Description
FDA HCT/P audits are common and becoming more problematic. Don’t be caught unprepared. Make sure all your employees are aware of these regulations and realize how it impacts their work. We work in a regulated environment. These regulations exist to keep our HCT/Ps safe and free from microbial contamination and infectious diseases. The regulation, 21CFR Part 1271, is the keystone to keeping our donated cells and tissues safe. In this course, we will describe the regulatory law, the history behind it and, more importantly, the scientific rationale of these regulations. We will discuss the regulations and provide tips on how to implement these regulations in a practical format. This will be done in an interesting fashion with many real examples and case studies. This course will help create a culture of compliance at your facility. It is recommended that all your personnel receive regulator training annually and this 3 x 1-hour session course will fulfill this requirement.
Session 1: Introduction to the World of Drug Regulations and How 1271 and GTPs Fit into the Picture
- Instructor: Dr. Laureen Little
- Format: On-demand recording available now.
- Content: Review of the PHS and FD&C acts and their regulatory paradigms. Descriptions of the regulations and available guidances. Section 351 and 361 products and determination of minimally manipulation. Discussion about the 4 difference paradigms for manufacturing therapeutic products (drugs, biologics, devices and tissue/transplantation). History and discussion about how and why the regulations were implemented. The impact of health issues identified for transplant recipients. Description of 21 CFR 1271 regulations.
Click HERE to watch an excerpt from Session 1!
GTP vs. GMP for HCT/P
- Instructor: Dr. Laureen Little
- Format: On-demand recording available now.
- Content: GTP and GMP regulations as they apply to 351 and 361 products will be reviewed in-depth. Case studies and FDA audit observations will be discussed.
Click HERE to watch a trailer from Session 2!
Good Tissue (cGTP) Requirements – What They Are, How to Comply and Hot Topics
- Instructor: Dr. Laureen Little
- Format: On-demand recording available now.
- Content: Part 1271, Subparts D thru F. Deep dive into cGTPs, as outlined in Subpart D, including facilities, environmental controls, equipment, supplies and reagents, recover, processing and process controls, labeling controls, storage, receipt. Predistribution shipment and distribution. Recent HCT/P Inspection results.