Annual Analytical Laboratory Data Integrity Training

Speaker

Instructor: Nanda Subbarao
Product ID: 705326

Location
  • Duration: 90 Min
This webinar will address the key elements of regulatory expectations for analytical laboratory data integrity. It will teach best practices to avoid 483s and warning letters issued by FDA related to data integrity issues.
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Why Should You Attend:

Data Integrity training is a key part of the annual GxP training that is required for all GxP laboratory personnel. The subject of data integrity has become an increasing focal point for regulatory agencies worldwide. We have seen a sharp increase in the number of Warning Letters by the FDA on this topic and a majority of the laboratory related Warning Letters issued in the past few years have focused on Data Integrity. The FDA has issued a draft guidance in April 2016 on Data Integrity which when finalized, will have wide implications on how raw data, both electronic and paper, is to be generated, reviewed and archived.

This webinar will begin with a discussion about the current regulations for laboratory data integrity at the data generation, data review and archival stages. The impact of the new and clarified regulatory expectations for common laboratory methods and software will be discussed. Integrity of data in LIMS systems, clarified expectation for training of personnel on data integrity and the role of data integrity audits will be discussed.

Areas Covered in the Webinar:

  • Regulations related to data integrity
  • Impact of new expectations on common laboratory methods
  • Data integrity audits in a GxP complaint laboratory
  • 483s related to data integrity issues and how to avoid them
  • Common pit-falls that lead to 483s

Who Will Benefit:

  • QC Laboratory Staff
  • QC Supervisors and Managers
  • QA Management
  • Documentation Management Specialists
  • Regulatory Affairs Personnel
  • R&D Lab Personnel
Instructor Profile:
Nanda Subbarao

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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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

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