Medical Device Industry Trends for Computer Systems Regulated by FDA

This Webinar will focus on the importance of managing FDA oversight of computer system validation in the medical device industry by anticipating and preparing for trends. The type and extent of oversight varies with changes to the economic, political, and business environment. FDA funding, the length of government reach into the private sector, and the ability of companies to lobby the government for less regulation all play a role in terms of the dynamics at play between industry and the FDA.

Medical device companies must be vigilant in understanding the factors that impact their ability to operate with oversight from FDA as it relates to computer system validation. In all cases, companies should do the right thing and have robust computer system validation programs that are well executed and documented. However, there are some extremes in oversight that occasionally crop up and may cause expectations to go above and beyond what is considered reasonable. In such cases, companies must determine how much risk to take in terms of the strength of their programs, and how well they are able to negotiate with their FDA auditors.

This webinar is intended for those working in the Medical Device Industry, as well as other FDA-regulated industries, including pharmaceutical, 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 in the Session :
Describe some of the key factors that influence the degree of FDA oversight for computer system validation programs in the medical device industry
Discuss how to anticipate and understand trends in FDA oversight of the medical device industry, as they begin to emerge
Discuss ways for medical device companies to build a solid relationship with FDA and leverage it to gather information about emerging trends
Discuss ways that medical device companies can adjust their computer system validation programs to changes in the regulatory environment
Discuss ways to apply basic computer system validation principles to ensure that in all cases a medical device company is prepared for emerging trends
Provide examples of changes to the factors influencing the regulatory environment and how medical device companies have reacted or responded
Discuss some of the unnecessary risks medical device companies have taken in response to changes in the regulatory environment and the ramifications
Interactive Q&A Session

Who Will Benefit:
Compliance and Audit Managers
Information Technology Analysts
Information Technology Developers and Testers
QC/QA Managers and Analysts
Clinical Data Managers and Scientists
Analytical Chemists
Laboratory Managers
Automation Analysts
Computer System Validation Specialists
GMP Training Specialists
Business Stakeholders/Subject Matter Experts
Business System/Application Testers

Carolyn Troiano

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

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