FDAnews Announces — Devise and Implement a Bullet-Proof Drug Validation Plan Webinar, Aug. 25, 2015

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ICH, GAMP, and ISPE have provided validation tools that the FDA endorses, but many have failed to adopt. This webinar 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.

Devise and Implement a Bullet-Proof Drug Validation Plan
**FDAnews Webinar**
Aug. 25, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/drugvalidationplan

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 drugmaker can learn about it on Aug. 25 from industry expert Herman Bozenhardt, who’s helped companies 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 webinar 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 attendees on the regulatory basis, the technical requirements, and the implementation method. After this webinar, attendees have a clear direction on how to reduce validation and finally rid themselves of the 1980s.

Attendees 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

Meet the Presenter:
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.

Who Will Benefit:
This course will benefit anyone involved 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

Conference Details:
Devise and Implement a Bullet-Proof Drug Validation Plan
**FDAnews Webinar**
Aug. 25, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/drugvalidationplan

Tuition:
$287 per site
Easy Ways to Register:
Online: http://www.fdanews.com/drugvalidationplan
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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