Understanding and Preparing for FDA's New Part 11 Inspection Program 2010
24 Sep 2010
Webinar
This Part 11 Inspection training will answer all questions related to the new part 11 inspection program by FDA and FDA expectation of implementing part 11 requirements.Areas Covered in the Seminar:
FDA inspections: Preparation, conducts, follow up.
Scope of the new Part 11 program: time frame, expected outcome.
Criteria for selection of target companies.
What will inspectors be looking for.
How to prepare your company for the upcoming inspections.
Learning from previous inspections with focus on Part 11 and computer validation: most frequently cited deviations.
How to fill gaps short term.
Developing a program for long term.
Creating the right documentation to satisfy the inspectors.
Most likely next steps after the inspection program.
Hand-Outs:
For easy implementation, attendees will receive
Part 11 Checklist
Part 11 Compliance Master Plan
Case Studies
How to avoid Part 11 related 483`s and Warning Letters
How to respond to Part 11 related 483`s and Warning Letters
30 FDA Warning Letters from 2007 to 2010 (Web downloads) with deviations related to computer systems and Part 11 compliance.
Past Events
Understanding and Preparing for FDA's New Part 11 Inspection Program 2010 - 24 Sep 2010, Webinar (8643)
Understanding and Preparing for FDA`s New Part 11 Inspection Program 2026
Important
Please, check "Understanding and Preparing for FDA`s New Part 11 Inspection Program" official website for possible changes, before making any traveling arrangements
Event Categories
Business: Quality assurance
Education: Training
Health & Medicine: Medical device, Medical laboratories, Pharma
