Webinar on FDA Compliance and Laboratory Computer System Validation

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Category Food, Drugs & Biologics

Deadline: July 27, 2106 | Date: July 27, 2106

Venue/Country: Online, Canada

Updated: 2016-06-30 18:47:08 (GMT+9)

Call For Papers - CFP

Areas Covered in the Session :

Gain an understanding of laboratory system computer validation planning, execution and management concepts

Discuss the best practices for laboratory computer system validation that will ensure compliant results while minimizing costs

Identify the GAMP 5 category for the system to understand how best to approach validation, particularly testing

Discuss the key documentation associated with validating laboratory systems and maintaining them in a validated state, while minimizing costs

Learn how to leverage these practices across all systems by creating a standardized program for FDA-regulated systems

Understand the training that must be provided to business and IT staff involved in the validation process

Discuss the business process re-engineering opportunities that might be leveraged as a system is implemented, particularly if it is more advanced than the legacy system in terms of technology and functionality

Learn the advantage of incorporating a formal organizational change management system into the validation effort to ensure that users fully embrace the new technology and functionality

Who Will Benefit:

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Professionals who will benefit include:

Information Technology Analysts

Information Technology Developers and Testers

QC/QA Managers and Analysts

Analytical Chemists

Compliance and Audit Managers

Laboratory Managers

Automation Analysts

Computer System Validation Specialists

GMP Training Specialists

Business Stakeholders/Subject Matter Experts

Business System/Application Testers

Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.