Description:
This training program will provide an introduction to regulatory expectations for data integrity, discuss generation, review and archiving of data, enumerate evolving requirements for eData, and expound on support systems for data integrity.
Why Should You Attend:
Data integrity related issues are currently the focus of regulatory inspections worldwide. We have seen a sharp increase in the number of warning letters from the FDA on this topic The FDA’s April 2016 draft guidance and guidances issued by other regulatory agencies have wide implications on how raw data, both electronic and paper, is to be generated, reviewed and archived. This webinar will address the key elements of regulatory expectations for data integrity.
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Areas Covered in the Webinar:
9.00-10.00: Introduction to Regulatory Expectations for Data Integrity
- What are the new and evolving regulatory expectations
- What are the consequences of not meeting regulatory expectations for data integrity
- Overview of a ten step approach to achieving data integrity
- Q&A
10.00-10.05: Break
10.05-11.00: Generation, Review and Archiving Data
- Step 1: Generation of data
- Step 2: Review of data
- Step 3: Archiving data
- Step 4: Addressing OOS results
- Q&A
11.00- 11.05: Break
11.05 -12.00: Evolving Requirements for eData
- Step 5: QC instrument generated data
- Step 6: Data in LIMS systems
- Q&A
12.00- 12.05: Break
12.05 -1.00: Support Systems for Data Integrity
- Step 7: SOPs to support data integrity
- Step 8: Auditing to identify problem areas in data integrity
- Step 9: Training to support data integrity
- Step 10: Maintaining the culture
- Q&A
Who Will Benefit:
- QC chemists, supervisors and managers
- R&D chemists, supervisors and managers
- QA managers and personnel
- Regulatory affairs personnel
Speaker: Nanda Subbarao, Senior Consultant, Biologics Consulting Group
Dr. Subbarao, holds a Ph.D. in Bio-organic Chemistry. She is currently a Senior Consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC and GLP/GMP Quality Systems. Her hands-on industrial experience covers stability and laboratory cGMP systems for both biologics and conventional drugs. As a consultant she has assisted pharma and biotech organizations in evaluation of analytical methods and method validation for a wide range of products ranging from conventional drugs to well characterized proteins and vaccines, from pre-clinical phase to commercial phases. She has been involved several times over her career in projects to setup or upgrade cGMP/GLP complaint Quality Systems for laboratory and stability programs for products during development and in commercial phase. She serves on the AAPS Stability Focus Group Steering Committee.
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To register/enquire, please contact:
www.compliance.world
Call us at this Toll Free number: +1-866-978-0800
