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Validity : 09th Nov'24 to 19th Nov'24
Medical Device Trends for Computer Systems Regulated by FDA
- Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
- GxP - Good Manufacturing, Laboratory and Clinical Practices
- 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
- Medical Devices, including hardware and software
- Data Archival to ensure security, integrity and compliance
- Recent FDA commentary on medical devices
- Recent FDA findings for companies in the medical device industry
- Validation Strategy that will take into account the system risk assessment and system categorization (GAMP V) processes
- Focus on Real-World Data (RWD) and Real-World Evidence (RWE)
- Post-Market Surveillance and Med Watch Reporting
- Focus on Quality
- Q&A
Overview of the webinar
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will leave you with the information:
- You will learn about the Center for Devices and Radiologic Health (CDRH) Learn, FDA’s innovative educational tool, which consists of learning modules describing many aspects of medical device product regulations, covering both premarket and post-market topics. This tool is intended to provide industry with information that is comprehensive, interactive and easily accessible
- We will talk about the various initiatives taken up by FDA in the recent past to better protect human health in the use of medical devices. There is a focus on quality and on post-market surveillance that should feed into the Med Watch Reporting program
- We will talk about recent issues that have brought about changes to FDA guidance documents, some still in draft, with others having been finalized
Who should attend?
- Information Technology Analysts
- 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 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 webinar will help you understand the FDA’s current thinking on medical devices as they are used as or in conjunction with, computer systems that are regulated by FDA. 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.
Faculty - Ms.Carolyn Troiano
Carolyn Troiano has more than 30 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.