In-house Educational Training Programs

Good Manufacturing Practices

1. Global Regulations and Guidance's for GMP for Clinical Supply Activities and Operations (summary version)
This module covers the specific GMP requirements for IND drugs and the departures from 21 CFR Part 211 GMPs.  It does not cover the 211's, but only identifies those areas where traditional compliance approaches must be replaced with innovative and creative approaches. Illustrations of these novel approaches are provided.

2. Using Global Regulations and Guidance's to Define Best Practices for Good Manufacturing Practices for Clinical Supply Activities and Operations (detailed version)
The expanded version interprets each item in the FDA, EU, Canadian and Japanese clinical supply and investigational medicinal product regulations and guidance documents and provides examples of "good" manufacturing practice as well as "best" practices.

3. Similarities and Differences in US GMP and EU GMP for Investigational Materials
Many of the basic aspects of GMP (e.g., having a Quality unit, conducting activities with trained personnel) are common throughout the world. We will briefly cover the similarities and emphasize the differences in the regulations and their interpretation for investigational clinical trial materials.

4. Annex 13 - How to handle the Tough Issues here in the US
The EU Annex 13 to GMP describes over 50 alternatives to traditional approaches for clinical supply chain activities and operations.  This topic includes those that impact US-based companies doing clinical trials in Europe, including expiration dates on the label, the function of the information needed by the QP and importation into the EU.

5. CMC and GMP Issues Specific to Japan
Conducting clinical trials in Japan involve knowing the "nuances" of the unique requirements in this region.  We will cover both CMC development, CMC regulatory submission and GMP issues.