Inside FDA Compliance

ISPE’s picture

By: ISPE

(ISPE: Tampla, FL) --  ISPE, a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals, has announced the release of GAMP Good Practice Guide: Calibration Management, Second Edition, which coincided with the start of the 2010 ISPE Annual Meeting in Orlando, Florida, on Nov. 7. The guide, which helps users set up a calibration management system, has been updated to reflect changing regulatory expectations from the U.S. Food and Drug Administration (FDA).

NSF International’s picture

By: NSF International

(NSF: Ann Arbor, MI) -- NSF International, a provider of global food safety certifications, has launched an online tool to help food companies assess their readiness for certification to standards benchmarked to the Global Food Safety Initiative (GFSI). NSF International offers a free, 21-question online assessment tool to help companies evaluate their facilities’ readiness for compliance.

NSF International’s picture

By: NSF International

(NSF: Ann Arbor, MI) -- NSF International, a provider of global food safety certifications, has launched an online tool to help food companies assess their readiness for certification to standards benchmarked to the Global Food Safety Initiative (GFSI). NSF International offers a free, 21-question online assessment tool to help companies evaluate their facilities’ readiness for compliance.

FDA’s picture

By: FDA

(FDA: Silver Spring, MD) -- A public-private organization will provide produce growers and packagers with fundamental, on-farm food safety knowledge, in advance of a proposed produce safety regulation, the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture’s Agricultural Marketing Service (USDA/AMS), and Cornell University announced recently.

ISPE’s picture

By: ISPE

(ISPE, Tampa, FL) -- ISPE, a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals, will offer seven training courses, including a session focused on complying with 21 CFR Part 11, at its 2010 ISPE Philadelphia Classroom Training. The event will take place Dec.6–9 at the Hilton Philadelphia Airport in Philadelphia.

UBM Canon’s picture

By: UBM Canon

(Canon Communications: Los Angeles) --  Find out why the BIOMEDevice Exposition and Forum is the trusted resource for medical product development, project acceleration, and learning what’s ahead for medical device technology on Nov. 10–11 at the San Jose McEnery Convention Center in San Jose, California.

Sparta Systems Inc.’s picture

By: Sparta Systems Inc.

(Sparta Systems: Holmdel, NJ) -- Despite making strides in improving quality across the supply chain, companies in the pharmaceutical, medical device, and food and beverage industries still face innumerable challenges in ensuring and maintaining supply quality. To address these challenges, Sparta Systems Inc., a provider of enterprise quality and compliance management solutions, recently outlined three key recommendations for companies seeking to improve supplier quality management while maintaining operational efficiency and profitability.

TÜV Rheinland of North America’s picture

By: TÜV Rheinland of North America

(TUV Rheinland of North America: Newtown, CT) -- TÜV Rheinland, a European notified body for numerous European Union (EU) directives, announced a new service guarantee for 10-day turnaround of CE marking certificates for the Medical Device Directive (MDD) of the European Union (EU). Setting a new standard for the industry, TÜV Rheinland offers North American medical device manufacturers an expedited process for receiving MDD CE marking certificates, resulting in a quicker path to certification and shorter time to the EU market.

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