Devise and Implement a Bullet-Proof Drug Validation Plan - Webinar CD/Transcript

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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:

  • How ASTM E2500 and ICH Q9 were developed and why they’re superior
  • The benefits of leaving yesterday’s validation methods behind
  • Why “qualification” is a more accurate term than validation
  • How to save qualification costs
  • How to devise and implement a bullet-proof validation plan
  • How to rebuild a project model around new methodology
  • Rapid and cost-effective deployment of modern standards
  • How to execute a risk assessment
  • How to use this assessment for engineering, maintenance, and change control decisions
  • How to consolidate documents and executions, and leverage data
  • Adapted engineering and qualification workflow
  • Seamless compliance across multiple standards

This course will benefit anyone invlolved in:

  • Production
  • Engineering
  • Validation
  • Quality Operations
  • Anyone who needs to communicate internally with engineering, validation or quality personnel responsible for compliance, qualification and project implementation

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).