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.
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.
We have all heard of Computer Systems Validation & 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:
- 21 CFR Part 11 and Computer Validation: Why so many citations?
- Computer Systems Validation (CSV) and 21 CFR 11 vs Annex 11
- Data Integrity vs Computer Systems Validation
- Overview and Key Requirements of Part 11 & CSV
- How to use a Risk Based Assessment to reduce work while still achieving Compliance?
- How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity?
Why you should 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.
Who Will Benefit
- 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 Development
- Directors / Senior Directors of Commercialization
- Document Managers
- Training Managers
- Data Managers
- Safety Managers
- What is 21 CFR 11/Annex 11 and Computer Systems Validation and how is it implemented?
- How to use Risk Based Assessments to reduce work while still achieving Data Integrity and Compliance?
- Validation Master Plan
- Complete Validation for a System (software development lifecycle)
- Equipment Qualification
- Infrastructure Requirements
is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.
Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer,Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA Patent on speeding up software compliance https://www.google.com/patents/US8266578
Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom includes training 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 LifeSciences.