21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , Certificate ,Q/A and 90 mins Live Webinar.


March 22, 2017 at 01:00 PM EST | 12:00 PM CST | 10:00 AM PST

This 90-minute accredited training will bring those interested in the subject matter up to date with the current activities and status of the 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. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.
ER/ES capability can vary, and the approach should be based on the specific case and the risk of failing to meet the guidance associated with it.

Can't Make this LIVE date?
This course will go On Demand on March-23rd...
Simply select the Recorded option when registering and we will send you the link to view the recorded version

Why should you attend :

Attending this presentation will allow you to:
a. Gain an understanding of FDA’s 21 CFR Part 11 Electronic Records/Electronic Signatures (ER/ES) guidance document
b. Develop the ability to apply 21 CFR Part 11 when implementing, validating and maintaining computer systems in your organization
c. Understand the best practices for maintaining a computer system with ER/ES capability in a validated state
d. Discuss the best practices necessary to ensure all systems with ER/ES capability are validated appropriately
e. Learn how to develop the appropriate computer validation strategy, to ensure a good balance of cost vs. risk, as it applies to the use of ER/ES capability
f. Understand how to effectively document the process of computer system validation where ER/ES capability exists, and maintain current information about the various systems in your organization and how they are maintained in a validated state
g. Learn how to gain information about trends in ER/ES validation, as industry progresses and new best practices emerge
h. Understand some of the key “pitfalls” to avoid when employing ER/ES capability.

Areas Covered

-- Computer System Validation (CSV)
-- System Development Life Cycle (SDLC) Methodology
-- Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
-- Validation Strategy
-- System Risk Assessment
-- GAMP 5 “V” Model
-- 21 CFR Part 11
-- Electronic Records/Electronic Signatures (ER/ES)
-- Security, Access, Change Control and Audit Trail


Who will Benefit

-- Information Technology Analysts
-- Information Technology Developers and Testers
-- QC/QA Managers and Analysts
-- Clinical Data Managers and Scientists
-- Analytical Chemists
-- Laboratory Managers
-- Automation Analysts
-- Computer System Validation Specialists
-- GMP Training Specialists
-- Business Stakeholders/Subject Matter Experts
-- Business System/Application Testers
-- This webinar will also benefit any consultants working in the tobacco or life science industries who are involved in computer system implementation, validation and compliance.

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Speaker Profile

Carolyn Troiano

Carolyn 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

Back to Top