Jerry Chapman

Jerry is Govzilla's Senior GMP Quality Expert. He brings 40 years’ experience in the pharma industry, including 31 years at Eli Lilly where he designed and implemented a comprehensive GMP Intelligence process to identify, analyze, and archive pertinent drug GMP regulations, inspection findings, trends, and best practices in the US and internationally. Jerry was founder and chairman of the GMP Intelligence subgroup of the Midwest Discussion Group from 2005 to 2010.

How Key Pharma and Device Executives Are Developing the Next Generation of Quality Professionals and Leaders

A team comprising over a dozen chief quality officers (CQOs) representing the medical device, pharmaceutical, animal health, and consumer healthcare industries has pooled its collective passion and wisdom – with input from FDA and other drug and device regulatory agencies – to establish and implement an innovative education curriculum that will help develop the next generation of scientists entering the industry.

OCP Guidance

Office of Combination Products Official Details Rulemaking and Guidance Agenda

GMP expert Jerry Chapman covers the presentation by FDA Office of Combination Products (OCP) Associate Director for Policy John Barlow Weiner in which he reviews PMSR guidance and implementation, the RFD process, and new guidance in progress.

NIPP Feature

FDA Expanding its Sterile Drug NIPP Inspection Pilot to Include Other Dosage Forms

FDA is expanding its New Inspection Protocol Project (NIPP) inspection methodology, initially piloted exclusively for sterile drug manufacturing facilities, to include other dosage forms, beginning this month.

Amgen Part 2

Part 2: How Amgen Uses AI Tools To Improve Manufacturing Deviation Investigations

GMP expert Jerry Chapman covers how Amgen is piloting a process using artificial intelligence (AI) that has the potential to greatly enhance its ability to trend and find patterns in manufacturing deviations and to prevent their recurrence.

Amgen AI Part 1

Part 1: How Amgen Uses AI Tools To Improve Manufacturing Deviation Investigations

GMP expert Jerry Chapman covers how Amgen is piloting a process using artificial intelligence (AI) that has the potential to greatly enhance its ability to trend and find patterns in manufacturing deviations and to prevent their recurrence.

CDRH Planned Reorganization Breaks Down Silos and Focuses Expertise by Product Type

CDRH Planned Reorganization Breaks Down Silos and Focuses Expertise by Product Type

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