FDA Enforcement of 21 CFR 11 Compliance

Event Information
Product Format
Prerecorded Event
90 minutes
Product Description

Understand FDA’s View of Enforcement Under Part 11 and How You Can Prepare Your Company for an Upcoming Inspection.

Through its Part 11 inspection and enforcement program, the FDA has continued with its enforcement action. 30 warning letters were issued by the FDA related to Part 11 violations in the last three years alone. Most of the citations were related to security, integrity and availability of electronic records while some were related to software and computer systems validation.

However, typically, citations are against the predicate rules, not part 11 itself. This is very confusing and makes it difficult to determine what FDA assesses in these inspections.

To get a better insight, join expert speaker Angela Bazigos in this webinar as she helps you get a better understanding of what 21 CFR 11 means and why and how it was implemented. She will also discuss FDA’s view of what is enforced under Part 11 inspections, and how you can prepare your company for the upcoming Part 11 inspection.

Session Highlights:

  • 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 and 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
  • Preparing your company for a successful part 11 inspection

Who should attend?

  • 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

Order Below or Call 1-866-458-2965 Today

You can also order through:




About Our Speaker

Angela Bazigos - Pharma Conferences

Angela Bazigos is the 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 & Public Health Services companies. Positions include Chief Compliance Officer at Morf Media, Director of QA,...   More Info
More Events By The Speaker

Why AudioEducator?
  • Save money on travel.
  • Meet your specific training needs.
  • Keep learning after the event.
  • Save time training your whole staff.
Join Our Mailing List
Our Accreditation Partners
Facebook Twitter Linkedin Youtube RSS Feeds Google Plus
Audio Educator


Dear Valued Customers


We regret to announce that ProEdTech LLC and all its affiliate brands will cease operations on April 1, 2019.


We are no longer able to fulfill online orders. We will fullfill all DVD and book orders already placed.


Customers of canceled webinars and subscription products may request a refund at (800) 223-8720 or service@proedtech.com. You must do so by April 1, 2019.


Thank you for your business and loyalty over the years. We sincerely apologize for any inconvenience caused.


Best regards,

The ProEdTech Team