Documentation Management and Control
Label
Label
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 also
benefit individuals in a variety of functions such as:
• QA/QC
• Regulatory
• Auditing
• Production
• R&D
• Product Development
• Toxicology
• Vendors/Suppliers
• Clinical Research
• CRO’s
Description
Regulations such as Good Manufacturing Practice for drugs
and medical devices, Good Laboratory Practice, Good Clinical
Practice, 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 up 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 systems that require
documentary coverage. It also covers the design,
implementation and management of such documentation
systems to ensure continuous compliance.
Types of documentation addressed include: quality manuals,
policy manuals, standard operating procedures, work
instructions, forms, records, etc. The course also addresses
aspects of 21 CFR Part 11—Electronic Records and
Signatures.
The program consists of lectures, discussions and interactive
workshops with classroom presentations.
SAVE $400!
Take this course and its Companion Course:
Surviving an FDA Inspection -- FDA Inspections of Non-U.S. Sites
5-6 June 2012, ID# 1880, Offering# 1206-202 and save $400 off the combined Regular Registration tuition