IT Systems Validation for FDA Regulated Industries

Software validation is not just a regulatory necessity. It is fast becoming a necessity for the device industry’s increasingly software-controlled environments.

Many companies struggle with understanding how to avoid major mistakes and inspection risk when validating software to FDA standards. This webinar will review the validation planning process with emphasis on avoiding common pitfalls. The attendee should leave the presentation confident in their ability to improve the level of validation success.

If data becomes invalid, based on improperly validating and maintaining the system that houses it in a validated state, the work related to the data would need to be repeated. This could result in a devastating loss to a company.
Learn how to develop the appropriate IT systems validation strategy.

Understand how to effectively document the process of IT systems validation, and maintain current information about the various systems in your organization. We will discuss the key areas that are most important during inspection and audit, including security, data integrity, validation, training, and documentation

Why You Should Attend:

This webinar will focus on how to properly validate FDA regulated IT systems in order to ensure that security and data integrity objectives are met and FDA enforced compliance is met. We will discuss IT Systems Validation approach based on FDA requirements.

We will walk through the entire System Development Life Cycle (SDLC) approach to validation of FDA-regulated computer systems, and will also discuss 21 CFR Part 11, European equivalent Annex 11, GAMP 5 which deal with controlling risk and managing computer systems over their life cycle including validation. We will discuss what is needed to prepare for an FDA inspection of computer systems and data.

Learning Objectives:

• Learn how to identify “GxP” Systems
• Learn about the System Development Life Cycle (SDLC) approach to validation
• Learn best practices for documenting IT system validation efforts, including requirements, design, development, testing and operational maintenance procedures
• Understand how to maintain a system in a validated state through the system’s entire life cycle
• Learn about the policies and procedures needed to support your validation process
• Learn how to best prepare for an FDA inspection or audit
• Lean clinical trial related IT systems validation

Areas Covered in the Session :

• GxP/GMP Systems
• FDA Regulatory Oversight over IT systems validation
• Regulations: 21 CFR 11, Annex 11, GAMP 5
• System Development Life Cycle (SDLC) approach to validation
• Documenting IT Systems validation efforts
• Policies and procedures needed to support the validation process
• FDA audit preparedness as far as IT systems validation is concerned
• Risk based approach to validation
• Clinical trial related IT systems validation

Who Should Attend:

• Quality Assurance Departments
• Quality Control Departments
• Research and Development Departments
• Regulatory Affairs Departments
• Compliance Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Production Departments
• Validation Departments
• IT Departments and Systems Administrators
• Documentation Departments
• Laboratory Departments

Course Director: ELEONORA BABAYANTS

Eleonora Babayants is a Galaxy Consulting Founder and President, She is a documentation management professional and hands-on consultant with over 25 years of experience in documentation and records management, document control, regulatory compliance, internal and external auditing, electronic document management systems, information governance, and change management. Eleonora's past work includes development and implementation regulatory compliance processes and procedures, leading implementation and administration of document control systems in full compliance with regulatory requirements, enabling enterprise search, improving systems information architecture, creating and implementing users training programs. She led electronic document management systems selection and deployment, administered and supported these systems, web information portals, knowledgebase applications, recommended and implemented re-structuring of the content and the information architecture of these systems. She worked very closely with IT to do feasibility assessment and to capture users' requirements. She wrote technical documents and created documents templates. Eleonora's experience spans multiple industries including biomedical, pharmaceutical, and medical devices companies.