FDA Enforcement of 21 CFR 11 Compliance

Angela Bazigos
Angela Bazigos
90 Minutes
Product Id:
6 months

More Trainings by this Expert

Price Details
$190 Recorded
$390 Corporate Recorded
Price Detail Options

FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate data integrity, security and availability of electronic records but also related to validation of software and computer systems. However, typically, citations are against the predicate rules, not part 11 itself. This is very confusing and makes it difficult to determine what the FDA is looking for in these inspections.

Why should you Attend: This webinar will ensure that attendees are able to do the following:

  • Understand what 21 CFR 11 means, why and how it was implemented
  • Understand FDA's view of what is enforced in Part 11 inspections
  • Understand how to prepare your company for Part 11 inspections

Areas Covered in the Session:
  • 21 CFR 11 then and now: a brief history of 21 CFR 11 and what it looks like today
  • Part 11 Basics
  • FDA's view of 21 CFR 11 Compliance
    • FDA Acceptance of Data: Electronic & Paper
    • Computerized systems and eData
    • Basis for Part 11 Compliance and purpose of protection and validation
    • Diverse nature of "source" and how to protect and preserve it
    • Purpose and goal of 21 CFR 11 BIMO inspection
    • Inspection of electronic records - BIMO
  • The 10 Deadly Sins that break compliance
  • Examples of 21 CFR 11 Citations
  • How to prepare your company for successful part 11 inspections

Who Will Benefit:
  • VP of IT
  • Director of IT
  • Quality Managers
  • Project Managers (for CSV / 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
  • Doctors
  • Nurses
  • Clinical Data Managers and Monitors
  • IRB
  • FDA Investigators
  • Part 11 and Annex 11 Consultants
  • Medical consultants

Speaker Profile
Angela Bazigos 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.

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