"I have been through many trainings and seminars. This has been my best experience!" - Summer 2008 cGMP Class Participant

After receiving great feedback from the first two years of this course, MassBioEd is offering the cGMP training program again in 2010.

View a sneak peak of this course here:

GMP Training is a regulatory requirement by the FDA, and thus companies are required to provide this training to their employees. Several FDA rule changes went into effect in December 2008. Stay up-to-date and learn about these rule changes in this next program!

The goal of this course is to provide an introduction into the current Good Manufacturing Practices (cGMP) and to help companies and their employees remain in compliance with FDA requirements. The session will benefit individuals new to this highly regulated industry and will also serve as a refresher course for the experienced biotech employees.

Learning Objectives:

• Understand the importance of cGMPs and how history shaped cGMPs and FDA's role in regulating food and drugs.
• Review key terms common to the biopharmaceutical industry (ex. IND, ANDA, PAI, 483, Warning Letter, BLA, NDA, Aseptic Processing, Verification, Review, etc)
• Understand the key concepts of each subpart of 21 CFR Part 211, as well as EUGMPs, and 21 CFR Part 600, and how they apply to participants' specific jobs.
• Understand current thinking in cGMPs, including process control and continuous improvement, in the context of Quality Systems and recent guidances ICH Q8, Q9, and Q10, and FDA's Quality Systems Approach to Pharmaceutical cGMPs (2006)
• Understand consequences of not following cGMPs
• Create good GMP work habits, and apply Good Manufacturing and Good Documentation Practices on the job every day.

For more information or to register, visit the course webpage:
https://secure.massbioed.org/courses/index.php?page_function=detail&course_id=30