Friday, April 17, 2015

About the FDA's Office of Pharmaceutical Quality (OPQ) - FDA.gov

Read the full article: About the Center for Drug Evaluation and Research > Office of Pharmaceutical Quality - FDA.gov:

"What OPQ Does

OPQ is a new office within CDER that creates a single unit dedicated to product quality. The new structure, to be stood-up in January 2015, is expected to provide better alignment among all drug quality functions at CDER, including review, inspection, and research.

OPQ will combine non-enforcement-related drug quality work into one super-office, creating one quality voice and improving our oversight of quality throughout the lifecycle of a drug product. OPQ creates a uniform drug quality program across all sites of manufacture, whether domestic or foreign, and across all drug product areas – new drugs, generic drugs, and over-the-counter drugs."

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Read more about the OPQ:

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Wednesday, April 8, 2015

Calling all QA/QC whizzes: US FDA 'super' office hunts quality leader - in-Pharma Technologist

Read the full article: Calling all QA/QC whizzes: US FDA 'super' office hunts quality leader - in-Pharma Technologist:

"Last week Janet Woodcock – Director of the Center for Drug Evaluation and Research (CDER) – sent a memo announcing the agency had begun recruiting for the permanent Director of the new “super office,” calling for those looking to lead the CDER in matters related to the regulation of pharmaceutical quality to apply before April 14."

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Tuesday, April 7, 2015

Advanced GMP Training - The Qualstar Pharma Simulation

QUALSTAR - PHARMACEUTICAL SIMULATION (GMP TRAINING)

This cGMP training course excites, energizes, & engages students! --- Topics cover documentation, following procedures, change control, deviations, & more.

Do you have problems with documentation, following procedures, change control or deviations?

If you said, "Yes," then read on ...  Employees work in small teams in this unforgettable 3-4-hour industry simulation. The importance of documentation, procedures, change controls and deviations are stressed through competition, citations, fines, injunctions, and in some cases, even jail terms. A very short lecture component is customized to address your site’s specific compliance needs.

Learn more:  QUALSTAR - PHARMACEUTICAL SIMULATION (GMP TRAINING)

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