FDA's New Enforcement of 21 CFR Part 11 - Webinar By GlobalCompliancePanel 2011
04 May 2011
Webinar
Overview: FDA`s new Part 11 regulation takes quite some time, but inspectors go out and inspect computer systems and e-records for compliance with GMPs and most recent Part11 interpretations.
Just in 2007/2009, there have been about 30 Warning Letters related to Part 11 compliance, some with disastrous consequences for inspected companies. It seems that `enforcement discretion` as stated in the 2003 guidance is not applied any more. FDA`s computer expert John Murray recommended at a conference to follow 21 CFR Part 820 also for drug companies but industry needs more guidance and practical recommendations on how to respond to FDA`s new enforcement practice.
Areas Covered in the Session:
FDA`s current inspection and enforcement practices
FDA`s new interpretation: learning from FDA guidance, and recent FDA conference presentations and discussions
Learning from FDA inspection reports
Part 11 and the new EU Annex 11: similarity and differences
Strategy for cost-effective implementation of the `new` Part 11:A six step plan
Recommended changes to existing Part 11 programs to reduce costs
Justification and documentation for the FDA and your management
15 Case studies from laboratories, offices and manufacturing with graphical workflow of records, step-by-step description, recommendations for individual Part 11 requirements with justifications and documentation for the FDA and your management.
How to prepare for Part 11 Inspections
Who Will Benefit:
IT managers and System Administrators
QA Managers and Personnel
Analysts and Lab Managers
Validation Groups
Software Developers
Validation Professionals
Training Departments
Documentation Department
Consultants
Past Events
FDA's New Enforcement of 21 CFR Part 11 - Webinar By GlobalCompliancePanel 2011 - 04 May 2011, Webinar (14926)
FDA's New Enforcement of 21 CFR Part 11 - Webinar by GlobalCompliancePanel 2010 - 06 Oct 2010, Webinar (8753)
FDA`s New Enforcement of 21 CFR Part 11 - Webinar By GlobalCompliancePanel 2026
Important
Please, check "FDA`s New Enforcement of 21 CFR Part 11 - Webinar By GlobalCompliancePanel" official website for possible changes, before making any traveling arrangements
Event Categories
Education: Training
Health & Medicine: Hospitals & Clinics, Medical device, Medical laboratories, Pharma
