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Cleaning Validation: Best Practices for Maintaining a Compliant Global Program


Special $50 Off Savings! See the Registration section below.

Contaminated drugs, recalls, drug shortage, increased internal costs, financial loss, pollution and an increase in inspections. These are consequences you may face if your current cleaning procedures are not up to par.

Do your SOPs include a checklist for cleaning procedures? Do you use multi-purpose equipment? Are you prepared for an FDA inspector to walk through your doors tomorrow?

In 90 minutes, Rich Yeaton, President of East Coast Validation Services, LLC, an expert with more than 20 years of experience, will provide you with an understanding of the importance and underlying principles of cleaning validation and the requirements to have adequate cleaning procedures for manufacturing equipment.

During this webinar, you will discover:

  • Cleaning program differences across industries - pharmaceuticals, biologics, devices and raw materials
  • Changes to cleaning regimes required based on the 2009 FDA draft Process Validation Guidance
  • How to create a cleaning validation master plan, updating your current cleaning validation program, writing and organizing policies, procedures and work instructions
  • Defining the validation plan and test criteria pre-validation studies, Validation Runs and Setting Realistic Acceptance Criteria and Process Tolerances
  • Process control and improvement - routine process control, troubleshooting and failure investigations; and adapting programs to new products

For one low price, you and your entire team can take part in this fast-paced, insightful webinar. Best of all, you’ll be able to connect personally with our speaker, Mr. Yeaton, when we open up the phone lines for live Q&A.


 

FEATURED SPEAKER

Richard Yeaton

Rich Yeaton

President

East Coast Validation Services, LLC

Rich Yeaton is President of East Coast Validation Services, LLC. in Derry, NH, and has over twenty years experience working in FDA regulated industries. He was initially introduced to GMP operations as a Development Engineer in DuPont’s Medical Products division, where he developed and improved new process equipment, and then got to validate it. He then helped start Phoenix Imperative, an Engineering and Validation consulting company serving the BioPharma industry. A key achievement with Phoenix Imperative was leading validation teams at two MedImmune cell culture facilities, which enabled MedImmune to obtain their first two commercial licenses. He has since worked with small startup companies and larger operating companies such as Merck, Genzyme, Wyeth and Lonza. He has in-depth experience with facility shutdowns and startups. He recently assisted Avecia Biologics in preparing for their first Pre Approval Inspection, which was successful, as they received their commercial license in January 2009. He is a member of the ASME, the ISPE and the PDA, and has degrees in Electrical Engineering and Mechanical Engineering from Lehigh University.

REGISTRATION

Audio CD & Transcript

Audio CD & Transcript

$349  $299

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24/7 ENCORE Audio Presentation

24/7 ENCORE Audio Presentation

$349  $299

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Cancellations: Webinar registrations may not be cancelled. Registrants may substitute the 24/7 ENCORE Audio Presentation for the Live Webinar at any time. Please contact Customer Care to make substitutions.