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Validity : 21st Jul'25 to 31st Jul'25
Trends in FDA Compliance and Enforcement for Regulated Systems
- Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
- “GxP” – Good Manufacturing, Laboratory and Clinical Practices
- Validation Planning, Execution and Reporting
- Maintaining a System in a Validated State
- 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
- Data security, integrity and compliance
- Validation Strategy that will take into account the system risk assessment and system categorization (GAMP°5) processes
- COTS, cloud and SaaS environments
- Recent FDA findings for companies in regulated industries
- Recent trends in technology that need to be addressed in the validation approach
Overview of the webinar
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.
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 electronic signatures (ER/ES), as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment. FDA recently issued a new draft guidance for use of ER/ES in clinical investigations.
More recently, the FDA has brought tobacco products under their regulatory jurisdiction, and has applied guidelines for validation of computer systems used in the manufacture, testing or tracking of tobacco-related products. This includes cigarettes, cigars, e-cigarettes and other forms of smokeless tobacco, such as “pouch” products.
The guidance on validation has been modified with the FDA’s proposed draft guidance for Computer Software Assurance (CSA) in September 2022. Addressing the approach to software development, testing and release this includes Agency support for use of agile as an SDLC methodology, along with other non-linear approaches. It also opens the door to consider use of Artificial Intelligence (AI), Machine Learning (ML) and a host of other technologies in FDA-regulated systems. The intent is to avoid creating a huge regulatory compliance cost to industry that has prevented companies from embracing these innovations.
Along with CSA, GAMP®5, 2nd Edition was published in July 2022 and aligns well with the proposed draft from FDA. Both focus on critical thinking and following a risk-based approach to testing. Both are intended to improve efficiency and effectiveness of validation work.
This session will provide some insight into current trends in compliance and enforcement. Those based on technology changes, and these will continue to have an impact as new innovations come into use in the industry.
Who should attend?
Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GxPs:
- Pharmaceutical
- Medical Device
- Developers of Software Used with Medical Devices
- Biologicals
- Tobacco (based on the Tobacco Control Act of 2009)
- E-Liquid/Vapor (based on the “Deeming” Act of 2016)
- E-Cigarette (based on the “Deeming” Act of 2016)
- Cigar (based on the “Deeming” Act of 2016)
- Third-Party companies that support those in the above industries, including Contract Research Organizations (CROs)
- Colleges and Universities offering programs of study in Clinical Trial Management and Regulatory Affairs/Matters related to FDA
Personnel in the following roles will benefit:
- Information Technology (IT) Analysts
- IT Developers
- IT Testers
- IT Support/Maintenance
- QC/QA Managers
- QC/QA Analysts
- Clinical Data Managers
- Clinical Data Scientists
- Analytical Chemists
- Compliance Managers
- Laboratory Managers
- Automation Analysts
- Manufacturing Managers
- Manufacturing Supervisors
- Supply Chain Specialists
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders (Subject Matter Experts, or SMEs) responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
- Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
- Auditors engaged in the internal inspection of labeling records and practices
Why should you attend?
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.
- Provide an overview of FDA computer system validation requirements, including 21 CFR Part 11 compliance and data integrity
- Provide an overview of recent trends in FDA compliance and enforcement relative to computer system validation, including citation areas of focus
- Provide a set of best practices and industry standards to meet FDA compliance requirements for computer system validation
Faculty - Ms.Carolyn Troiano
Carolyn Troiano has more than 40+ years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.
During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA's electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.
Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI's Educational Fund as a project management instructor for non-profit organizations.