Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products™

Course Description

This course is designed to provide participants with an understanding of the parameters for regulatory compliance, successful approaches to compliance, and meeting the concerns of regulators. Attendees will leave with a comprehensive set of tools for preparing regulatory initiatives, coping with challenges, and managing compliance.

Additional benefits of this class include:

• FDA authority and processes including 483s, Warning Letters, recalls, and other potential actions
• The FDA electronic submission procedures
• A chance to actively learn from fellow participants, as well as from an instructor who is a former FDA investigator and brings 20 years of practical compliance experience to a lively lecture and discussion

Who Should Attend

This course provides a comprehensive, cost effective compliance strategy for professionals in the drug industry. The course is designed to provide attendees with a strong foundation for understanding the regulatory requirements of the US FDA. The content is ideal for those looking for an introduction to regulatory compliance or who need a refresher on current compliance trends within the regulated environment.

Typical attendees include those in the following disciplines:

• Regulatory Affairs
• Manufacturing/Production
• Research and Development
• Quality Assurance & Control
• Development and preparation of submission material
• Laboratory operations

The course is ideal for new hires, as well as Managers, Directors, and Vice Presidents of Regulatory Affairs and Quality Assurance. All levels of experience will benefit from this course.

Learning Objectives

The course is designed to give participants a strong foundation in the fundamentals of FDA regulatory compliance for drug products. Additionally, this course will detail how to meet compliance objectives in a cost-contained manner. Upon completion of the course attendees will:

• Understand the guidelines, philosophy and practical approach to FDA compliance
• Explore the key strategies to cost-effective compliance: use of outsourced assistance, internal audits, the drug development and approval process, Quality by Design, reliance on electronic submissions, remediation plans and proper FDA communication
• Have resources for reference and update of latest regulations

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<