Source: http://www.labcompliance.com/seminars/audio174/default.aspx
Timestamp: 2017-04-24 01:43:05
Document Index: 135262499

Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art11', 'art11']

Implementing FDA's 'New' 21 CFR Part 11
On-line Audio Seminar 174
The FDA has changed the approach and is preparing a new major revision for Part 11. The content of the new regulation is very well defined and now is a good time to learn what's coming and prepare your organization for the upcoming changes. The best way to learn about Part 11 requirements and implementation is through case studies. In this interactive seminar we will go through 10 case studies from Pharmaceutical, Biopharmaceutical and Device Industry. All are very well documented and the recommendations are justified. The case studies answer all questions that frequently come up for Part 11 implementation.
What are the key requirements of Part 11?
We already have a Part 11 program: what should we change?
How can we be sure that we do enough but not too much?
Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will present strategies and give practical recommendations. After the seminar, an extensive list of reference material like SOPs and well documented case studies with justifications will help immediate and cost effective implementation. During the interactive presentation you learn about:
FDA's current inspection and enforcement practices: a risk based approach
Existing requirements that will go away New requirements of the 'new' Part 11
10 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.
- All well documented with graphical workflow, step-by-step description, recommendations for Part 11 requirements and and justifications for the FDA and your management
- Retention and Archiving of Electronic Records Gap analysis/checklist: 21 CFR Part 11
Warning letters and Inspectional observations related to 21 CFR Part11
Recent FDA Presentation with Part11 Update