2016 - Webinar On Medical Device Industry Trends for Computer Systems Regulated by FDA

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