Finished Pharmaceuticals CGMPs

Description:

This webinar will evaluate the requirements for the foundational / basic Quality Management System (QMS) and how CGMP requirements further define the specifics and their implementation and documentation. The Drug CGMPs are similar to all CGMPs, but have many enhanced or unique requirements which will be highlighte in this presentation. Subject areas considered are:

• Systems, Personnel
• Buildings and Equipment
• SOPs / WIs, Documentation and Records
• Materials Management
• Production and Laboratory
• Validation
• Material Rejections / Reuse
• Post-production Issues

Why Should You Attend:

21 CFR 210 and 211 is US law for mandateded Good Manufacturing Practices for finished pharmalogical products. When a drug product is intended to be marketed in the US, it must be manufactured under the requirments of the CGMPs, 21 CFR 210 / 211. This webinar discusses the key parts of the CGMPs that applies to the manufacture of drug for use in humans. The sterilization and aseptic processing of drugs should also be performed in accordance with the CGMPs. Failure to conform and document to the CGMPs will result in Warning Letters and further remedial actions from the US FDA.

Areas Covered in the Webinar:

• The Basic QMS, as enhanced by the CGMPs

• The Drug CGMP specifics

• Systems, Personell, the Physical Plant
• If it isn't documented, it didn’t Happen
• Control of material, product, manufacturing
• Laboratory Controls (one of the uniques areas of the Drug CGMPs)
• Validations
• Material /product rejection, release

• Complaint handling and other post-production issues

• Pharmacoviligence
• Pedegrees

Who Will Benefit:

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

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 42 years experience in U.S. FDA-regulated industries, 27 of which are as an independent consultant. John has worked with global companies to resolve regulatory issues, lead validations (hardware and software) and implement QMS/RA systems. He has published numerous articles in peer reviewed journals, 5 chapters in the RAPS textbook on Validation, conducted workshops and webinars worldwide. John is a graduate of UCLA.

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