Compliance4All

Practices to Support FDA Computer System Validation

Compliance4All
Online

132 
*Precio Orientativo
Importe original en USD:
US$ 150

Información importante

Tipología Training
Nivel Advanced
Metodología Online
Duración 1
Inicio Fechas a elegir
Clases virtuales
  • Training
  • Advanced
  • Online
  • Duración:
    1
  • Inicio:
    Fechas a elegir
  • Clases virtuales
Descripción

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
Email: support@compliance4All.com

Instalaciones (1) y fechas
Dónde se imparte y en qué fechas
Inicio Ubicación
Fechas a elegir
Online
Inicio Fechas a elegir
Ubicación
Online

¿Qué aprendes en este curso?

Healthy Eating
Health Management
healthcare
Medical
Medical Trials
Health Ed
Medical services
Course organisation
Online banking management
Training planning

Temario

As a "GxP" system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA's CFR Part 11 guidance on ER/ES must be followed. This webinar will help you understand the FDA's requirements for good documentation, including how to handle change control and the importance of audit trails.

Información adicional

Compliance4All DBA NetZealous161 Mission Falls Lane, Suite 216,Fremont, CA 94539, USA. Phone: +1-800-447-9407Email: support@compliance4All.com
Este curso está en español. Traducir al inglés