Key Take Away :
This webinar will provide a clear understanding of the basics of GLP and cGMP compliance in drug development (non-clinical testing, and manufacturing of drugs).
Overview :
Get a comprehensive overview of the key compliance regulations required for GLP laboratory compliance for non-clinical testing in drug development. And, also a comprehensive overview of the cGMP regulations for the manufacturing in pharmaceutical development.
Why Should You Attend :
No FUDs are expected. Compliance based on the regulations are well established, and documented in key guidance documents. Any personnel working in these areas must adhere to the regulations. It is “black and white”, and straightforward.
Areas Covered In This Webinar :
Historical background
Applicable guidance’s and regulations
Case Studies
Learning Objectives :
Requirements at each level; testing laboratory, manufacturing facility, animal facility, CRMs, key reagents, labelling, SOPs, documentation
Preparing for audits
Penalties for non-c
Scientists
Analysts
Technicians
Supervisors
Laboratory Directors
ompliance
Who Will Benefit :
Scientists,
Analysts,
Technicians,
Supervisors,
Laboratory Directors
For more information, please visit : https://www.atozcompliance.com/trainings-webinar/life-sciences/laboratory-compliance/understanding-fundamental-glp-compliance-for-non-clinical-product-development/chitra-edwin/300193
Email: support@atozcompliance.com
Toll Free: +1- 844-414-1400
Tel: +1-516-900-5509
Level:
Intermediate
Speakers Profile :
Chitra Edwin
Chitra Edwin, Ph.D., RAC. has extensive experience in the product development, regulatory affairs, strategy and compliance of in vitro diagnostics (IVD), medical devices and biologics (vaccines) in infectious diseases, oncology, and cardiology. She has held leadership roles in the private sector including the Cleveland HeartLab, MassBiologics, and Chiron Diagnostics. Dr. Edwin is an Adjunct Associate Professor of Pharmaceutical Sciences, College of Pharmacy, University of Cincinnati.
Dr. Edwin obtained her Ph.D. in from the University of Minnesota, and post-doctoral training at the Harvard Medical School and the Dana Farber Cancer Institute. She is Regulatory Affairs Certified (RAC). She was a Review Board member of Opus Institutional Review Board (IRB).
