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CfPA - The Center for Professional Advancement, Burlingame, CA
April 4-5, 2011
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 introductory 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. Attend this course and its companion course
Save $400 off combined regular tuition!
Preparing for and Surviving an FDA Inspection
April 6–7, 2011 • DoubleTree Hotel, Burlingame Course ID #187
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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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sberg@cfpa.com
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