Jerry Chapman

Principal, Quality Data & Analytics

Post-Market Intelligence

FDA PreCheck Initiative Draws Strong Industry Reaction at Recent Stakeholder Meeting

December 1, 2025

Conference Spotlight

FDA: A Pillar of Protection for Patients and Industry

April 4, 2025

Enforcement

Limiting Plant Access and Sharing Redacted Documents Results in Import Alert and Warning Letter

January 28, 2025

Biologics Inspection Case Studies Highlight API and Drug Product Deficiencies

December 9, 2024

Enforcement

Granules India FDA 483 Includes Potential Contamination and Data Integrity Findings

November 26, 2024

Trends

MedTech 2024 Highlights: A Look at iCGM Systems and CPAP Machines

November 25, 2024

Conference Spotlight

Facility Issues Top Inspection Deficiencies for Biologics

November 12, 2024

Enforcement

FDA Inspection Shows Systemic Data Falsification Issues

October 11, 2024

Conference Spotlight

Who is Responsible When GMPs Are Not Followed?

October 9, 2024

Conference Spotlight

What is a VAI or OAI Regulatory Meeting?

October 2, 2024

Conference Spotlight

FDA Investigator Attrition Rate Addressed at 2024 PDA/FDA Conference

September 11, 2024

Conference Spotlight

A Glimpse into the Thought Processes of an FDA Expert Investigator

August 28, 2024

Enforcement

Homeopathic Product for Infants Contaminated with Bacteria and Cancer-Causing Lubricant

July 23, 2024

Conference Spotlight

Blatant Data Manipulation and Password Sharing Still Taking Place

June 6, 2024

Conference Spotlight

We Received a 483 After an FDA Inspection – Now What?

May 23, 2024

Conference Spotlight

Infusion Product with TNTC Bioburden Released to the Market

May 20, 2024

Conference Spotlight

How AI Can Reveal Enforcement Trends in Data Integrity

April 25, 2024

Conference Spotlight

A New Drug GMP Mutual Recognition Agreement Model

April 24, 2024