Webinar on FDA 21 CFR Part 11 Compliance: Streamline Your Transition to Electronic Records
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.
WHO WILL BENEFIT
Engineering personnel
QA
IT
Management
Compliance Officers
Regulatory Affairs
Safety Manager
Document Control
Medical Affairs
SPEAKER
Edwin Waldbusser is a
consultant retired from industry after 20 years in management of development of
medical devices (5 patents). He has been consulting in the US and internationally
in the areas of design control, risk analysis and software validation for the
past 9 years.
Check
out our popular webinars:
2. Identifying Primary and Secondary Causes and Effects - https://tinyurl.com/y3gkowpp
Use Promo Code MKT10N and get flat 10% discount on all purchases
To
Register (or) for more details please click on this below link:
Email:
support@trainingdoyens.com
Toll
Free: +1-888-300-8494
Tel:
+1-720-996-1616
Fax:
+1-888-909-1882
Comments
Post a Comment