FDAnews Announces: Raw Materials Risk Management in GMP Facilities Webinar, Jan. 8, 2015

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Increasingly FDA warning letters to GMP facilities cite violations in raw materials management. International GMP expert Mukesh Kumar shows webinar attendees experience-tested techniques of raw materials risk management to keep manufacturing operations cost-effective and liability-proof.

Raw Materials Risk Management in GMP Facilities
**FDAnews Webinar**
Jan. 8, 2015 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/RawMaterialsGMP

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

Using risk-based strategies can save manufacturers 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 a company 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.

International GMP expert Mukesh Kumar shows webinar attendees experience-tested techniques of raw materials risk management to keep manufacturing operations cost-effective and liability-proof.

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

Here’s just a sampling of what attendees will 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 the manufacturer. But it’s the manufacturer who must answer to the Form 483 or warning letter. Cut raw materials risks now.

Meet the Presenter:
Mukesh Kumar Ph.D. leads the RA/QA departments at Amarex, a full service pharmaceutical product development company in Germantown, Md. (http://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.

Who Will Benefit:

  •     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

Conference Details:
Raw Materials Risk Management in GMP Facilities
**FDAnews Webinar**
Jan. 8, 2015 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/RawMaterialsGMP

Tuition:
$487 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register:
Online:     http://www.fdanews.com/RawMaterialsGMP
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
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