Complimentary In-Person cGMP Course for Regenerative Medicine Technologies
Register Now!
Don’t miss this valuable opportunity to enhance your knowledge of FDA regulations governing the regenerative medicine technology industry!
- When: Friday, June 6
- Time: 8:30 AM – 12:30 PM
- Location: Robert S. Strickland Center, Room RLS 2495
Forsyth Technical Community College, Winston-Salem, NC - Instructor: Tim Hamm, Industry Expert from NC BioNetwork
- Cost: Complimentary (No cost to attend!)
Course Overview
Join us for a hands-on, expert-led class designed to introduce and explore the principles of Current Good Manufacturing Practices (cGMP) as they relate Regenerative Medicine (RM) technologies.
Led by Tim Hamm, a respected industry leader from NC BioNetwork, this in-person session provides practical knowledge and regulatory insights vital for professionals, future workforce trainees, and anyone entering or working in biotech sectors.
What You’ll Learn
- Types of RM technologies
- The FDA’s role in regulating and overseeing devices
- History of U.S. device regulation
- Device classification and clearance processes
- Enforcement and inspection procedures
- Comparison of 21 CFR 820 (QSR) and ISO 13485 standards
- Good Documentation Practices
- How to navigate the FDA website and utilize FDA resources
Learning Objectives
By the end of this course, you will be able to:
- Explain what qualifies as a RM technology
- Describe how the FDA regulates RM technologies
- Identify key aspects of FDA oversight and enforcement
- Understand Quality System Regulations (QSR)
- Compare ISO 13485 to QSR and explain ISO certification processes
- Apply Good Documentation Practices (GDP)
- Confidently search FDA tools and databases
Reserve Your Spot
This complimentary class has limited seating — register now to secure your place!