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21 CFR 58 - Good Laboratory Practice (GLP) and USP 1058 Validations

Duration : 90 Minutes

John E. Lincoln,

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 38 years experience in U.S. FDA-regulated industries, 24 as an independent consultant. John has worked with companies from start-up to Fortune 100, world wide.  He specializes in quality assuranc Read more

The Good Laboratory Practice regulations describe the minimal standards for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by FDA or EPA such as animal food additives, human and animal drugs, medical devices for human use, biological products, electronic products, or pesticide products. The regulations do not pertain to studies utilizing human subjects or clinical studies for which the current Good Clinical Practice (cGCP) standards would apply, although they support the GCPs. While the GLPs do not specificall pertain to basic exploratory studies carried out to determine whether a test article has any potential utility or, for FDA studies only, to determine physical or chemical characteristics of a test article, adherence to their principles will further ensure the accuracy of any results achieved. The related USP 1058 provides recommended practices for the validation of lab equipment and analytical methods.

Course Objectives:

This webinar will define what are the US FDA's expectation for proper laboratory practices, systems, equipment usage, and documentation / record-keeping..  It will evaluate the requirements for how  basic Quality Management System (QMS) expectations / requirements are addressed in the lab environment.  The webinar with evaluate pharma GMPs and 21 CFR 58 and associated regulations to see how the GLP's can be implemented in the real world to achieve FDA requirements and ensure the accuracy and repeatibility / reproducibility of lab results.  It will further consider the USP 1058 requirements for lab equipment and analytic methods validations. There will be a detailed analysis of the applicalbe regulations for industry. Subject areas considered are:

Lab Control / Systems

Facilities and Equipment

Documentation and Records

Materials Management

Personnel / Assignments


The Lab GLPs and company CGMPs

Course Outline:

• GLP specifics 

• Systems, Personell, Facilities 

• Required documentation / records

• Control of equipment / test  material / samples 

• Laboratory Controls in the CGMPs

• Validations

What You Get:

• Training Materials

• Live Q&A Session with our Expert

• Participation Certificate

• Access to Signup Community (Optional)

• Reward Points

Who Will Benefit:

• Senior management in Devices, Pharma, Combination Products

• QA / RA

• Medical products development and testing teams

• R&D

• Engineering

• Production

• Operations

• Marketing

• Consultants; others tasked with medical product development, manufacturing, logistics  and V&V responsibilities

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

Contact Us

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