Course offering number:1003-403
Course ID:
1866
Documentation Management and Control
22-23 March 2010
Amsterdam, The Netherlands
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 basic 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.