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 Participants' Comments:
"CfPIE has once again delivered a course of the highest standard. The instructor relayed her best knowledge of the pharmaceutical and biotech industries in a comprehensive and energetic manner. I look forward to attending further courses with CfPIE in the future."
Janet P., QCT, Pfizer
"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
"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
"Great introduction to the 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 very 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. Her ability to give examples based on personal experience really enhanced my learning and understanding of the topics."
Kelli H., QA Manager, PharmaForm
"The course used numerous examples of personal experience and examples from FDA audits of biotech and pharma companies which was critical in effectively understanding FDA regulations, audits and quality systems. I have been able to make a direct comparison between my company's current quality systems and what the FDA expects to see. This has not only provided me with a degree of reassurance, but has also enabled me to think of new ideas. I intend to implement change within my own manufacturing department which will assist in the monitoring and control of current process and systems. The course has been very thought provoking and a fantastic refresher."
Angela S., Reagents Manager, Genzyme Diagnostics
"Our instructor was very knowledgeable and very encouraging. Communication was excellent and she cared that we understood the course materials."
Sarah V., Regulatory Affairs Compliance Analyst, Paddock Labs
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