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Devise and Implement a Bullet-Proof Drug Validation Plan
The cumbersome paper-based validation of the 1980s is still alive and well in the drug world. Delays are rampant and budgets are ballooning — new capital projects show validation costs eating up as much as 15% of total investment.
The good news: there’s an alternative, and you can learn about it on from industry expert Herman Bozenhardt, who’s helped companies like yours take those costs all the way down to 2%.
ICH, GAMP, and ISPE have provided validation tools that the FDA endorses, but many have failed to adopt. This presenation explains how to use these standards to create risk-based assessments to increase compliance, minimize the spiraling costs of validation and reduce project delivery time.
In just 90 minutes Bozenhardt will educate you on the regulatory basis, the technical requirements, and the implementation method. Afterwards, you’ll have a clear direction on how to reduce your validation and finally rid yourself of the 1980s.
You will learn:
This course will benefit anyone invlolved in:
Herman Bozenhardt has 39 years of experience in pharmaceutical, biotechnology and medical device manufacturing, engineering and compliance. Mr. Bozenhardt’s expertise is in a wide spectrum of processes, engineering, compliance and computer systems and related technologies. Mr. Bozenhardt is also a recognized expert in the area of aseptic filling facilities and systems, with service to Novo Nordisk, DSM, Catalent, Organon Teknika, Bausch and Lomb, Alcon, J&J, Bristol Myers Squibb, and Janssen Pharmaceuticals, as well as operations positions within Pfizer. Mr. Bozenhardt has extensive experience in the manufacturing of therapeutic biologicals and vaccines via cell culture technology, human plasma derivation and egg-based technologies. Prior to being an executive consultant, Mr. Bozenhardt was an engineering executive with Life Sciences International, Foster Wheeler, Aker Kvaerner, and KBR. Mr. Bozenhardt has a BS in Chemical Engineering and MS in System Engineering from the Polytechnic Institute of Brooklyn (now Polytechnic Institute of NYU).
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