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CfPA-The Center for Professional Advancement, Amsterdam, The Netherlands
9-10 June 2016
Who Should Attend?
This intensive, practical two-day course 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 suppliers, including those working in:
• Management
• Laboratories
• Auditing
• Purchasing
• QA/QC
• Procurement
• R&D
• Legal
• Manufacturing
• Validation
• Regulatory Affairs
• Documentation Management Course Description
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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 |
Renée 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 programs, FDA regulatory compliance, cGMP 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, the International Society for Pharmaceutical Engineering (ISPE) and is fluent in French. As a consultant, Ms. Galkin provides training, auditing and compliance advisory services to companies worldwide. She also directs several technical courses offered byThe 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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This practical course will outline details 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. The importance and use of risk management techniques will be presented.
The course will present the latest industry approaches and practices in setting up and implementing supplier audits and will discuss concrete steps to be taken by companies all over the world, when implementing this program. Case studies and group hands-on workshops will give participants an opportunity to brainstorm and create real life documents.