Joshua Sharlin - SOP Teleconferences
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SOPs for Implementing a Risk-Based Approach to FDA Part 11 Compliance
-Presented by Dr. Joshua Sharlin - March 11, 2010.
Topics of the Model SOPs Provided:
- SOP #1, Risk assessment: overview and approach
- SOP #2, Risk assessment checklist use
- SOP #3, Risk assessment: Part 11 applicability
Understanding FDA's Updated Package Insert Requirements for Drugs & Biologics: An Overview, Suggested SOPs & Implementation.
-Presented by Dr. Joshua Sharlin - March 27, 2007.
Topics of the Model SOPs Provided:
- Determining When A Label Must Meet the 2006 Format (6 pages)
- Format and Organization Requirements for the 2006 Label (12 pages)
Using Available Tools For SAS Part 11 Compliance: How To Reduce Costs of SAS Installation and Maintenance
-Presented by Dr. Joshua Sharlin on November 16, 2004.
Topics of the Model SOPs Provided:
- Initial installation of SAS IQ/OQ tools (4 pages)
- Using the SAS IQ tool (4 pages)
- Using the SAS OQ tool (4 pages)