Who Should Attend
This course provides a comprehensive, cost effective compliance strategy for professionals in the drug and biologics industries. The course is designed to provide attendees with a strong foundation for understanding the regulatory requirements of the US FDA. 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 drugs and biotech 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 seven key strategies to cost-effective compliance: use of outsourced assistance, audits, simultaneous submissions, Quality by Design, use of operational definitions, reliance on electronic submissions, and prioritization of guidelines
- Have resources for reference and update
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 brief comparison with other national regulatory compliance issues
- A chance to actively learn form fellow participants, as well as from an instructor who brings 30 years of practical regulatory experience to a lively combination of lecture, discussion, and exercises.