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Validation Made Easier! Tips and Guidance from the Experts

On-Demand Webinar

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, Allan Michaels, Sr. Project Manager 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.

Allan Michaels, Sr. Project Manager, Phoenix Technology Services

Allan manages projects for the services team at Certara, implementing Phoenix and PKS software solutions for customers worldwide. Prior to joining Certara, Allan worked 15 years in the pharmaceutical industry, most recently at Sanofi-Aventis, where he was Sr. Project Manager and solutions architect for the global Pharmacokinetics and Data Management System. As a member of the Phoenix Technology Services team he has performed numerous validations of PKS and Phoenix.

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? In this webinar, Noreen Muscat from QACV Consulting discussed common pitfalls in validation and how to avoid them. She covered topics from GAMP 5 guidelines to CFR Part 11 compliance. Furthermore, Allan Michaels, Sr. Project Manager of Phoenix Technology Services, shared how our latest Validation Suite for Phoenix WinNonlin expedites validation and provides robust reporting.

Who Should Watch?

  • Anyone involved in 21 CFR Part 11 system validations
  • Validation professionals
  • Quality Assurance professionals
  • IT professionals supporting Quality systems
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