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Recorded Webinar
Understanding FDA Guidance on GLP for Nonclinical Laboratory Studies
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Dr. Syed Shahabuddin, Ph.D., FAAAAI
Senior Consultant, Drug Development
PristinePharma, LLC
Short Abstract
The FDA Guidance on Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies as described in Title 21, Part 58 of the Code of Federal Regulations, provides the framework for how to conduct a preclinical study if one is intending to submit an application to FDA for marketing permits of FDA regulated products, for example, submission of new drug application (NDA). GLP covers topics like who coordinates the study, who does the study, how are the materials, animals, and facilities maintained, how is the data organized and stored, how are the reports written, who checks the report, and what federal inspectors are looking for before and after the study is submitted to the FDA.
There is no formal certification in GLP. One can demonstrate the knowledge of GLP by completing a training course or a workshop, but one can equally demonstrate understanding of GLP by self-educating the key concepts and their applications. This webinar will provide a simplified overview of the GLP regulations, providing an understanding of not only what they are, but how the components fit together in conducting an FDA compliant non-clinical laboratory study.
The presentation will cover all the Subpart of Title 21, Part 58 including the follow topics:
- FDA and International GLP regulations: 21 CFR Part 58
- Objectives and concepts of GLP
- Organization and Personnel: Management, study director, QA, and analysts.
- Facilities: Key requirements for animal care, laboratory operation, specimen and data storage, equipment, and test and reference articles
- Protocols for conduct of laboratory study
- Records and Reporting: format and archiving
- FDA inspections
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