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In light of the pandemic situation events until September 2021 are cancelled. We will inform customers directly when the events are rescheduled.    
COVID CANCELLED: Project Management in Human Resources,   Boston MA, Jan 6-8, 2021
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Following events are tentatively planned but may be rescheduled, based on CDC guidelines or attendee registration interest .    
TENTATIVE: 21 CFR Part 11 Compliance,   Boston MA, Sep 22-24, 2021
TENTATIVE: Quality Control Laboratory Compliance,   Boston MA, Oct 6-8, 2021
TENTATIVE: Analytical Instrument Qualification and System Validation,   Boston MA, Nov 15-17, 2021
TENTATIVE: FDA's New Import Program for 2021,   Boston MA, Dec 7-9, 2021

Boston Professional Events List


Compliance for Computer Systems Regulated by FDA - 2020


Date
Oct 12, 2021 - 10:00 AM
Organizer
Netzealous LLC DBA - Compliance4All
Venue
Online Event
Location
Netzealous LLC DBA - Compliance4All,

Fremont,
CA,
US,
ZIP: 94539
Phone: 18004479407

Ticket Price: $ 150.00
Overview:
The Webinar will focus on the importance of ensuring that electronic
record/electronic signature (ER/ES) capability built into FDA-regulated
computer systems meets compliance with 21 CFR Part 11. 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.

Areas Covered in the Session:
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:
Clinical Data Managers and Scientists
Analytical Chemists
Laboratory Managers
Automation Analysts
Manufacturing and Supply Chain Managers and Analysts
Computer System Validation Specialists

Speaker Profile:
Carolyn (McKillop) 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.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

Event Categories
Keywords: computer, FDA, medical




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