Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization.  Following best practices for developing a validation program that includes planning, execution and maintenance components will ensure that these efforts will meet all regulatory agency requirements and expectations.  Preparedness will improve your relationship with the agency and ensure a more cooperative and successful audit experience.

FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules.  You’ll learn all about how to prepare your system validation documentation for an FDA audit of your company’s computer systems.

It is not enough just to validate a computer system and defend your approach to regulatory agencies.  You will also need to ensure that the data and information collected, analyzed and reported using the system can be defended effectively, as well.  In this course, you will learn how to apply industry best practices to ensure that you and your system users and other stakeholders are fully prepared to defend your systems, data and information to regulatory agencies.  At the same time, you will learn how to do this in the most cost-effective manner.

Course Objectives:

This webinar will cover the following key areas:

• Learn about 21 CFR Part 11 and what is required for compliance
• Learn about industry best practices related to compliance and computer system validation
• Understand strategies for reducing the cost and complexity of compliance with FDA regulations, including 21 CFR Part 11
• Understand how the System Development Life Cycle (SDLC) methodology supports the computer system validation process
• Understand how to effectively document the process of computer system validation, and maintain current information about the various systems in your organization and how they are maintained in a validated state
• Learn how to gain information about trends in validation, as industry progresses and new best practices emerge
• Understand some of the industry best practices to apply when following the SDLC methodology

Why Should You Attend:

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization.  You should attend this seminar if you are responsible for planning, executing or managing a computer system that is governed by FDA regulations.  A full understanding of how to categorize such a system and assess the potential risk, should the system fail, are key to ensuring this process will be adequate.

This webinar will provide you with the best industry practices to ensure that you are inspection-ready when FDA plans an audit of your computer systems that are regulated by them.  The tips and suggestions offered during the webinar will be helpful in organizing, preparing, communicating, executing, and documenting all audit-related activities, and in dealing with FDA directly.

Course Outline:

• Computer System Validation Compliance Audit by FDA
• FDA Audit
• Inspection Readiness
• Computer System Validation (CSV)
• System Development Life Cycle (SDLC) Methodology
• Good “Variable” Practice (GxP)(Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
• Validation Strategy
• System Risk Assessment
• GAMP® 5 System Categorization Approach
• GAMP® 5 “V” Model
• GxP Documentation
• Good Documentation Practices (GDPs)

Upon completion of this session, attendees will have an understanding of computer system validation planning, execution and management concepts, in terms of how these efforts are to be adequately documented to meet FDA requirements and help you succeed during any FDA computer system validation audit or inspection.  Attendees will understand the steps required for documenting the validation process, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs.  The attendees will have a good grasp of how to leverage these practices across all systems by creating a standardized program.

NOTE: GAMP® is a registered trademark of ISPE. To learn more about GAMP®, visit www.ispe.org