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Developing a Strategy for Testing Raw Materials in a GMP Environment

June 2, 2020 @ 10:30 am - 12:30 pm

Live, Interactive Training Webinar

Developing an Effective Strategy for Testing Raw Materials in Phase 1 Through Phase 3 Environment

Risk Management of Raw Materials in a GMP Environment  

Date: Tuesday June 2, 2020
Time: 10:30 AM – 12:30 PM Eastern (New York Time)
Instructor: Barry A. Friedman Ph.D.

This live training webinar will examine a variety of issues surrounding raw materials. Depending on the product being developed, e.g., tablets and capsules vs. biotechnology products, as few as fifteen to twenty raw materials or as many as sixty have to be sourced and approved before the process can be moved from initiation through completion. During this process, the risk management of raw materials in a GMP environment is an area which is often overlooked.

This live presentation will extensively review this area. It will also delve into the renewed issue of microbial contamination of these raw materials and why the FDA, EMA and Health Canada have recently focused on this.

The webinar will also focus on what materials should be tested and to what extent during Phase 1, 2 and 3. It will cover testing requirements during each Phase and what may be optional until the product moves to its next Phase.

The main objective of this interactive webinar is to explore raw materials in a cGMP environment, their requirements and how they may affect the timeline of meeting the launch date of a product.

Webinar outline and time breakdown:

Time*

10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Definitions,
Developing an Overall Strategy,
Testing as a Strategy(FDA Considerations),
(Other Considerations),
11:30 AM Break
11:40 AM Issues Associated with Raw Materials,
Quality Control Review,
Warning Letters – Raw Materials,
12:30 PM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

 

For more info please visit: https://www.pharmawebinars.com/raw-materials-in-gmp-environment-requirements

To register please visit: https://www.pharmawebinars.com/registration-form/

 

 

Details

Date:
June 2, 2020
Time:
10:30 am - 12:30 pm
Website:
https://www.pharmawebinars.com/raw-materials-in-gmp-environment-requirements