Mr. Martin Browning This is Me

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1. 1. www.fdanews.com

   www.fdanews.com/newsletter/art - [Cached]

   Published on: 5/16/2008   Last Visited: 5/16/2008

   Martin Browning, president of EduQuest, an FDA-compliance consulting firm, said when companies outsource, the QA department should expand so it can monitor outsourcing activities.
   
   Hiring more QA staff is "not an unusual thing, but it typically, unfortunately, occurs as a result of a correction or a corrective action - after a problem has occurred," Browning said during an FDAnews audioconference.
   
   "All too often … we outsource some process, and we think, 'Well now we don't need those three or four quality assurance people to handle that for us because our outsource partner is doing that,'" he said.
   
   He cited a recent case in which a devicemaker was fined $2.2 million for GMP violations involving outsourcing.
   
   Browning said firms can expect the FDA to look harder at how outsource companies are evaluated, how they're selected and how auditing and monitoring processes are carried out by the manufacturer.

2. 2. www.fdanews.com

   www.fdanews.com/conference/det - [Cached]

   Published on: 4/15/2008   Last Visited: 4/15/2008

   Martin Browning is your course leader. A former FDA top official, Martin helped draft the original Part 11 regulations. He and his team have trained hundreds of key FDA and industry personnel. Now that same training is available to you and your staff.
   
   Martin, president and cofounder of EduQuest, 2004 IVT Speaker of the Year, capped a 22-year FDA career as a special assistant to the associate commissioner for regulatory affairs. As vice chair of the electronic record and signature working group, he helped draft the original 21 CFR Part 11 regulations. He also served as the chair of the U.S. government's ISO 9000 committee, and was a member of the committee that developed the medical device quality system regulation.

3. 3. www.fdanews.com

   www.fdanews.com/conference/det - [Cached]

   Published on: 4/29/2008   Last Visited: 4/30/2008

   Former top FDA investigator Martin Browning explains how the FDA expects you to manage and monitor outsourced activities in your supply chain.
   ...
   Martin Browning is the founder and president of EduQuest. He spent 22 years with the FDA as a local, national and international expert investigator, then served as special assistant to the Associate Commissioner for Regulatory Affairs. He also served as the vice chair of the agency's Electronic Records and Signatures Working Group, which drafted the 21 CFR Part 11 regulations. Martin, former chairman of the U.S. government's ISO 9000 committee, served on the Global Harmonization Task Force and on the committee that developed the good manufacturing practice regulations for medical devices, otherwise known as the Quality System Regulation. He is the program chairman of the week-long Compliance Boot Camp presented by EduQuest in cooperation with FDAnews.
   
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