2020 - Medical Device Trends for Computer Systems Regulated by FDA

Topic :Medical Device Trends for Computer Systems Regulated by FDA
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Overview:
Pharmaceutical, biological, vaccine, medical device, tobacco and other companies regulated by FDA must be vigilant in understanding compliance and enforcement by the Agency as it relates to computer system validation (CSV). In all cases, regulated companies should do the right thing and have robust computer system validation programs that are well executed and documented in order to meet the strict guidelines set forth by FDA.
Areas Covered in the Session :
Describe the various components of computer system validation compliance required by FDA
Understand the most critical aspects of computer systems to be scrutinized by FDA during reviews and audits
Discuss ways to anticipate and prepare for FDA scrutiny
Determine how identify and select the best course of action taken when responding to an FDA finding, warning or consent decree
Describe some of the key factors that influence the degree of FDA enforcement for computer system validation programs in the GxP regulated industries
Discuss ways to apply basic computer system validation principles to ensure that in all cases a regulated company is prepared for emerging trends
Provide examples of enforcement actions by FDA in industry, how companies have responded, and identify the best practices
Q&A
Speaker:
Carolyn Troiano is Keynote Speaker at ComplianceKey.She has more than 30 years of experience during which she worked directly, or as a consultant, for many top-tier pharmaceutical, medical device and biological companies in the US and Europe. She was responsible for computer system validation compliance activities across all GxP functions at a major pharmaceutical company. She developed computer system validation programs and strategies and was an industry reviewer for 21 CFR Part 11, the FDA's electronic record/electronic signature (ER/ES) regulation.
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