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.
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
- Quality Systems
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
Course Provider
Betty Jones,
