The Center for Professional Innovation & Education, Malvern, PA
11/17/08
Who Should Attend
This course was developed for those employees in the pharmaceutical industry who are involved with ensuring regulatory compliance for drugs and biologics. Typical attendees include those in: - Manufacturing/Production
- Regulatory Affairs
- Research and Development
- Quality Assurance & Control
- Development and Preparation of Submission Material
- Laboratory Operations
This course is designed for individuals who require an in-depth knowledge of regulatory affairs and compliance issues. The content is continually updated by our expert Course Directors.
When delivered as an in-house program, this course is fully customizable to meet the specific needs of an organization, department or employees functional responsibility.
Learning Objectives
This course will provide each attendee with the background and knowledge necessary to understand the organization, structure and role of the FDA as it relates to compliance issues dealing with drug and biotech products. The course content is designed to provide an in-depth understanding of how the FDA performs inspections, the type of information they are looking to see in place and the variety of results that can occur from each inspection. The course also covers the remedies available to satisfy the FDA that processes and guidelines are fully in compliance.
Course Description
As with all CfPIE courses, our expert Course Directors regularly update the content of the course to reflect the latest FDA actions and compliance strategies. This course discusses the role played by the FDA, it's administrative and enforcement powers, its strategies towards compliance issues and how these affect operations within pharmaceutical, biotech and related industries. Issues to be covered include:- Structure of the FDA
- FDA Inspections
- Documentation
- The scope of FDA disciplinary actions
- How to develop and maintain strict compliance including:
- Policy guidelines
- Good CGMP practices
- Development of a standard compliance program - Hosting an FDA Inspection
- Communication with the FDA
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