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.<br><br>
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.<br><br>
The course consists of lectures, discussions and interactive
workshops with classroom presentations.