- TypeWebinar
- Location New York, United States
- Date 13-06-2017
Biotechnology
Overview
We will discuss the importance of applying industry best practices when validating laboratory systems that are regulated by FDA. Any “GxP” system (i.e., the system "touches" product during the laboratory testing or process) must be validated in accordance with FDA guidelines for computerized systems and documented accordingly.
This FDA Compliance course will describe the best practices for conducting validation work, including "who" should be responsible for such tasks and "how" the documentation should be accomplished. FDA guidelines are very specific in terms of how this is to be done.
In addition, we will touch on elements of electronic records and electronic signatures (ER/ES, or FDA 21 CFR Part 11). Specific criteria must be met in order to consider such a signature as valid in the eyes of FDA regulators.
Why Should You Attend
You should attend this webinar if you are responsible for planning, executing or validating a laboratory computer system, or managing the system in a validated state through the end of the system life cycle. The webinar will take you through the validation process, indicating key aspects of the approach, including GAMP 5 System Classification, Risk Assessment and overall development of a sound validation strategy.
The webinar will cover the actual validation phases, deliverables and key points to ensuring the work is in accordance with FDA requirements for computer system validation, while also making sure the approach is cost effective for your organization.
All aspects of the work will be covered, including roles and responsibilities, timing of phases and deliverables, business process reengineering, organizational change management, change control and audit trails, training and documentation. You will also learn what is required not only to validate your laboratory system, but also to maintain it in a validated state until it is retired or otherwise no longer in use.
Areas Covered in this Webinar
Learning Objectives
Who Will Benefit
Professionals in the following subject areas:
For more detail please click on this below link: http://bit.ly/2r9k1XA
Email: [email protected]
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Fax: +1-516-900-5510
This FDA Compliance webinar will discuss the importance of applying industry best practices while validating laboratory systems. Reserve your seat now!
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