Risk Management of Raw Materials in a GMP Environment – Developing an Effective Strategy for Testing Raw Materials in Phase 1 Through Phase 3 Environment

Live, Interactive Training Webinar

Date: Wednesday January 23, 2019
Time: 10:30 AM - 12:30 PM Eastern (New York Time)
Instructor: Barry A. Friedman Ph.D. Biography>>>

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Risk management of raw materials in a GMP environment is an area that is often overlooked as a Company develops new products. 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 need to be sourced and accepted before the process can be moved from initiation through completion. 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. It will also focus upon the revised ICH Q7 “Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients“ which was revised in September 2016.

This live training webinar will also examine a variety of the issues surrounding raw materials to include 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. It will determine what options exist -- even within a Phase 2 or Phase 3 testing framework. It will discuss compendial vs. non-compendial testing and how to respond when no method is available. The presentation will also discuss how a 90 percent vs. a 90.0 percent minimum purity analysis can delay your initiation of testing.

The live training webinar will explore the number of lots required to be tested before reduced testing might occur and why some Companies don't accept this path. It will also review the use of individual samples vs. composite samples for testing.

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

Learning Benefits:
-How to develop an overall strategy for testing raw materials in Phase 1 through Phase 3 environment.
-What raw material testing is required during various Phases of clinical trials.
-What your Certificate of Analysis may tell you.
-How to manage non-compendial testing.
-Issues with small vs. large molecules.
-Types of raw materials and their concerns to the user.
-Impact of raw materials receipt in the timely production of a product.
-Review of validation criteria and recommendations for satisfying each as part of a microbiological validation.
-What is the single largest used raw material in large molecule production.
-Sources of analyses assistance for raw materials.
-Initiation of additional testing -- when???.
-Observe Warning Letters related to Raw Material issues.

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)


This live training webinar includes the following for each registered attendee:

  • A copy of the presentation slides
  • A certificate of participation for attendee training records

Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:

  • Facilities
  • Manufacturing
  • Product Development
  • Project Management
  • Quality Assurance
  • Quality Control
  • Regulatory Affairs
  • Regulatory Compliance

Registration Form ►


Instructor: Barry A. Friedman Ph.D.

Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing arena. Dr. Friedman is a frequent seminar speaker in the GMP areas of internal auditing, aseptic processing of sterile drug products, USP microbiology, validations and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He has recently given presentations for the FDA, PDA, PTi. He is a member of AAMI, ASM, PDA and RAPS. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President of the Capital Area Chapter, PDA... Full Bio>>>

 

 

Course Number: 236

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Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

"We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

"Our group enjoyed the live presentation and found the experience much more engaging and worthwhile than any recorded webcasts" Sr Training Manager, CA

"This was my first live training, I found it easy to connect, participate and very useful" Laboratory Analyst, PA

"We had our entire department attend this training program and found it to be very useful, I am very satisfied with the speaker's ability to keep the audience engaged" QC Manager, NY

"Given how recent the content of the webinar was, our team members were very happy with the relevance of the training" VP Clinical Operations, CA

"Is my first time to attend training, I enjoy it very much" Sr Manager, Korea

"Our department found the level of interactivity between the audience and the instructor far beyond that of any other online training that we have attended before. Well done" Director Regulatory Affairs, ON

"Our interest group was spread out over three locations and we were able to participate simultaneously and interact very easily" Lead Compliance Manager, IL

"Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

"We were impressed with the quality of the presentation, and despite our being located in Europe we were able to participate without a hitch" QC Manager, Ireland