Webinar On Computerized System Validation: Basic Concepts

Description :

The basic concepts of computerized system validation originated in the 1960s, with the Department of Defense and NASA. Validation of systems became a growing issue within the pharmaceutical industry during the late 1980s and early 1990s, as the use computerized technologies became commonplace in the research and manufacturing of drug products. The FDA issued a series of regulations and guidelines to define regulatory expectations for computerized system validation. In today’s pharmaceutical environment, virtually all aspects of research and manufacturing are conducted using computerized systems, yet the planning, conduct, and necessary controls for validation of these systems remains problematic for many companies and industry professionals.

Areas Covered in the Session :

Introduction, Historical Perspective, and Definitions

Computerized System Validation Master Plan

Validation Plan

Developer Assessment

Requirements, Design, and Configuration Specifications

Validation Testing

Procedures/Archival/Traceability

Validation Summary Report

Commissioning Memo

System Decommissioning/Retirement

Questions & Answers

Who Will Benefit:

Recommended webinar for FDA regulated companies, any staff members who may be involved with computerized system validation project planning, validation testing, system use, system support, and regulatory compliance of computerized systems. Professionals who will benefit are:

Project Management

Strategic Management

Quality Assurance staff

IT staff

Operations staff

Price Tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

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https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=IT1395

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