Trends in FDA Compliance and Enforcement for Regulated Systems

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.

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: FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. This guidance was first issued in 1983, and the main points of focus remain consistent today, despite the number of years that have passed and the technology changes that have taken place.

The guidance was revisited for its application to the medical device industry, as the first issuance addressed pharmaceuticals. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment. This guidance has been modified over the years to make it more palatable to industry, and this includes discretionary enforcement measures. The intent was to avoid creating a huge regulatory compliance cost to industry that was initially preventing companies from embracing the technology.

This session will provide some insight into current trends in compliance and enforcement. Some are based on technology changes, and these will continue to have an impact as new innovations come into use in the industry.

Areas Covered in the Session:

• Learn about Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
• Learn about the importance of doing a risk assessment of all FDA-regulated systems
• Learn about the importance of categorizing your FDA-regulated software according to GAMP®5 guidelines
• Understand “GxP” Systems
• Understand various methodologies (waterfall, agile, devops, etc.) and how to apply them successfully for validation of regulated computer systems
• Understand 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
• Learn how data backup, recovery, and governance play a key role in ensuring security, integrity and compliance of FDA-regulated computer systems and data
• Learn how to develop a solid Validation Strategy that will take into account the system risk assessment and system categorization (GAMP®5) processes
• Learn about recent FDA findings for companies in regulated industries, specifically related to computer systems, validation, 21 CFR Part 11 and data integrity
• Understand the latest guidance from FDA on data integrity (ALCOA+ Principles)
• Learn about recent trends in technology that need to be addressed in the CSV approach
• Learn about industry best practices for becoming inspection ready
• 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