FDA Good Laboratory Practices (GLP’s)

This webinar is intended to provide guidance regarding Good Laboratory Practices (GLP) for use in pharmaceutical manufacturing and clinical trials, and for use by contract laboratories that support the regulated medical products industries.

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 specifically 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.

Areas Covered in the Session :

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 repeatability / reproducibility of lab results. There will be a detailed analysis of the applicable regulations for industry. Subject areas considered are:

  • Key Regulatory Expectations
  • GLP specifics
  • Lab Control / Systems
  • Facilities and Equipment
  • Documentation and Records
  • Control of Equipment
  • Materials Management
  • Personnel / Assignments
  • Validations
  • The Laboratory GLPs and company cGMP’s

Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Validation Departments
  • Marketing Departments
  • Documentation Departments
  • Medical products development and testing testing Teams

FDB3787

John E. Lincoln

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.

He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance