Medical Device 2012 - Good Documentation Practices for GXPs

This webinar on Good Documentation Practices will review the FDA requirements for documenting data in preclinical and clinical studies and manufacturing activities.

The FDA continues to cite documentation errors and omissions as one of its main findings during investigations. These errors take either of two forms:

Continual and repeated "small" documentation errors.
Critical documentation errors that affect the integrity of the study or batch records.