Raw Materials Risk Management in GMP Facilities - Webinar CD/Transcript

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Your loading docks around the world are full of in-bound raw materials.  How to you determine what to open, inspect and/or test?  And what can head straight to the manufacturing floor?

Using risk-based strategies can save your company millions annually — while still being assured of GMP quality materials.

In 90 minutes learn how new, proven raw-materials risk management strategies can cut costs, save time and keep you off the FDA’s inspectional radar.

Increasingly FDA warning letters to GMP facilities cite violations in raw materials management. The FDA’s investigators give special scrutiny to sourcing, handling, control, use and tracking of raw materials.

It’s true across the broad spectrum of FDA-regulated manufacturers — drugs, biologics, medical devices, diagnostic kits, dietary supplements and veterinary products.

Let international GMP expert Mukesh Kumar show you experience-tested techniques of raw materials risk management to keep your manufacturing operations cost-effective and liability-proof.

Dr. Kumar will clarify current requirements for raw material management and give you the tips you need for practical implementation.

Here’s just a sampling of what you’ll discover:

  • What FDA expects from GMP facilities regarding raw material vendor selection
  • Proven, risk-based strategies to certify acceptable materials quality
  • Sampling and assurance — QC documentation goals and standards
  • Training requirements for front-line managers and staff
  • And much more!

Raw-material suppliers are notorious for making abrupt formulation changes without notifying you. But it’s you who must answer to the Form 483 or warning letter. Cut raw materials risks now. It’ll take only an hour and a half from your busy day.

  • Compliance/regulatory affairs
  • Managers of GMP facilities
  • Supply-chain managers
  • QC and analytical-methods scientists and managers
  • QA directors, managers and personnel
  • Purchasing and materials-control managers
  • GMP site personnel
  • Senior managers of companies using CMOs

Mukesh Kumar Ph.D. leads the RA/QA departments at Amarex, a full service pharmaceutical product development company in Germantown, Md. (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has had a hand in some 100 clinical trials 40+ countries, made several hundred FDA submissions, and arranged numerous meetings with the FDA. He also has had made regulatory submissions in both the EU and India. Previously he was a research scientist at the NIH, Baylor College of Medicine and premier institutions in India.