This FDA compliance webinar provides FDA’s current thinking on modernizing the regulation of quality and manufacturing science through establishment of a new regulatory framework.
It also provides an 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 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
- Objectives, Fundamental and Guiding Principles
- FDA’s Risk-Based Approach
- Risk Management and Assessment
- Concepts of Quality Systems and cGMPs
- FDA Quality Inspections
- Six System Inspection Model
- FDA Expectations
Who Will Benefit:
This webinar will provide valuable assistance to pharmaceutical, device and biologics regulated companies in or transitioning into a cGMP and Quality Systems compliant environment. It is also useful as a refresher for companies that wish to stay current with FDA's expectations. The employees who will benefit include:
- Management
- Quality Units
- Production Personnel
- 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.
