Cleaning Validation Risks Front-Line Strategies for an Effective and Compliant Program

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Your manufacturing equipment may be clean, but is it FDA-clean?

Thousands of drug doses or devices may be at risk if your equipment isn’t properly validated for cleanliness. This webinar shows you how to get it right.

Concept Laboratories didn’t expect the warning letter. Like so many drug and device facilities, equipment cleaning was second nature — something employees do every day.

Even so, the company was cited by the FDA for everything from missing documentation of cleaning validation studies already completed to an incomplete Cleaning Validation Master Protocol.

Make no mistake: the FDA is watching both your methods and your record keeping.

And if your equipment isn’t properly validated, you could face more than a warning letter or fine. Entire runs can be lost to cross-contamination and may halt production altogether.

Why let the threat of shutdown loom? Register today for Cleaning Validation Risks, the 90-minute webinar that gives you the confidence to:

  • Take three critical steps before any cleaning validation on equipment process begins
  • Tell when your equipment is FDA-clean with proven sampling and analytical methods
  • Create a complete Cleaning Validation Master Protocol — why it matters, five key components you must include
  • Establish SOPs and build your documentation — the vital proof your company needs for cleaning agents and testing equipment
  • And much, much more

With more than two decades of experience, your webinar expert Rich Yeaton has worked with everyone from Merck to Genzyme to DuPont. And in Cleaning Validation Risks, he reveals the front-line cleaning validation techniques you need to stay FDA‑compliant.

When a Simple Cleaning Solvent Can Trigger Disaster,
These Real-World Case Studies Help You Sidestep Common Pitfalls

Even if you’re already up to speed on the fundamentals of cleaning validation, Cleaning Validation Risks will show you — using industry case studies — why the basics are no longer enough to please the FDA. Sign up your entire team to discover:

  • Which filters, gaskets and other common components hold hidden dangers — and the right way to validate their cleanliness
  • Why overlooked “multi-product contact points” along your processing path can create cross-contamination threats
  • How to avoid losing a product run to the wrong solvent — even trace amounts can fail to remove particles of prior drugs or leave behind residues of their own
  • Plus many more must-have details

Time after time, from biotech to drugs and devices, your colleagues report in that the Cleaning Validation Risks webinar is an opportunity you can’t afford to miss:

“Great content and well presented.” — Mitch Dean, Manager of Validations at Sandvik Medical Solutions

“...very good job in explaining the details of cleaning validation.” — Gautam Shah, Senior Manager at Caraco Pharmaceutical Labs, Ltd.

“All aspects from cleaning samples, analytical methods and documentation are explained.” — Jean Normandin, Validation Manager at Covidien

Don’t let it pass you by! Click here to sign up now for the popular 90-minute FDAnews webinar, Cleaning Validation Risks. Everyone in your organization with a role in cleaning validation deserves to take part in this event — and they can do so, at a cost that won’t break the budget. You pay a single low registration fee per facility, regardless of how many participate. So spread the word.

This is a workshop you attend without leaving your workplace. Simply make sure you’re in front of a screen at the appointed time. Have questions? Submit them via email for answers by the time the session ends.

  • Auditors
  • Compliance officers
  • Consultants/service providers
  • Engineering and design control teams
  • Executive management
  • General/corporate counsel
  • Investigators
  • Managers
  • Manufacturing directors and supervisors
  • Personnel new to the industry
  • Pharmaceutical and cGMP auditors
  • QA/QC personnel
  • R&D staff
  • Regulatory affairs professionals
  • Risk management specialists
  • Training personnel
  • Validation specialists, scientists, engineers

Rich Yeaton, president of East Coast Validation Services, LLC, has more than twenty years of experience working in FDA regulated industries. He was initially introduced to GMP operations on the devices side as a development engineer in DuPont’s Medical Products Division. There he developed and improved new process equipment and was told to validate what he had designed.

He moved on to help start Phoenix Imperative, an engineering and validation consulting company serving the biopharmaceutical industry. A key achievement with Phoenix was leading validation teams at two MedImmune cell culture facilities to assist 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. Rich recently assisted Avecia Biologics, a microbial fermentation contract manufacturer, to successfully prepare for itsfirst preapproval inspection held in January 2009. His is a member of the ASME, the ISPE and the PDA, and has degrees in electrical engineering and mechanical engineering from Lehigh University.

Register now!

Date: Feb. 15 – March 5, 2010
Location: Your office or conference room (no need to travel!)
Time: Anytime

Invite your entire team for maximum benefit!
Register TODAY for one dial-in and log-in —
and bring as many participants as you wish.

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Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
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Or, register by phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Registrations may not be cancelled. Please contact customer service to make any substitutions.

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