The Certara Blog

Author: Noreen Muscat

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.

Recent Posts

Overcoming Pitfalls and Challenges with Software Validation

As a quality consultant and quality system subject matter expert in the Life Sciences Industry for over 25 years, I have worked for many pharmaceutical companies both large and small and as a consultant with many clients in the pharmaceutical, biotech, and medical device industries. These clients possess a range of experience in software validation—from […]

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