Course offering number:1206-202
Course ID:
1880
Surviving an FDA Inspection -- FDA Inspections of Non-U.S. Sites
5-6 June 2012
Amsterdam, The Netherlands
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 by The
Center for Professional Advancement (CfPA).
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