FDA Enforcement of 21 CFR 11 Compliance

Event Information
1 Day
Left To Register
Product Format
Live Webinar
Presenter(s)
Conference Date
Add to my calendar   Thu, May 25, 2017
Aired Time
1 pm ET | 12 pm CT | 11 am MT | 10 am PT
Length
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 live 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

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Angela Bazigos - Pharma Conferences

Angela Bazigos, is the Chief Compliance Officer of Morf Media. She has 40 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & Software Validation.


Ms. Bazigos is a Past President of PRCSQA, a  member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups...   More Info
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