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
View Course Agenda
Past Participant's Comments:
“This was and excellent class! The information gives you a very comprehensive overview of what the FDA requires. I was able to get more information from this FDA training class in two days than I have in all other training courses I have taken combined!"
Cory D., Associate Manager, Document Control, Cardinal Health – Oral Technologies
“The Course Director referred us to a lot of information available on the FDA website. This will be very helpful for future reference."
Maryann C., Scientist, Supernus Pharmaceuticals, Inc.
“Very informative course. The Course Director takes the time to answer client-specific questions which really helps drive the information home."
Claudia B., Senior Consultant, Tunnell Consulting
“Good introduction to FDA Inspection Process and requirements from all perspectives. The Course Director's experience and knowledge is very applicable and evident."
Scott G., Senior Scientist, Shire Labs
"The Course was well organized and supported well by the written material. The instructor was knowledgeable and illustrated numerous points by example. She appeared to be current on FDA thinking."
William M., Livestock Vet. Manager, Pfizer Animal Health
"Presentation was clear and the Course Director showed a willingness to go beyond the material by giving real-life examples to help with understanding and clarification."
Monica S., Senior QA Auditor, Merck
"The Course Director was very informative and the examples and personal experience used in her discussions really enhanced my learning and understanding of the topics."
Kelli H., QA Manager, PharmaForm
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