Various firms are subject to various relevant and applicable federal regulations including, but not limited to, Good Laboratory Practice (GLP), Current Good Manufacturing Practice (cGMP), and Good Clinical Practice (GCP).
It is important for the industry to accurately understand the requirements under Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP).
This seminar is intended to help industry get better familiar with the GLP, GCP and cGMP requirements from regulatory, practical and compliance perspectives.
The speaker will walk you through regulatory and compliance requirements governing GLP, cGMP and GCP.
- Applicable Laws and Regulations
- FDA Guidance and Standards
- Major Misconception
- Overview of each regulation – GCP, GLP, GMP
- How each regulation is the same
- How each regulation differs
- Regulations and Requirements for Good Laboratory Practice
- Regulations and Requirements for Good Clinical Practice
- Regulations for Current Good Manufacturing Practice
- Speaker’s PASS-IT Recommendations: Best Practices
- Compliance Officers
- Regulatory Affairs
- Clinical Affairs
- Quality Assurance
- Research & Development
- Lab Personnel
- Anyone who require a general understanding of the FDA’s 3 major regulations