Management of GxP Documentation Training
Documentation is most important in the regulated world. "If it is not documented, it is rumor" is a famous saying when dealing with FDA and other agencies. "Documentation not available", or "Documentation not adequate" are most frequently cited deviations in FDA Warning Letters. With a good understanding of the regulations, good common sense, good science or good engineering it is easily possible to be in compliance with technical requirements, however to comply with documentation is not so easy. It is not enough, to have everything documented, it is equally important to have the right documents with the right format.
Good Documentation Practices are the set of activities that enable you to record your raw data and hand-written entries in a legible, traceable and reproducible manner. Compliance with FDA’s GLP regulations (21 CFR Part 58), as well as GMP regulations (21 CFR Part 211), requires the use of Good Documentation Practices.
An introduction to the control and management of GxP Documentation. Ideal for new starters or equally as a refresher for those having worked in a GxP Regulated Environment before. The Management of GxP Documentation training course is also a useful precursor to the Electronic Document Management Systems (EDMS) Module.
