Data Integrity & Computer System Validation 2 Day Workshop 2017

Overview

Data Integrity continues to attract increasing attention of worldwide regulatory agencies. Although the need for data integrity has been in existence for a long time, it is only recently that it has received the focused attention of regulators.

While regulatory agencies are hiring computer savvy personnel to boost their data integrity audit staff, business expediency requires pharmaceutical management to also seek Data integrity training from qualified and experienced trainers with a track record of successfully designing, implementing and obtaining “fit for use certification for systems that fulfil data integrity requirements

CHINMOY ROY is one such person with a successful record of accomplishment for implementing data integrity on large systems in the pharmaceutical industry in the US. He has also established data integrity business processes at several companies in the US. During his training, he uses specific case studies from his personal experiences. These case studies demonstrate the fine nuances of Data Integrity. His US trainings that we have sponsored for the past 2 years have been full to capacity. We have received excellent feedback from his trainings in the US that we sponsored for the past two years. After success in the US We are glad to bring this training from the US.

Speaker

Meet with greaters

Chinmoy Roy

BSEE, MSCS

US FDA Expert
Data integrity & CSV

Subject Matter Expert: Data Integrity, GAMP, CSV, CFR 21 Part 11, Annex 11, Quality Risk Management, Manufacturing Process Automation and IT systems

Chinmoy Roy has 35+ years of experience. He is an internationally recognized subject matter expert in CSV, CFR 21 Part 11, Annex 11, Data Integrity and manufacturing process automation systems. He has been invited to speak and conduct training workshops at several international conferences such as ISPE, WBF, Shimadzu’s annual conference for Asia Pacific, etc.

His expertise stems from his experience in implementing and obtaining “fit for use” certification for over 200 IT systems. He has worked at and consulted with leading US based companies such as Roche, Genentech, Bayer, Novartis, Johnson and Johnson etc. His pioneering efforts in implementing CFR 21 Part 11 compliant manufacturing IT systems in 1999 while employed by Genentech, was a precursor to FDA’s issuance of Part 11’s Scope and Application guidance in 2003. His workshops are unique in that he blends his field experience to provide case studies to explain the intricacies of implementing regulations. Chinmoy is an Electrical Engineer and a Computer Science post graduate.

Key Benefits

What's going on there come and learn

World Compliance Seminars (WCS) is known all over the world for high quality of professional training programs it offers to members of the global biopharmaceutical community. While WCS has been mainly focussed in the US and European markets in the past, it is now bringing its highly popular and well-attended training on Data Integrity to India.

Key Topics

Turn ideas into action

The 2 Day Conference and workshop will be mix of presentations, hands-on practical sessions, interactive workshops, case studies and Q/A sessions. Participants are encouraged to put forward their questions at the conference; these will be answered and discussed during the workshop.

  Day one

  • What is Data Integrity?
  • Primer on Part 11 and CSV
  • Group exercise: Mapping DI to Part 11
  • Why Data integrity issues occur
  • Take back to work - How to implement a DI program

  Day Two

  • Data Integrity in the Laboratory
  • Group exercise: Develop a Audit Trail design and Audit trail review SOP
  • How to validate Data Integrity
  • How is Data Integrity audited

Register T0 Data Integrity Audit Seminar 2017 Now!

Learning Objective

Be a guest

  Why should you attend?

  • What is the exact meaning of Data Integrity (DI)
  • How does it differ from regulatory agency’s’ definition
  • What is the difference between 21 CFR Part 11 and DI
  • What are the specifics of DI issues?
  • DI guidance from various regulatory agencies
  • What regulators look for during DI audits
  • How to respond to DI issues
  • DI issues with paper and hybrid records
  • What DI documents do regulators expect to see
  • What should the contents of these documents be?
  • How to validate for DI

  Who should attend?

Companies who should Attend:
  • Pharmaceutical Companies
  • Medical Device Companies
  • Biotech Companies
  • Laboratories Companies
  • Quality Departments of API Manufacturers
  • Quality Departments of Finished Product Manufacturers
  • Contract Laboratories
  • Clinical Research Organizations

 

Departments who need to Attend :
  • Regulatory Affairs
  • Training Departments
  • Documentation Departments
  • Quality Control & Quality Assurance
  • Validation
  • Laboratory Departments
  • Research & Development
  • IT/IS Departments
  • Software Development
  • Production
  • Manufacturing
  • Clinical Trials sponsors and conductors

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Location

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