Course offering number:1210-101
Course ID:
1866
Documentation Management and Control
October 1-2, 2012
New Brunswick, NJ
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 various types of documentation be in place. These regulations, however, do not provide any guidance 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.
Attend this course and its companion course
Save $400 off combined regular tuition!
Preparing for and Surviving an FDA Inspection
October 3–4, 2012 • New Brunswick, NJ
Course ID #187