21 CFR Part 11 Conformance for Medical Devices
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 21 CFR part 11 considers both.
The
confusion over the original FDA regulation and its subsequent “selective
enforcement” will be explained. FDA requirements for 21 CFR Part 11 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
originally published a rather severe 21 CFR Part 11. After industry complaints
the FDA acknowledged that the regulation, as written, would result in nobody
attempting to convert to electronic records. But, instead of rewriting the regulation,
FDA said it would “selectively enforce” sections of the regulation.
This
webinar will explain what all of this mean. An FDA 21 CFR part 11 compliance
checklist and a Test protocol form will be given as handouts.
AREAS
COVERED
Origin
of the FDA regulation and changes in interpretation ; electronic records; CFR
electronic signature; data security; open, closed and hybrid systems;
validation methods; risk analysis.
LEARNING
OBJECTIVES
This
Webinar will explain what is FDA 21 CFR part 11 compliance, 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.
WHO
WILL BENEFIT
- Engineering
personnel
- QA
- IT
- Management
For more detail please click on this below
link:
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