Training Doyens

OVERVIEW Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483s at their next inspection. Our upcoming webinar discusses what FDA 21 CFR Part 11 compliance is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. The webinar covers the following key areas: ·          Origin of the FDA regulation and changes in interpretation ·          Electronic records ·          CFR electronic signature LEARNING OBJECTIVES This webinar will explain what FDA 21 CFR Part 11 compliance is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in the FDA regulation will be explained....

OVERVIEW FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient. FDA has set up regulations that address both data security and patient safety. We will show how  FDA 21 CFR Part 11  compliance checklist considers both. The confusion over the original FDA regulation and its subsequent  “selective enforcement ” will be explained. FDA requirements for electronic record and signature validation will be explained. The requirements are composed of technical and procedural aspects. Open, closed and hybrid (paper and electronic) systems will be explained. WHY SHOULD YOU ATTEND Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483’s at their next inspection. Part of this fear originates from confusion. FDA origina...