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CfPA - The Center for Professional Advancement, Free Webinar
July 14, 2010 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend
This FREE webinar will be of value to those professionals in the pharmaceutical, medical device and related industries who are responsible for or involved in any interaction with vendors and suppliers, including those involved in:
• Management
• Auditing
• QA/QC
• R&D
• Manufacturing
• Regulatory Affairs
• Laboratories
• Purchasing
• Procurement
• Legal
• Validation
• Documentation management Description
This 60 minute Free webinar will present a brief overview of the outsourcing process in the FDA regulated industries with emphasis on the critical aspects of monitoring and preserving the integrity of the supply chain as well as the importance of risk management techniques. Details about steps to be taken by companies in setting up and implementing vendor and supplier audits will be discussed.
COURSE OUTLINE
The following will be addressed:
• Regulatory background
• Industry perspective
• Ways to classify vendors and suppliers
• Vendor/supplier selection map
• Initial audits - use of checklists
• Selection and approval process
• Legal Contract and Quality Agreement
• Monitoring the supply chain
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Organized by:
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CfPA - The Center for Professional Advancement |
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Invited Speakers:
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Renée B. Galkin, Quality Management Consultant
Renee B. Galkin is a quality management consultant with over twenty years experience in the pharmaceutical and medical device industries. Her areas of expertise include quality audits, quality systems, FDA regulatory compliance, GMP training, documentation systems management, strategic planning and organizational development.
Prior to starting her own consulting business, Ms. Galkin held managerial positions with two major companies - Wyeth Pharmaceuticals, Inc. (now Pfizer) and Science Management Corporation (a multinational consulting firm). Throughout her career she had both domestic and international assignments.
Ms. Galkin holds an MBA in Business Management from New York University, an MA in Education from Brown University and a Bachelor of Science in Biology from Northeastern University. She is a member of the American Society for Quality, the Parenteral Drug Association and the International Society for Pharmaceutical Engineering (ISPE). As a consultant, Ms. Galkin provides training, auditing and compliance advisory services to companies worldwide. Through her consulting assignments, Ms. Galkin helped dozens of pharmaceutical and device companies in getting ready for FDA inspections and successfully passing the inspections. She also directs several technical courses offered by The Center for Professional Advancement (CfPA).
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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sberg@cfpa.com
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