This Pharmaceutical training will review the key aspects of Pharmaceutical GMPs for the 21st Century and Quality Systems Approach to Pharmaceutical CGMP Regulations.
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.
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
Course Provider
Tony Dunbar,
