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 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.
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.
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:
- FDA’s cGMPs for the 21st Century Initiative
- Background and Scope
- Fundamental Principle
- Objectives and Guiding Principles
- Concepts of Quality Systems and cGMPs
- cGMP and Quality Systems Comparisons
- cGMP Compliance
- Questions
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 (Quality Control/Quality Assurance)
- Production Personnel
- Internal Auditors
- Quality Systems Personnel
- Consultants
Course Provider
Betty Jones,
