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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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13th Annual FDA Inspections Summit

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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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FDA Clears Viseon’s Voyant System

The device allows the surgeon to change the depth of focus and view the surgical site on HD flat-panel display monitors.
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FDA Advisory Committee Nixes Trevena’s Opioid in Tight Vote

The FDA concluded there was insufficient evidence for a safety advantage compared to morphine.
FDAnews Drug Daily Bulletin

FDA NAMES NEW DIRECTOR OF OFFICE OF COMPLIANCE

June 23, 2006
KEYWORDS FDAnews Drug Daily Bulletin
A A

Deborah M. Autor will be the new director of CDER's Office of Compliance, the FDA announced recently.

Autor joined the Office of Compliance in 2001 as a senior adviser and has been the office's associate director for compliance policy since 2002. She led the reintegration of the Division of Scientific Investigations into the Office of Compliance and has been instrumental in spearheading the FDA's initiative to deal more aggressively with unapproved drugs, said the agency.

Prior to her work at CDER, Autor was a trial attorney in the Department of Justice's Office of Consumer Litigation, where she prosecuted civil and criminal cases under the Federal Food, Drug and Cosmetic Act.