Course offering number:0909-703
Course ID:
2309
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Introduction to cGMP System-Based Audits
In Conjunction with Wiley-Blackwell
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Renee 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 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, auditin and compliance advisory services to companies worldwide.She also directs several technical courses offered by The Center for Professional Advancement (CfPA).
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