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Conducting Effective Quality Audits
October 29-31, 2019
New Brunswick, NJ
Course Offering 191029NJ1681
Course ID 1681
Who Should Attend?
This overview course is designed for those who have
recently been involved, or expect to be involved in internal
or external audits.
The program will benefit individuals in the pharmaceutical
and related industries, such as medical device, diagnostics,
cosmetics, food, biotechnology as well as vendors, suppliers
and contract organizations.
The course can be of interest to top management responsible
for audit programs in their companies as well as to
professionals in a variety of functions such as:
• QA & QC
• R & D
• Documentation Management
• Clinical Research
Renée B. Galkin; Quality Management Consultant
Renée B. Galkin is a quality management consultant with over 30 years experience in the pharmaceutical and device industries.
Prior to starting her consulting business, Ms. Galkin was part of two major companies: Science Management Corporation – a multinational consulting firm and then Wyeth/Pfizer where she gained her pharmaceutical experience during her 20 year association. Throughout her career Ms. Galkin held both domestic and international assignments.
Ms. Galkin has an MBA in Business Management from New York University, an MA in Education and Science 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). She is also a Certified Quality Auditor.
As a consultant, Ms. Galkin has been providing training and consulting advice to pharmaceutical and medical device companies in the United States and Europe in areas related to consent decrees, pre-approval and regular FDA inspections, audit programs, quality systems requirements, documentation systems management, validation, supplier selection and management.
She also directs several technical courses offered by the Center for Professional Advancement. Participants at her courses enjoy and appreciate her interactive and personal teaching style which keeps the audience alert and constantly involved.
New Brunswick, NJ Area
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