4-Hr Virtual Training: Ten Steps to Data Integrity in Pharmaceutical and Biotech Labs

Instructor: Nanda Subbarao
Product ID: 704730
  • Duration: 4 hrs
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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:

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 from the FDA on this topic and the majority of the laboratory related warning letters issued in 2015 focused on this area.

The FDA issued a draft guidance in April 2016 on data integrity which when issued in final form will have wide implications on how raw data, both electronic and paper, is to be generated,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.

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

Instructor Profile:

Dr. Nanda Subbarao is currently a senior consultant with Biologics Consulting, 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 product 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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