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The Center for Professional Advancement, Amsterdam, The Netherlands
18-19 June 2008
Who Should Attend
Newly assigned auditors or those who expect to be involved in auditing in the near future, will find the course beneficial. Those individuals who expect their departments, groups or functions to be audited, will also find the program of great interest. Thus the course can be of interest to professionals in a variety of functions such as:- Quality Assurance
- Laboratory
- Quality Control
- Production
- Regulatory Compliance
- Engineering
- Packaging
- Purchasing
- R&D
- Vendors
Description
This practical, introductory course was designed to provide a mechanism for European auditors to understand the basic requirements for auditing in compliance with Unites States Current Manufacturing Practice for Drugs and Finished Pharmaceuticals and with Quality Systems regulations. The course presents an introduction to the evolutionary process of the regulations and provides a road map for auditors in setting up an audit trail from beginning to end. Specific cGMP compliance aspects in the laboratory and manufacturing operations will be covered. Specific concerns regarding suppliers and vendors will be presented as well. Related topics of validation and computer systems validation are presented as they pertain to the auditing process.
A hands-on workshop will present an opportunity for participants to apply to real life situations the information presented as well as the methodology and techniques learned, by designing and setting up a company cGMP audit program.
The course will consist of lectures, interactive discussions and a hands-on workshop.
Attend this course and its companion course. Surviving an FDA Inspection -- FDA Inspections of Non-U.S. Sites, ID#1880 (Offering # 0806-301) 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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