Webinar Details:

Periodically one hears the comment that “a laboratory or a manufacturing facility meets 21 CFR Part 58 Good Laboratory Practices (GLP) 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 does 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 Practices (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. They fall within the requirements of 21 CFR Parts 210/211 and support final product requirements for humans and animals.

Good Laboratory Practices 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, interactive ECC training webinar will be to explore Good Laboratory Practices (GLP) and contrast them against Good Manufacturing Practices (GMP). Please plan to bring a cross-sectional team to this Webinar to explore how these issues may assist you in your facilities.

By attending you will learn about the following:

-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).

Personnel who should consider attending include:

• Validation
• Manufacturing
• Engineering
• Quality Assurance
• Quality Control
• Metrology
• Research & Development
• Project Management

Fee:
$385 for one person
$700 2-5 people
$999 6-10 people