Based on GxP/GMP requirements, FDA requires that all computer systems that handle data regulated by FDA be validated in accordance with their guidance on computer systems. This is critical to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement. When used as intended, IT systems validation can provide increased process reliability, confidence, improved performance, and reduced operating expenses.
Why Should You Attend:
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.
Learning Objectives:
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.
Attendees will:
- 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
- Learn clinical trial related IT systems validation
Areas Covered in the Webinar:
- 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
Instructor Profile:
Eleonora Babayants, Galaxy Consulting Founder and President, has many years of GxP/GMP hands-on experience in regulated industries. She worked with quality assurance and compliance officers to develop and execute compliance strategies and programs. She participated in the implementation of compliance requirements.
Her many years’ experience includes regulatory compliance, internal and external auditing, change management, documentation and records management, document control, electronic document management systems, information governance, IT systems management and validation.
Eleonora’s past work includes development and implementation of regulatory compliance policies, processes, and procedures, leading implementation and administration of document control and document management systems in full compliance with regulatory requirements, designing and implementing electronic documents workflows, leading enterprise content management initiatives, enabling enterprise search, improving systems information architecture, creating and implementing users’ training programs.
Eleonora ensured document management systems compliance with regulatory requirements. She collaborated with users to develop positive and productive approaches to regulatory compliance, coordinated, prepared, and participated in internal and external audits including FDA audits.
Eleonora’s experience spans multiple industries including biomedical, pharmaceutical, and medical devices companies.