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
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
