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The Center for Professional Advancement, Amsterdam, The Netherlands
17-18 March 2008
Who Should Attend
This basic introductory course is designed for individuals responsible for documentation writing and management in the pharmaceutical and related industries. The course will benefit individuals in a variety of functions such as:- Quality Assurance
- Regulatory
- Quality Control
- Production
- R&D
- Product Development
- Toxicology
- Vendors/Suppliers
- Clinical Research
- CRO’s
Description
FDA regulations such as Good Manufacturing Practice (GMP) for drugs and medical devices, Good Laboratory Practice (GLP), Good Clinical Practice (GCP), as well as quality system standards like ISO 9000, require that documentation, such as standard operating procedures, plans and various types of records, be in place. These regulations, however, do not provide any guidelines to the industry on how to set up and manage documentation systems. It is, therefore, left to companies to design and set up their own internal documentation systems.
This course provides hands-on methodology and techniques on how to identify what systems require documentary coverage; how to flowchart operations to identify what type of documentation is required; and how to set up, implement and manage the maintenance of such documentation systems to ensure continuous compliance. Types of documentation addressed include: quality manuals, policy manuals, standard operating procedures, work instructions, forms, records, logs, protocols, etc. The course also covers areas related to computer validation documentation, such as validation protocols and 21 CFR Part 11—Electronic Records and Signatures. Emphasis is placed on controls that need to be in place to ensure proper manipulation of documentary systems.
The course consists of lectures, discussions and interactive workshops with classroom presentations.
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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.
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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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