Best Practices in Preparation for an FDA Computer System Audit

FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules.

This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit. It will also take into account areas where FDA will likely focus their effort, including on the higher-risk systems.

As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s CFR Part 11 guidance on ER/ES must be followed.

This webinar will focus on the key areas that are most important, including security and data integrity. Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for computer system validation and maintaining data integrity. The life cycle approach takes all aspects of validation into account throughout the life of the system and the data that it houses. The data is a key asset for any FDA-regulated company and must be protected through its entire retention period.

Why you should Attend: In preparation for an audit, it is important to assess the documentation that was prepared when each GxP system was validated to identify and remediate any gaps or issues. The FDA contact person(s) should be able to tell the story of how each system came into Production in a validated state and how each system is maintained in that validated state with the data integrity assured.

It's important to have the right resources and understanding of the process prior to any inspection. Having the validation information available and key resources who can speak to various components of it is critical and should be arranged in advance.

You will learn some tips based on real FDA inspections and lessons learned that will be shared with the audience.

Areas Covered in the Session:

• Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
• Computer Software Assurance (CSA)
• Validation Methodology (waterfall, agile, devops, etc.)
• "GxP" - Good Manufacturing, Laboratory and Clinical Practices
• GAMP®5 Good Automated Manufacturing Practice
• 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
• Data Archival to ensure security, integrity and compliance
• Validation Strategy that will take into account the system risk assessment and system categorization (GAMP V) processes
• Recent FDA findings for companies in regulated industries
• The resources, documentation and room preparation necessary to adequately prepare for inspection
• Q&A

• Information Technology (IT) Analysts
• IT Developers
• IT Support Staff
• IT Security Staff
• QC/QA Managers and Analysts
• Production Managers and Supervisors
• Supply Chain Managers and Supervisors
• Clinical Data Managers and Scientists
• Compliance Managers and Auditors
• Lab Managers and Analysts
• Computer System Validation Specialists
• GMP, GLP, GCP Training Specialists
• Business Stakeholders using Computer Systems regulated by FDA
• Regulatory Affairs Personnel
• Consultants in the Life Sciences and Tobacco Industries
• Interns working at the companies listed above
• College students attending schools and studying computer system validation, regulatory affairs/matters (related to FDA) or any other discipline that involves adherence to FDA regulatory requirements