Analytical Method Validation Crash Course FDA Cracking Down on Method Validation and Reporting Deviations
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Don’t be among them. Sign up now for this intensive “total immersion” webinar.
Every FDA-regulated drug, biologic, contract manufacturer and contract lab must meet the same stark standard: All tests must be conducted under strict guidelines, and the FDA must be able to reproduce them and get exactly the same results.
Compliance continues to be a major struggle, judging by the uptick in form 483s and warning letters — with Savient, Forest, Provident and Bayer among those hit.
And it doesn’t stop with the FDA. Companies must also follow strict EMA and ICH requirements.
With the costs today of noncompliance delays amounting to millions of dollars in lost revenues, why not make a small investment in specialized training by a recognized expert? It’ll be one of the best investments you’ve ever made.
The Analytical Method Validation Crash Course takes place Tuesday, July 20, at 1:30 p.m. EDT. It’s an intensive “total immersion” webinar, designed for everyone in your organization with quality and validation responsibilities, featuring a well-known session leader who can impart the basics in a quick-paced 90 minutes.
Your instructor is consultant Melissa J. Smith, a veteran with more than 25 years of experience in the quality wars at Biogen, Stryker and other cutting-edge companies. She’ll dig deep into hot topics, including:
- Regulatory requirements you must comply with
- Complex processes for documentation and investigation of deviations
- Minimum requirements for determining precision, intermediate precision and robustness
- Distinguishing between requirements for qualification vs. validation
- How to know when a qualification is applicable and when a validation is required
- Regulatory expectations for analytical method validation protocols
- What it means to be scientifically sound, qualified, validated and verified
- Specific guidance requirements through the FDA, EMA and ICH
- And more!
Best of all, you don’t even have to leave your desk to participate. Or, you may wish to sign up dozens of colleagues and coworkers. If so, no problem — there’s no limit on the number who may participate at the same location. One low registration fee covers them all.
Expect a totally interactive experience. You’ll email your questions during the presentation and receive prompt, comprehensive answers by the end of the session.
Don’t risk multimillion-dollar delays bringing your products to market. Make sure your analytical procedures are squeaky-clean and your entire staff is up to speed. Sign up now.