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Gmp-inspection-preparation-checklist-130x160

GMP Inspection Preparation Checklist: A Tool for Internal Auditing

This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
Biological-risk-eval-and-mngmnt-for-md-130x160

Biological Risk Evaluation and Management for Medical Devices

Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

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Oct 17

Quality Metrics Redux: Taking Advantage of FDA’s Renewed Focus

Oct 18

Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2)

Oct 18

The CDER Reorganization: What It Means for Drugmakers

Oct 23

13th Annual FDA Inspections Summit

Oct 30

FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers

Oct 30

Understanding ISO 19011:2018: The Path to Better Medical Device System Audits

Editor's Picks

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Green_light

Health Canada Gives Green Light to Medtronic’s Insulin Pump

The company expects to launch the insulin pump in Canada this fall.
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Lawsuit Accuses Westminster, CVS of Selling Recalled Thyroid Tablets

The complaint alleges that Westminster knew there were problems with the drugs for months but didn’t recall them until after the FDA forced its hand.
FDAnews Drug Daily Bulletin

PIC/S, EMA Agree to Harmonize Drug GMPs to Bolster Data Trades

Aug. 17, 2012
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The international Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the European Medicines Agency (EMA) are harmonizing their good manufacturing process (GMP) guides for drugs to ease the flow of shared inspection data. The two entities agreed to merge their respective GMP guides and related documents in a recent addendum to their two-year cooperation compact. That accord expires at the end of this year and the pair said they may renew the agreement after assessing their efforts.
Drug GMP Report