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MEDICAL SPECIALTIES ...

Practices to Support FDA Computer System Validation

From Tuesday, May, 01, 2018 to Tuesday, May, 01, 2018 in CA
Starting from:10:00
Concerned sectors: Biomedical -
DESCRIPTION
Overview:
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:
Computer System Validation (CSV) and the System
Development Life Cycle (SDLC) Methodology
"GxP" - Good Manufacturing, Laboratory and Clinical
Practices
21 CFR Part 11, Electronic Records/Electronic Signatures
(ER/ES)
Data Archival to ensure security, integrity and compliance

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



PUBLIC, SECTORS, ACCREDITATION
Accreditations: 0
Concerned Public: Professional
Attendance: International
Visitors/Participants: 50
Speakers: 1
Exhibitor: n.c
Event Type: Online Conference
Major Sector: BIOMEDICAL
Concerned sectors: Biomedical -
ORGANIZER / ADVERTISER

COMPLIANCE4ALL
161 Mission Falls Lane, Suite 216,
94539 Fremont
UNITED STATES

COMMENT
REFERENCE
Congress, conferences or medical training REF #28-7940
Practices to Support FDA Computer System Validation
Published on congres-medical.com on:2018-03-30 12:14:37
Congress, conferences or medical training in BIOMEDICAL
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