FDA’s 21 CFR Part 11 Add-On Inspections

Event Information
Product Format
Prerecorded Event
Presenter(s)
Conference Date
Tue, Jun 13, 2017
Length
90 minutes
Product Description

Status of Surveillance Inspections and Future of 21 CFR Part 11

 

In December 2010, the FDA began a project to better understand the industry’s adherence (or lack thereof) to 21 CFR Part 11. This involves add on’ surveillance inspections of the sponsors’ computer systems during the course of the FDA’s regular inspections.

This session by expert speaker Angela Bazigos will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. At the beginning of the initiative, FDA made it clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003.

In the meantime, FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations. This webinar will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.

Session Highlights:

  • What is FDA's most current thinking related to computers and electronic records?
  • What are the inspection trends?
  • What are most frequent recent citations for Part11?
  • What are the most frequent deviations for computer system validation?
  • Under which circumstances can inspectors exercise enforcement discretion?
  • How important is risk based Part11 compliance?
  • What is the best strategy for future proven Part 11 compliance?

Who Should Attend?

  • Quality managers
  • Quality engineers
  • Small business owners
  • GxP
  • Consultants
  • Quality VPs
  • IT VPs

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

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

You can also order through:
Phone

1-866-458-2965

Fax

1-919-287-2643

About Our Speaker

Angela Bazigos - Pharma Conferences

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, MIS Director....   More Info
More Events By The Speaker

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