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Best Practices to Support FDA Computer System Validation

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Category Computer System Validation, 21 cfr part 11 validation, computer system validation in pharmaceutical, fda 21 cfr part 11, computer system validation guidelines

Deadline: August 05, 2018 | Date: August 07, 2018

Venue/Country: Online, U.S.A

Updated: 2018-06-07 14:30:17 (GMT+9)

Call For Papers - CFP


We will cover the importance of maintaining the documentation

from every computer system validation effort in a "current" state.

The system must be maintained in a validated state throughout its

entire life cycle, and the accompanying validation documentation

must also be maintained.

Why should you Attend:

This session will address the specific way of documenting your

computer system validation work to ensure it meets FDA

requirements and can pass an inspection. There are specific

requirements that must be followed in order for the Agency to

consider the documentation valid, and without following these,

there is a great risk of invalidating work.

Areas Covered in the Session:

21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)

Data Archival to ensure security, integrity and compliance

Learn the requirements for documenting efforts related to systems

governed by FDA

Discuss the best practices for documenting computer system

validation efforts, including requirements, design, development,

testing and operational maintenance procedures

Who Will Benefit:

Information Technology Analysts

Information Technology Developers and Testers

QC/QA Managers and Analysts

Analytical Chemists

Laboratory Managers

Automation 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


Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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