HUM-MOLGEN events: Documentation Management and Control

Who Should Attend?
This introductory course is designed for individuals responsible for documentation writing and management in the pharmaceutical and related industries, such as medical device, diagnostics, cosmetics, food, biotechnology as well as vendors, suppliers and contract organizations. 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

Although an introductory course, for more experienced professionals this training can confirm that their existing documentation practices are fully in compliance with the latest regulatory requirements. Also, the course can serve as a useful primer for more advanced related topics such as internal and supplier audits.

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. The course also addresses FDA’s concerns regarding data integrity.

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 case studies. Class size is limited to ensure individual interaction with the instructor. Participants are encouraged to discuss their own needs and challenges regarding documentation.