Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Advertising

Event Details

Filter
WorldTraining

21 CFR Part 11 Guidance for Electronic Records - 2018


Add this event to your calendar: iCal   Google Calendar

Who should attend?

Compliance Managers and Auditors Lab Managers and Analysts

Details

Overview:
This includes development of a company philosophy and approach,
and incorporating it into the overall computer system validation
program and plans for individual systems that have this capability.

Why should you Attend:
This webinar will help you understand in detail the application of
FDA's 21 CFR Part 11 guidance on electronic records/electronic
signatures (ER/ES) for computer systems subject to FDA
regulations. This is critical in order to develop the appropriate
validation strategy and achieve the thoroughness required to prove
that a system does what it purports to do.

Areas Covered in the Session:
System Risk Assessment
GAMP 5 "V"Model
21 CFR Part 11
Electronic Records/Electronic Signatures (ER/ES)
Security, Access, Change Control and Audit Trail
Policies and Procedures

Who Will Benefit:
Information Technology (IT) Analysts
IT Developers
IT Support Staff
QC/QA Managers and Analysts

Speaker Profile:
Carolyn (McKillop) Troiano has more than 35 years of experience in
the tobacco, pharmaceutical, medical device and other FDA-
regulated industries. She has worked directly, or on a consulting
basis, for many of the larger pharmaceutical and tobacco companies
in the US and Europe, developing and executing compliance
strategies and programs.

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

http://www.compliance4all.com/control/w_product/~product_id=501843LIVE?channel=pharmiweb_Jun_2018_SEO

Prices

One Dial-in One Attendee Price: $150.00

Contact

Event Manager
support@compliance4all.com

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.