Good Laboratory Practices (GLP) and USP 1058 Validation

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

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
• Validation
• The Lab GLPs and company CGMPs

Areas Covered in the Session:

• Key Regulatory Espectations
• GLP and USP Specifics
• Systems, Personel, Facilities
• Required documentation / records
• Control of equipment / test material / samples
• Laboratory Controls in the CGMPs
• Validations

Why should you attend -

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.

Who Should Attend:

• Senior management in Devices, Pharma, Combination Products
• QA / RA
• Medical products development and testing testing teams
• R&D
• Engineering
• Production
• Operations
• Marketing
• Consultants; others tasked with mnedical product development, manufacturing, logistics and V&V responsibilities

Target Audience to market:-

Management, staff, operators in Pharma, Dietary Supplements, Cell Culture and Biologics -- Life Scieince Industries.

Speaker/Presenter:-

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 41 years experience in U.S. FDA-regulated industries, 27 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 including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. 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 ptublished numerous articles in peer reviewed journals, chapters in books including RAPS (4 chapters), conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA.

After Registration:

After registering, you'll receive a confirmation email with your unique login details and access to presentation materials. All documents are downloadable and ideal for team training or reference.

System Requirements:

Internet: A strong connection (1 MBPS or higher) ensures uninterrupted access.

Audio: A good quality speaker or headset with a microphone is suggested for the best experience.

Session Cancellation Policy:

Should the Scale need to cancel or reschedule a session, all registered participants will be informed by email at least 24 hours prior to the scheduled start.

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