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The Center for Professional Advancement, Amsterdam, The Netherlands
16-17 June 2008
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:- Regulatory Affairs
- Quality Assurance/Control
- Plant Management
- Auditing
- Engineering
- Research & Development
- Quality Systems Management
- Documentation Management
The course will focus on various types of inspections in the pharmaceutical and related industries and will look at policies, procedures and experiences relevant to those inspections. Description
This course provides an overview of the FDA inspection process in general and of particulars applicable to “foreign inspections”. It provides a background and understanding of the role played by the Agency, its administrative and enforcement powers. The course provides a step by step description of the inspectional process with specific examples regarding cGMP compliance inspections and pre-approval inspections.
The latest FDA initiatives regarding inspections, like risk based approach and system based approach, will be discussed in detail. This will enable participants to better understand how to prepare their companies for FDA inspections.
The course consists of lectures, discussions, case studies analysis, and a hands-on workshop in setting up a company policy/procedure for handling inspections.
Attend this course and its companion course. Auditing for cGMP Compliance, ID#1881 (Offering # 0806-302) and save $400 off the combined tuition (Note: Only combined regular tuition applies)
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Organized by:
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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 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, the International Society for Pharmaceutical Engineering (ISPE) and is fluent in French.
Ms. Galkin is a frequent speaker at professional conferences and directs other 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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info@cfpa.com
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