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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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October 07, 2016 |
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CfPA-The Center for Professional Advancement, New Brunswick, NJ
March 14-15, 2017
Who Should Attend?
This overview course is intended for individuals whose functions have direct or indirect involvement with FDA inspections. These functions include among others:
• Executive Management
• Regulatory Affairs
• Auditing
• Documentation Management
• Plant Management
• Quality Assurance
• Quality Control
• Research and Development
• Engineering
• Technical Services 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 twenty years experience in the pharmaceutical and medical device industries. Her areas of expertise include quality audits, quality programs, FDA regulatory compliance, GMP 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 and the International Society for Pharmaceutical Engineering (ISPE). 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.
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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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The course offers methodologies and techniques on:
• How a firm should prepare for an FDA inspection
• Ways to train employees in view of the inspection
• How to ensure that required documentation is in place
• How to interact with the investigator—DO’s and DON’T’s
• What companies should do when the inspection ends
• How to reply to 483’s and warning letters
• Legal implications of non-compliance
• Post inspection actions
The course consists of lectures, discussions and a practical workshop which will enable participants to work in small groups and design a company procedure for handling FDA inspections.