Faculty Development Program Information


21 CFR Part 11 Guidance for Electronic Records - 2018


Faculty Development Program Title
21 CFR Part 11 Guidance for Electronic Records - 2018
Event Type
Faculty Development Program
Faculty Development Program Date
21-06-2018
Last Date for Applying
20-06-2018
Location
Fremont, California, United States

Organization Name / Organize By
Netzealous LLC DBA - Compliance4All
Organizing/Related Departments
Compliance Trainings & Seminars for all Industries
Organization Type
Organization/Company
Faculty Development Program Category
Both (Technical & Non Technical)
Faculty Development Program Level
All (State/Province/Region, National & International)
Related Industries

Education/Teaching/Training/Development

Manufacturing

Location
Fremont, California, United States

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=eventsget_Jun_2018_SEO

Registration Fees
Available
Registration Fees Details
One Dial-in One Attendee Price: $150.00
Registration Ways
Other
Address/Venue
Online  Pin/Zip Code : 94539
Official Email ID
support@compliance4All.com
Contact
Event Manager

Online

support@compliance4All.com

     +1-800-447-9407
   Fax No: 302-288-6884