Bringing FDA Pharmaceutical GMPs into the 21st Century

This presentation will review the key aspects of Pharmaceutical GMPs for the 21st Century and Quality Systems Approach to Pharmaceutical CGMP Regulations. These documents were issued by the FDA in an effort to bridge the gap between today’s environment and 1978, the date of the last major update to the FDA CGMP regulations governing drug manufacturing. The presentation will include an assessment of the potential impact of FDA’s professed new approach to regulating the pharmaceutical manufacturing sector in the 21st century.The last major update to the FDA CGMP regulations governing drug manufacturing was in 1978. This predates the advent of the Personal Computer (PC), not to mention the Internet! In an effort to bridge the gap, FDA first issued a notice under the heading, Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach, announcing its intention to carry out a systematic reappraisal of FDA’s approaches to product quality regulation. More recently, in September 2006, FDA issued a new Guidance for Industry, Quality Systems Approach to Pharmaceutical CGMP Regulations. This presentation will provide a review of the key aspects of the content of these documents and assess the potential impact of FDA's professed new approach to regulating the pharmaceutical manufacturing sector in the 21st century.

Areas Covered in the seminar:

• Background to the new guidances
• Scope and Goal
• Quality systems approach
• Risk management
• Some FDA Initiatives to date
• Potential impact of new approaches

Who Will Benefit:

This webinar will provide valuable assistance to all manufacturers of human, veterinary and biological drug products (finished pharmaceuticals), who are subject to FDA 21 CFR Parts 210 and 211. It may also be useful for manufacturers of components such as APIs used in the manufacture of these products. The employees who will benefit include:

• QA managers and personnel
• Manufacturing managers and personnel
• Quality system auditors
• Regulatory affairs
• Consultants

Instructor Profile:

Tony Dunbar, has over 30 years quality management experience in his career with Parke-Davis, Warner-Lambert, Pfizer and currently with PENSA as their Senior Compliance Consulting Expert. PENSA (www.gmps.com) provide compliance services and validation/compliance software to the Life Science Industries. In his role at PENSA, Tony has provided regulatory compliance guidance to a number of industry-leading clients, in addition to assessments and validation of various computer systems against GMP and Part 11 requirements. Tony has also been a presenter of GMP topics and Part 11 at various industry group seminars. Tony has an M.Sc. degree and is a senior member of ASQ, and a Certified Quality Auditor (CQA).

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