Inside FDA Compliance

ISPE’s picture

By: ISPE

(ISPE: Tampa, FL) -- As part of its 2011 conference, “Applying Solutions to Emerging Industry Challenges,” the International Society for Pharmaceutical Engineering (ISPE), a global, nonprofit association of more than 22,000 professionals, will feature eight educational sessions designed to help pharmaceutical companies identify and address compliance risks prior to FDA inspection. The conference will take place Feb. 21–24 at the Grand Hyatt Tampa Bay in Tampa, Florida.

URAC’s picture

By: URAC

(URAC: Washington) -- URAC, a leading health care accreditation and education organization, has released revisions to three products within its suite of Pharmacy Quality Management Accreditation programs. These revisions are part of organization’s commitment to regular comprehensive review of its standards.

Vinca LLC’s picture

By: Vinca LLC

(Vinca LLC: Eden Prairie, MN) -- Quality systems professionals at Vinca LLC have outlined the steps to use in developing quality management systems with clients. The first step they recommend is to complete a thorough project plan.

EAGLE Registrations Inc’s default image

By: EAGLE Registrations Inc

(EAGLE Food Registrations: Dayton, OH) -- EAGLE Food Registrations Inc., specializing in third-party certification to international management system standards, announced it will begin certifying companies to the Safe Quality Food (SQF) Ethical Sourcing Standard on Jan. 3.

Underwriters Laboratories UL’s picture

By: Underwriters Laboratories UL

(UL: Northbrook, IL) --  Underwriters Laboratories (UL), a world provider of product safety testing and certification, has released an extensive resource, “UL’s Comprehensive 60601 3rd edition Q&A” that addresses more than 70 frequently asked questions (FAQ) regarding IEC 60601 third edition, which includes the latest revisions to the internationally harmonized safety standard for electro-medical equipment.

Taran March’s picture

By: Taran March

Despite recent headlines targeting Johnson & Johnson’s uncorrected manufacturing problems and deficiencies, most makers of approved drug and biological products are meeting their regulatory obligations and targets for postmarketing studies and clinical trials in a timely manner, according to a study released by the U.S. Food and Drug Administration (FDA).

Cognex Corp.’s picture

By: Cognex Corp.

(Cognex Corp.: Natick, MA) -- Tough competition means food and beverage manufacturers and packagers cannot afford production errors. This is why they must increasingly rely on machine vision systems and image-based ID readers to help achieve quality, improve productivity, and comply with product safety regulations—all while reducing manufacturing costs.

By: Agilent Technologies

(Agilent Technologies: Santa Clara, CA) -- Agilent Technologies Inc. has introduced the 708-DS Dissolution Apparatus, a quality control instrument that can be configured for manual and automated applications. The new device includes an improved design that minimizes variability and improves results. Dissolution is a technique used in the pharmaceutical industry to determine the rate at which pure active pharmaceutical ingredients dissolve.

Pilgrim Software’s picture

By: Pilgrim Software

(Pilgrim Software Inc.: Tampa, FL) --  Pilgrim Software Inc., a  global provider of enterprise risk, compliance, and quality management (ERCQM) software solutions, has announced the availability of SmartSolve 9, the latest and most enhanced version of its integrated process automation platform.

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).

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