Medical Device Software 62304 Compliance

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Hear By Carolyn Troiano industry reviewer for 21 CFR Part 11, the FDA’s (ER/ES) regulation. along with computer system validation and risk management/compliance at a number of Fortune 100 firms."

IEC 62304 provides a standard for design

Description

This webinar will focus on medical devices, IEC 62304, and what is required for compliance.
Medical devices can use very complex software applications, and any failure to function properly could lead to potential injury or death of a consumer or patient.
There is a need to improve overall standards for medical device software to account for this high risk potential.
The majority of software recalls in the 1990s were due to software defects that were a result of software being upgraded.
There is a need to restructure medical device software development processes, and adopting IEC 62304 provides a standard for design that is accepted in the United States (US) and European Union (EU).
IEC 62304 is a risk-based approach to compliance that ensures the standards followed are appropriate for their potential assessed risk.
IEC 62304 is a lifecycle approach that defines the activities and tasks required to ensure software for medical devices will be safe and reliable.
Applying IEC 62304 will reduce your overall rate of software failure and improve your bottom line.

Why should you attend

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.
You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system.

Areas Covered

•       Providing safe and effective medical devices is in the best interests of all those involved in developing software            for these products, and for those involved in developing medical devices that use software. 
•         This session will provide insight into the IEC 62304 standard as it is applied to medical device software.
•         You will learn how to apply this standard to your own work processes.
•         You will also gain insight into the current industry best practices that will help you with IEC 62304 compliance.
•         Q&A

Who will Benefit

Professionals in the following industries may also benefit from the content:
•         Pharmaceutical
•         Medical Device
•         Biotechnology
•         Tobacco and Related (Vapor, e-Cigarette, Cigar, etc.)
•         Any other FDA-regulated industry, plus any Life Science Consulting or Contracting firm
•         Information technology managers and analysts
•         QC/QA managers and analysts
•         Clinical data managers and scientists
•         Compliance managers
•         Lab managers and staff
•         Automation analysts
•         Computer system validation specialists
•         GMP training specialists
•         Business stakeholders and individuals who are responsible for computer system validation                                           planning, execution, reporting,compliance, and audit                                                    
•         Consultants working in the life sciences, tobacco and related industries who are involved in computer system              implementation, validation and compliance
•          Anyone involved in the planning, execution, and reporting of a clinical trial (sponsor, director, researcher,                    regulatory role, etc.)

Industries who can attend

This 90-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Carolyn Troiano

Carolyn Troiano has more than 35 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.

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