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CfPA-The Center for Professional Advancement, Online Live
August 21, 2018 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend?
This overview, introductory course will benefit professionals in a variety of functions in the pharmaceutical, medical device, biotech and related industries who are responsible for the writing, implementation or management of various types of documents. These functions include:
• Documentation writers/managers
• Regulatory
• Audit
• QA/QC
• Training
• Middle /Upper management
• Manufacturing
• Laboratory operations
• Pre-clinical operations 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 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.
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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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jmorbit@cfpa.com
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For in-depth training on this topic, consider the CfPA 2-day, in-person training:
Documentation Management and Control
Course ID #1866