Self-Inspections are an integral aspect of the Good Distribution Practices (GDPs). Too many folks think that third party inspections are enough to ensure GDP compliance. While helpful, they cannot replace self-inspection protocols. Even though self-inspections are required for GDP compliance, many regulators find that they are either not carried out or are insufficient in their scope.
What you will learn:
- Explain the importance of self-inspection for GDPs
- List the four parts of a great self-inspection program
- Identify the value of a Root Cause Analysis (RCA) vs a CAPA
- Define the areas to focus on for a good self-inspection program
About the Speaker
Global BioPharm Solutions
Steve is a successful trainer, business leader, consultant, executive coach and speaker. For the past 25 years he’s been heavily involved in clinical supply chain operations, IMPs, cGMPs, cGCPs, cGDPs, clinical development and quality (ICH Q8, Q9 & Q10) for pharmaceuticals, and biotech products.
He sits on the Board of Directors of the largest professional clinical supply organization in the world, the Global Clinical Supplies Group. His expertise also includes success in innovation, global cultural dynamics, organizational development, and high performing teams.
In the past he has been a CEO and COO, as well as the president and Global Chief Operating Officer, of a multinational clinical supply chain contract organization that served companies like Novartis, Eisai, Lilly and others in the pharmaceutical and biotech sector. Before that he was head of US clinical supply operations for Johnson & Johnson.
Steve was also a logistics and aviation officer, in the U.S. Army, where he rose to the rank of Major and was a maintenance test pilot, and pilot in command, for both helicopters and fixed wing aircraft.
His undergraduate degree is in Pharmacy from the University of the Sciences in Philadelphia and his MBA is from the University of Phoenix with a specialization in global management.