We have all heard of Data Integrity but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture?
Specifically, can you answer questions on the following:
- Evolution of 21 CFR Part 11 and Annex 11 and Why they are Back in the News
- Overview and Key Requirements of Part 11 & Annex 11
- How to use a Risk Based Assessment to reduce work while still achieving Data Integrity and Compliance?
- How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity?
I often refer to 21 CFR 11 and Annex 11 as Good Software Engineering with the Documentation on Steroids! However, unless one knows how to implement Data Integrity, it is often very hard to apply requirements for DATA INTEGRITY to computerized system, and very hard to determine what needs to be done, to meet domestic and/or international regulations or business continuity requirements. In addition, the agencies have stepped up data integrity inspections and the number of citations on the subject are skyrocketing!
This course is appropriate for beginner and experienced person alike. The topics will build on each other and will give you the latest trends in our heavily regulated industry and how to make it easy for yourself while still achieving data integrity.
This is a very hands-on class and the attendees will be given take away templates that will enable them to build a complete package to meet Data Integrity Requirements for Computerized Systems
Why should you Attend: This course will provide the attendees with more detailed experience on validation/ 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation.
Areas Covered in the Session:
- Introduction & Background
- Definitions
- Key Concepts
- Regulatory Focus
- Data Integrity Requirements
- Quality Risk Management
- Process Risk Management
- Quality Risk Management
- Product and Process Context
- Data LifeCycle
- Data Creation
- Data Processing
- Data Review, Reporting and Use
- Data Retention & Retrieval
- Data Destruction
- Data Integrity Management
- Corporate Data Integrity Program
- Human Factors
- Inspection Readiness
- Auditing & Audit Trails
- Data Audit Trail
- Audit Trail Review
- Data Auditing
- Periodic Review
- Data Conversions
- Retention, Archiving & Migration
- Paper Records & Hybrid Situations
- Converting Electronic to Alternative Format or Alternative Format Hybrids
- Final Thoughts
- Bad Data vs Good Data
- Causes of Poor Data Quality
- Data Integrity Roadmap
- Conclusion
- Q&A
Speakers
Ms Angela Bazigos,
CEO ,
Touchstone Technologies Silicon ValleyAngela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for Life Sciences.
Who Should Attend
- VP of IT
- Director of IT
- Quality Managers
- Project Managers (for DATA INTEGRITY / IT)
- Validation Specialists
- Database Administrators
- System Administrators
- Directors / Senior Directors of Discovery
- Directors / Senior Directors of De
