The Controls for Outsourcing Manufacturing and Testing
Date & Time: Wednesday, December 7, 2011
10:00 AM PST | 01:00 PM EST
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.
Why should you attend: This course will help you understand your responsibilities when outsourcing so that the product maintains its integrity and quality and satisfies customer and user requirements. The FDA is closely scrutinizing these activities to assure that responsibilities outlined in the regulations and guidance is clearly defined between the contractor and its client.
Areas Covered in the Session: l l l l l l l l l l
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
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. ...more
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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
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel
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