The Controls for Outsourcing Manufacturing and Testing
Date & Time: Thursday, July 14, 2011
10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes
Instructor: Howard Cooper
Price : $245.00
(for one participant)
Overview: Howard Cooper President, EQACT, Inc.
The webinar will begin with a brief review about the importance of quality systems and their role in maintaining the organization. Outsourcing will be defined and examples throughout the FDA regulated industry will be discussed. Of course, regulatory requirements will be discussed to include the FDA's current thinking about the required controls. Particular emphasis will be given on the importance of understanding the differences between contractors and suppliers. This webinar will use many graphics to explain its important points.
Areas Covered in the Session:
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Defining and Analyzing the Outsourcing Environment. Regulatory Requirements For Outsourcing-Drugs & Devices Planning For Outsourcing The Resourcing Lifecycle The Quality Agreement-Defined Responsibilities Design and change control Maintaining control and problem solving Post-approval aspects of outsourcing Quality Improvement and Resourcing Covering the loopholes
Click here to register for this webinar Who Will Benefit: l l l l l
Regulatory Affairs Purchasing, Procurement, Outsourcing Depts R&D All of Quality Senior Management
Howard enjoys sharing his 30 years plus experience in starting up, developing, implementing, managing, and remediating pharmaceutical and medical device quality systems. He has a BS in Biology/Chemistry and Political Science as well as work toward an MBA. His ability to quickly learn the technology is demonstrated by his success in applying quality assurance principles to a wide range of pharmaceuticals and medical devices. He is a Certified Biomedical Auditor (CBA), Certified Quality Manager (CQM), and Quality Auditor (CQA). His technical education is further complemented by his Political Science degree helping him understand the regulatory process; his work toward an MBA provides business insight. He is a member of ASQ, PDA, AAMI, RAPS, and SQA. He strongly believes that Quality is very influential in shaping successful operations. He knows how to use his leadership abilities to build organizational relationships that make systems operate effectively as well as to develop and empower people. ...more
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The webinar will begin with a brief review about the importance of quality systems and their role in maintaining the organization. Outsourci...