Course offering number:0808-305
Course ID:
2012
cGMP Auditing - Strategies for Compliance
August 11, 2008
New Brunswick, NJ
Renée B. Galkin; Quality Management Consultant
Renée B. Galkin is a quality management consultant whose
expertise includes FDA regulatory compliance, quality audits,
cGMP training, documentation systems management, SOP
standardization and organizational development. Prior to starting
her own consulting business, Ms. Galkin held managerial
positions with two major companies. She was part of
Corporate Quality Assurance at Ayerst Laboratories, a division
of American Home Products Corporation (now Wyeth), where
she managed quality audit programs in preclinical, clinical and
manufacturing areas. Previously, Ms. Galkin was associated
with Science Management Corporation, a multinational
consulting firm, where she had both domestic and overseas
assignments.
Ms. Galkin holds an MBA in Business Management from New
York University, a Master degree in Education from Brown
University and a Bachelor of Science degree 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).
Ms. Galkin is a frequent speaker at professional conferences
and directs other technical courses offered by The Center for
Professional Advancement.
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