The Center for Professional Advancement, New Brunswick, NJ
October 2-3, 2007
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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