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Leslie Paul, MS

Director, Quality, Advarra Consulting

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

 
Blog

Good Manufacturing Practices: When Do They Apply?

Ensure product quality and compliance in the drug development process. Learn how to optimize your manufacturing processes and maintain key regulatory standards with cGMP best practices from experts.

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3 min. read
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Webinar

Sponsors: Are Your Sites Ready for an FDA Inspection?

Learn a comprehensive overview to prepare sponsors and sites for an FDA inspection.

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Webinar

Don’t Get Caught Off Guard: Inspection Readiness for Sponsors and CROs

Discover strategies for proactively assessing compliance for an FDA Inspection Readiness visit. Address deficiencies and implement corrective actions.

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Webinar

Is Your Site Ready for an FDA Inspection?

Understand the FDA’s expectations for a site inspection, GCP compliance, and maintaining study integrity.

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Webinar

Inspection Readiness: Before. During. After

This webinar will cover successful strategies for a proactive approach to FDA inspections before, during, and after.

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Blog

Q&A: The IND Journey Phase I – Navigating Success

Advarra experts Sharon Ayd and Leslie Paul answer questions from their webinar, The IND Journey Phase I – Navigating Success.

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9 min. read
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Webinar

The IND Journey Phase I – Navigating Success

Explore strategies for advancing investigational new drug (IND) submissions and a comprehensive guide through Phase I of the IND journey.

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Blog

Q&A: FDA Updates: BIMO – What Sponsors Need to Know

Advarra experts Joan Versaggi and Leslie Paul answer questions from the webinar- FDA Updates: BIMO – What Sponsors Need to Know.

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5 min. read
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Webinar

FDA Update: BIMO – What Sponsors Need to Know

This webinar highlights key changes to the compliance program and provides recommended best practices for inspection readiness programs.

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