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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.
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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.

Events

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Nov 27

Returning Plain-Language Summaries to Research Participants: Best Practices for Sponsors and the…

Nov 28

REMS: Requirements, Regulation, and Enforcement — Evolution from Safety Program to Enforcement Tool

Nov 29

Chinese Medicine: The Dangers of Deployment — The Impact on Pharmaceutical Regulatory and…

Dec 4

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

Dec 5

Laboratory Developed Tests, In Vitro Diagnostics & Gene Therapies: DAIA Will be a Game-Changer

Dec 6

SOPs and Policies for the 21st Century: Why Less is More

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FDA Grants PMA for QView Medical’s Automated Breast Ultrasound System

The device is meant for breast screening in asymptomatic dense breasted women whose mammograms returned negative.
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Sandoz Announces Voluntary Recall of Potentially Contaminated Losartan

The affected product was distributed after October 8, according to the FDA.

SHIONOGI RELEASES CARBAPENEM ANTIBIOTIC KIT

KEYWORDS Daily International Pharma Alert
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Shionogi has launched Finibax 0.25g IV Solution Kit, a kit for its proprietary antibiotic agent Finibax (doripenem hydrate). The new kit, which offers an antibiotic agent and solution together, simplifies the dissolution procedure, preventing medical errors.

JCN Network (http://www.japancorp.net/Article.Asp?Art_ID=12687)