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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.
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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.

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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

Nov 1

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

Nov 1

Brexit and the Impact to Your Global Business Operations: What Life Sciences Companies Need…

Nov 7

FDA’s New Biosimilars Plan: CBER’s New Policy and the Impact on Pharmaceutical Stakeholders

Editor's Picks

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Matrix Surgical’s OmniPore Implants Cleared for Marketing

The company expects to launch additional variants in early 2019.
Patentlaw

AbbVie, Novartis Reach Deal on Humira Biosimilar

AbbVie reported Humira sales of $18.4 billion in 2017.
FDAnews Device Daily Bulletin

DELPHI MEDICAL SYSTEMS EXPANDS IN THE RESPIRATORY CARE MARKET WITH WEARAIR LICENSING AGREEMENT

Dec. 13, 2005
KEYWORDS FDAnews Device Daily Bulletin
A A

Delphi Medical Systems, a subsidiary of Delphi Corp., recently signed an exclusive worldwide licensing agreement with Canada-based medical device company WearAir Oxygen, Inc. WearAir is a small company with a mission to improve respiratory patients' quality of life through an innovative proprietary oxygen concentration technology.

Yahoo News (http://biz.yahoo.com/prnews/051212/dem008.html?.v=28)