Understanding Fundamental GLP Compliance For Non-Clinical Product Development

Speaker: Chitra Edwin - Consultant,Biotechnology Consulting Solutions

Date: December 8th Thursday

Time: 01:00 PM EST | 10:00 AM PST

Duration: 60 Minutes

Product Code: 300193

Level: Intermediate

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, labeling, SOPs, documentation

·         Preparing for audits

·         Penalties for non-c

·         Scientists

·         Analysts

·         Technicians

·         Supervisors

·         Laboratory Directors

·         Compliance

Who Will Benefit

·         Scientists

·         Analysts

·         Technicians

·         Supervisors

·         Laboratory Directors

Speakers Profile

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).

Source Link:  https://www.atozcompliance.com/trainings-webinar/life-sciences/laboratory-compliance/understanding-fundamental-glp-compliance-for-non-clinical-product-development/chitra-edwin/300193