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CfPA - The Center for Professional Advancement, Free Webinar
June 16, 2010 at 11:00 a.m.–12:00 p.m. (ET)
Who Should Attend
This FREE webinar will benefit those in the pharmaceutical, device and related industries, directly or indirectly involved in FDA inspections. Personnel in the following functions will find the presentation beneficial:
• Executive Management
• Quality Assurance and Control
• Auditing
• Documentation Management
• Regulatory
• Manufacturing
• Laboratories
• Research and Development
• Training
• Engineering
• Vendors/suppliers to industry
Description
This 60 minute FREE webinar presents a brief overview of the Agency role and authority and the types of inspections performed. It also outlines basic strategic steps to be taken by companies in order to get ready and successfully managing FDA inspections.
COURSE OUTLINE
• Agency role - administration and enforcement powers
• Pre-approval & routine inspections
• How firms prepare for inspections
• Successfully managing the inspection
• Understanding the inspection process
• Entrance conference
• Conduct of inspections
• Exit conference
• Enforcement tools
• Responding to 483's - follow-up
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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
Renee 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 systems, 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. Through her consulting assignments, Ms. Galkin helped dozens of pharmaceutical and device companies in getting ready for FDA inspections and successfully passing the inspections. She also directs several technical courses offered by The Center for Professional Advancement (CfPA).
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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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sberg@cfpa.com
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