Good Laboratory Practices (GLP) – Comparing and Contrasting with Good Manufacturing Practices (GMP)
Live, Interactive Training Webinar
Date: Tuesday January 28, 2020
Time: 10:30am - 12:30pm ET (New York Time)
Instructor: Barry A. Friedman Ph.D. Biography>>>
Date: Tuesday January 28, 2020
Periodically one hears the comment that “a laboratory or a manufacturing facility meets 21 CFR Part 58 and therefore they meet all of the cGMP requirements”. Contrary to popular belief, 21 CFR Part 58 is not the equivalent of 21 CFR 210/211 and do not meet the same requirements as 210/211. They (Part 58) do have the force of law and are not “watered down” GMPs.
Good Manufacturing Practice (cGMPs) represents that part of Quality Assurance that ensures that products are consistently produced and controlled to the Quality standard appropriate to their intended use and as required by the product specification.
Non-clinical laboratory studies (58.1) support or are intended to support application for research or marketing permits for the following products to include:
• Food and color additives
• Human and animal drugs
• Medical devices for human use
• Biological Products
• Electronic Products
GLPs do not include manufacturing product. Non-clinical Laboratory Studies (58.3) include in vitro or in vivo experiments in which test articles are studied prospectively in test systems under laboratory conditions to determine their safety. This does not include studies utilizing human subjects or clinical studies or field trials in animals.
The Objective of this live training webinar will be to explore Good Laboratory Practice (GLP) and contrast it against Good Manufacturing Practice. Please plan to bring a team to this Webinar to explore how these issues may assist you in your facilities.
-Gain insight into “Good Laboratory Practices” (21 CFR Part 58) -Learn what GLPs are and are not. -Understand the Basic Elements of GLP. -Learn about Management Responsibilities and “Sponsors”. -Understand the Quality Assurance Unit Responsibilities -Understand the Purpose of the Study Protocol and its Importance in Conducting Acceptable Studies. -Determine the Elements of a Final Report and Why they are Important. -Compare and Contrast all of the above GLP Elements with Good Manufacturing Practice (GMP).
Webinar outline and time breakdown:
|10:15 AM||Log In Period|
|10:40 AM||Overview of “Good Laboratory Practices” (GLP),|
|Gain Insight into 21 CFR Part 58 (GLP),|
|Learn what GLPs are and are not,|
|Management Responsibilities and “Sponsors”,|
|11:40 AM||Understanding the Quality Assurance Unit Responsibilities,|
|The Purpose of the Study Protocol and its Importance in Conducting Acceptable Studies,|
|The Elements of a Final Report and its Importance,|
|A Comparison of all of the GLP Issues vs. GMP,|
|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 training for attendee records
Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:
- Quality Assurance personnel
- Quality Control personnel
- Research & Development
- Regulatory Affairs Professionals
- Project Managers
- Auditing Professionals
- Microbiology Professionals
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>>>
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