Computer Systems Validation

OVERVIEW

This will cover the history of Computer Systems Validation in the Pharmaceutical and Medical Device industries. This led to the regulation 21 CFR Part 11, which covers the management of both electronic signatures and electronic records.

Compliance to relevant regulations using Standard Operating Procedures and required documentation will be covered. 

The roles of Audits, Quality Assurance, and Risk Management will also be covered.

WHY SHOULD YOU ATTEND

Changes continue to be implemented in many existing computer systems and in many cases computer systems are being replaced or upgraded using new technologies.  

Many of these changes require Validation and Validation typically involves almost everyone who uses or supports the systems.

Doing Validation is a “Project” that requires participation of many of those involved in the system. Some of this involves strong management commitment to the accuracy and quality of the products of the systems.

AREAS COVERED

• History of Validation Regulations
• Some CSV Standards to use
• Standard Operating Procedures
• Necessary Documentation

LEARNING OBJECTIVES

• Understand Computer Systems Validation
• Cover The role of Electronic Records
• Learn the Compliance to 21 CFR Part 11
• The role of Qualification in Validation
• Preparation of Standard Operating Procedures
• The Documentation needed for Validation

WHO WILL BENEFIT

• IT Staff
• Computer System Users
• Quality Assurance
• Regulatory
• System Vendors

SPEAKER

Richard Chamberlain's experience includes consulting with numerous Pharmaceutical, Contract Research Organizations, and Medical Device companies in the areas of computerized project scheduling, strategic planning, Quality Management and Computer Systems Validation. He has also managed large-scale clinical projects including development of Remote Data Entry systems, Adverse Event reporting, Drug Supplies, project planning and supervision of staffs.