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Leslie Paul, MS
Leslie Paul, MS, is the Director of Advarra Consulting. Paul is a Quality Compliance professional with over 30 years of experience in the FDA-regulated industry. She is a former U.S. FDA Investigator experienced in Drug, Medical Device and Bioresearch Monitoring program inspections. Prior industry roles span the full product lifecycle and include drug discovery, R&D, product development, clinical trials, quality assurance, and auditing. Leslie has successfully championed cross functional and virtual teams to establish and improve quality compliance systems and programs, including quality governance programs, internal, supplier and clinical QA audit programs, inspection readiness, regulatory landscape monitoring and GxP training.
Latest Posts by Leslie Paul
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Good Manufacturing Practices: When Do They Apply?
Navigating cGMP application in investigational drugs can be complex. Learn how FDA guidelines help clinical...
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Sponsors: Are Your Sites Ready for an FDA Inspection?
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and...
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Is Your Site Ready for an FDA Inspection?
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and...
Read More...