Principles of Good Documentation

Documentation is an essential part of Good Manufacturing Practice (GMP). This course provides an overview for manufacturers of pharmaceutical and biological products of the documents required and the controls that should be in place. The regulatory requirements of FDA are addressed with reference also made to the requirements of the EU. The course provides an introduction to staff at all levels and highlights the personal responsibility they have for ensuring documentation is followed and documentation is correct. Topics in this course include: Regulatory Requirements, Instructional Documents, Records, Control, Electronic Documentation, and Good Practices. After completing this course, learners will be able to recognize the importance of good documentation practices.