Validation for new or upgraded software can be time-consuming and challenging. Are you doing too much work to validate your software? Are there ways to streamline the process? Please join us as Noreen Muscat from QACV Consulting discusses common pitfalls in validation and how to avoid them. She will cover topics from GAMP 5 guidelines to CFR Part 11 compliance. Furthermore, Kevin Trimm, Director of Phoenix Technology Services, will share how our latest Validation Suite for Phoenix WinNonlin expedites validation and provides robust reporting.
Who Should Attend?
- Anyone involved in 21 CFR Part 11 system validations
- Validation professionals
- Quality Assurance professionals
- IT professionals supporting Quality systems
About Our Speakers
Noreen Muscat, Senior Quality Consultant, QACV Consulting
Noreen is a quality assurance/regulatory professional with over 18 years of experience in the pharmaceutical/biotech and medical device industry and has provided quality assurance and computer validation consulting services since 2012. Her vast industry cross-functional and GAMP experience led her to be the Quality System subject matter expert (SME) for previous FDA and EU audits. Noreen has successfully implemented, validated, and launched many electronic technologies for both large and small companies with an emphasis on training, safety, compliance, and validation.
Kevin Trimm, MS, Director of Phoenix Technology Services
Kevin leads the services team at Certara, implementing Phoenix software and providing customized solutions. Prior to joining Certara, Kevin worked for 14 years in pharmaceutical contract research, primarily at Charles River Laboratories, where he was the global head of the Pharmacokinetics and Statistics departments. Kevin also co-founded Montreal Pharmacokinetics Inc., a GLP accredited contract research organization specializing in pharmacokinetic analysis, reporting, and consultation. Kevin’s bachelor and master’s degrees were focused on cognitive and neurological sciences. He continued his graduate education in pharmacology and biostatistics at McGill University.