Medical Device Trends in FDA Compliance and Enforcement
- Software used with a medical device
- Software-as-a-Medical-Device (SaaMD)
- Software used to manufacture medical devices
- Computer System Validation (CSV)
- Computer Software Assurance (CSA)
- System Development Life Cycle (SDLC) Methodology
- Waterfall, agile, and other methodologies for validation
- Cloud services
- Software-as-a-Service (SaaS)
- Data Integrity
- 21 CFR Part 11, FDA’s Guidance for using Electronic Records and Electronic Signatures (ER/ES)
- FDA Inspection Preparation
- FDA Trends in compliance and enforcement
- Cybersecurity
- IEC 62304
- Q&A
Overview of the webinar
This webinar will focus on medical devices, a key concern for FDA as they become more and more complex, and require methodical risk assessment and mitigation. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could result in injury or death to a patient or consumer. A serious threat, it must be dealt with at all levels to make sure the end product being used by a patient or consumer is perfectly safe and delivers the effective treatment required.
We will look in depth at the current FDA trends related to compliance and enforcement.
Who should attend?
- Information Technology Analysts
- Information Technology Developers and Testers
- QC/QA Managers and Analysts
- Analytical Chemists
- Compliance and Audit Managers
- Laboratory Managers
- Automation Analysts
- Manufacturing Specialists and Managers
- Supply Chain Specialists and Managers
- Regulatory Affairs Specialists
- Regulatory Submissions Specialists
- Clinical Data Analysts
- Clinical Data Managers
- Clinical Trial Sponsors
- Computer System Validation Specialists
- GXP Training Specialists
- Business Stakeholders/Subject Matter Experts
- Business System/Application Testers
- Vendors providing software and services to the medical device industry
Why should you attend?
This webinar is intended for those involved in planning, execution, and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco, and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.). Some of these systems are used in the manufacture and testing of medical device products. Other software products work with medical devices to provide the device functionality. Yet other software is by itself Software-as-a-Medical-Device (SaaMD). We’ll cover all of these and the current trends in the industry, along with best practices for compliance.
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.
