Preapproval Inspection and Submission to the FDA

Description:

This webinar will evaluate the key requirements of the FDA Drug and Device PMA preapproval inspection and submission program - the review of a company's CGMP system, 21 CFR 210 and 211 (drugs) or 820 (devices) for compliance. The goal of a pre-approval inspection is to ensure the FDA that the methods used in, and the facilities and controls used for, the manufacture, processing, packing, and testing of the drug are found adequate to ensure and preserve its identity, strength, quality, and purity, or the device in safety and performance (effectiveness).

Subject areas considered are:

• Systems, Personnel, Buildings and Equipment
• SOPs / WIs, Documentation and Records
• The company's existing standing and history with the FDA
• Production and Laboratory
• Validation
• Material Rejections / Reuse
• Post-production Issues

Why Should You Attend:

When a drug product is intended to be marketed in the US, it must be manufactured under the requirements of the CGMPs, 21 CFR 210 / 211. Devices are cleared under the 510((k) process for Class II and PMA approval process for Class III. This webinar discusses the FDA program used to approve the NDA, ANDA, or a class III device submission from a company only after their methods used in, and the facilities and controls used for, the manufacture, processing, packing, and testing of the drug or device are found adequate through FDA preapproval inspection to ensure and preserve the proposed product's identity, strength, quality, and purity or safety or performance characteristics. Before submission approval, FDA evaluates the establishments by on-site inspections and/or by establishment file review. That evaluation focuses on several key areas of the CGMPs for pharmaceuticals and devices. This webinar will discuss the FDA's use of their preapproval inspection program and its effect on a company's drug or device submission.

Areas Covered in the Webinar:

Participants will learn how an effective packaging installation and qualification is planned, executed, and documented. Also how it is effectively based n the critical requirement of a risk-based approach to compliance and personnel and product safety.

• The Basic QMS issues, as enhanced by theDrug CGMPs
• Documentation
• Systems, Personel, the Physical Plant
• Facility risk
• Product risk
• Process risk
• When performed?
• Other "triggers"
• Pharmacovigilance and post-market surveillance
• The preapproval team
• Objectives and Outcomes

Who Will Benefit:

• Senior management in Pharma
• 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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