FDA's cGMPs for the 21st Century Initiative
Instructor:
Betty Jones
Product ID: 700620
In 2002, FDA announced a significant new initiative; Current Good Manufacturing Practices (cGMPs) for the 21st Century intended to modernize FDA’s regulation of pharmaceutical quality and established a new regulatory framework for manufacturing science. This presentation will provide and insiders view FDA’s path to restructuring its regulatory oversight of manufacturing quality that is based on quality systems and risk management approaches. Implementation of the envisioned new framework and its elements require the use of risk-based and science-based approaches for regulatory decision-making throughout the entire life cycle of the product.
Areas Covered in the seminar:- Background and Scope
- Fundamental Principle
- Objectives and Guiding Principles
- Concepts of Quality Systems and cGMPs
- cGMP and Quality Systems Comparison
- Achieving cGMP Compliance
Who Will Benefit:
This webinar will provide valuable assistance to pharmaceutical, device and biologics regulated companies in or transitioning into a cGMP environment. It is also useful as a refresher for companies that wish to stay current with cGMP regulations and FDA’s expectations. The employees who will benefit include:
- Management
- Quality Units
- Auditors
- Quality Systems Personnel
- Consultants
Instructor Profile:
Betty Jones, MPH, is Founder/Managing Director of Comprehensive Compliance Solutions (CCS), a consulting firm specializing in all aspects of regulatory compliance and training to firms that manufacture and market FDA regulated products. Ms. Jones, the former Deputy Director of the Office of Compliance, CDER is a recognized expert in applying and interpreting FDA’s statutes, codes, regulations and standards. She has over 33 years of experience with the FDA directing regulatory and compliance activities in three of FDA’s six components and has experience as a field investigator/inspector, a compliance officer, Branch Chief and Acting Director of the Office of Compliance in the Center for Drug Evaluation and Research.
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