Course Description:
The subject of Data Integrity has become an increasing concern for Regulatory Agencies worldwide. We have seen a sharp increase in the number of Warning Letters by the FDA on this topic and the majority of the laboratory related warning letters issued in 2015 focused on this topic. The FDA has issued a draft guidance in April 2016 on Data Integrity which will have wide implications on how raw data, both electronic and paper, is to be generated, reviewed and archived. This seminar addresses the key elements of Regulatory Expectations for Data Integrity. Ten steps to achieving an efficient and cGMP compliant Data System will be discussed..
Who will Benefit:
- QC chemists, supervisors and managers
- R&D chemists, supervisors and managers
- QA managers and personnel
- Regulatory affairs personnel
Seminar Fee Includes:
Course Outline:
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
- Introduction to regulatory expectations for data integrity.
- Consequences of not meeting regulatory expectations for data integrity
- A ten step approach to implementing an efficient and complaint Data System
- Generating, review and archiving GMP data
- How to address OOS results
- Data integrity and instrumentation
- LIMS systems
Meet Your Instructor
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Nanda Subbarao Senior Consultant, Biologics Consulting Group Dr. Subbarao is currently a Senior Consultant with the Biologics Consulting Group, Inc specializing in Analytical, Stability, CMC and GLP/GMP Quality Systems. She has been involved several times over her career in projects to setup new or upgrade existing cGMP/GLP Quality Systems for laboratory and stability programs during development and in commercial phase. She serves on the American Association of Pharmaceutical Sciences, Stability Focus team Steering Committee and serves on the editorial advisory board of Bioprocessing International |
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