingredients Industry
                       ?                                                                     Validation
                                                                                             ? specialists
                       ? providers
                       IT/IS Service                                                         Software
                                                                                             ? developers
                       Contract laboratories
                       ?                                                                     Regulatory
                                                                                             ? affairs
                       Medical device companies
                       ?                                                                     Training
                                                                                             ?departments
                       CROs
                       ?                                                                     Documentation department
                                                                                             ?
                       CMOs
                       ?                                                                     Consultants
                                                                                             ?


How to Register:
Step 1 : Download the registration form from GlobalCompliancePanel website.
Step 2 : Fill in the requested information and fax us or email a scanned copy of the same.
Step 3 : Send us the cheque with the purchase document which comes with the registration form.
Step 4 : We will send you a confirmation letter within 1 week after we receive the check.
Step 5 : Bring the confirmation letter with you on the 1st day of the seminar and submit it at the registration counter to receive your
         seminar kit and join the seminar.


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                                                                                                   Ren aissanc       bai
  Contact Information:                                                                                       at Mum
                                                                                                                   call us!
                                                                                                           please
  Ask for Suraj
  Coordinator – India Seminar
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  +91 80-3221-3341.
  Email: customersupport@globalcompliancepanel.com
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DOCUMENT INFO
Description: Module 1: Regulatory requirements and recommendations from Industry Task Forces FDA and EU requirements for software and computer system validation FDA Inspection and Enforcement Practice How does validation help to improve your business u? Examples of recent Warning Letters and 483s Computer validation according to GAMP 5 Which systems need to be validated Selecting the right validation approach for commercial off-the-shelf system Using the risk based validation approach to lower costs Step-by-step instruction for risk assessment according to most recent guidelines Workshop Exercises Module 2: Eight Steps for Cost Effective Computer System Validation Forming the validation team: Selecting the right members and a project leader Planning for effective implementation Writing meaningful specifications Selecting and qualifying the right vendor using the risk based apprach Preparing the site for installation Installing and testing the system for correct operation Testing during on-going use: what and how Validating existing systems Change control and revalidation Workshop exercises