Since the COVID-19 pandemic began, the pharma/biopharma and medical device industries have switched to remote audits in lieu of traditional onsite audits.  This has required firms and regulatory agencies to tackle new approaches. 

Recognizing this, Redica Systems hosted a virtual panel discussion Tuesday, May 18 at 1:30 p.m. EST on remote audits.  A panel of experts shared their thoughts and perspectives on remote audits. 

The virtual panel is available for download here.

Remote Panel Discussion

Who Will Benefit?

This session will be valuable to GMP quality, regulatory, compliance, and management personnel in FDA-regulated industries who want to have a conversation on remote audits and get to know what is going on in the industry.

About the Panelists

Barbara Unger

Barbara Unger formed Unger Consulting, Inc. to provide GMP auditing and regulatory intelligence services to the pharmaceutical industry.  Her auditing experience includes leadership of the Amgen corporate GMP audit group for APIs and quality systems.  She also developed, implemented, and maintained the GMP regulatory intelligence program for eight years at Amgen.

Jerry Chapman

Jerry Chapman is a Senior GMP Quality Expert at Redica Systems.  He writes the Redica Systems blog “Conference Spotlight” and is working on machine learning models for analysis of agency enforcement documents.  He brings 40 years’ experience in the pharma industry, including 31 years at Eli Lilly in technical and leadership positions in research and product development, manufacturing, plant quality, site quality, corporate quality, and quality systems.

Stephanie Gaulding

Stephanie Gaulding is the Executive Director, Regulatory Compliance at Pharmatech Associates, Inc., a consultancy serving the regulated life science industry.  She draws on over 25 years of experience in quality management systems and leadership roles in the regulated life science industry to develop and deliver efficient and sustainable quality management systems, assuring compliance with global regulatory requirements and industry best practices.

Jason Kerr

Redica Systems Senior GXP Specialist Jason Kerr will moderate the panel.

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