Jerry Chapman

Principal, Quality Data & Analytics

Conference Spotlight

Antibiotic-Resistant Bacteria in Patients Is a Genetic Match to Product Contaminant

April 19, 2024

Conference Spotlight

Health Canada Remote/Virtual and Hybrid GMP Inspections – and Which Your Facility May Expect

April 11, 2024

Health Canada and TGA Reduce Regulatory Burden for Some Drug Company Approvals

April 9, 2024

Conference Spotlight

Drug GMP Warning Letter Issued Without Facility Inspection

November 20, 2023

Conference Spotlight

FDA Post-Warning Letter Meetings are Not Agency Consultations

September 25, 2023

Conference Spotlight

A Deep Dive into Cell and Gene Therapy Regulatory Considerations: Part Four

August 2, 2023

Enforcement

Internal Audit Reports: Can the FDA Take a Peek? Part 2: Other Agencies

July 18, 2023

Enforcement

Expert Commentary | China Updates Clinical Trial Guidance on “Safety Information Assessment and Risk Management Work Procedures”

July 13, 2023

Enforcement

Expert Commentary | Updates to FDA’s Manual of Policies and Procedures (MAPP)

July 12, 2023

Conference Spotlight

A Deep Dive into Cell and Gene Therapy Regulatory Considerations: Part Two

May 25, 2023

Conference Spotlight

A Deep Dive into Cell and Gene Therapy Regulatory Considerations: Part One

April 27, 2023

Enforcement

Internal Audit Reports: Can the FDA Take a Peek?

April 19, 2023

Conference Spotlight

Should ICH Tackle Standard Development for CGT Products?

March 8, 2023

Conference Spotlight

FDA on the Evolution of Biologics Inspections: Part III

January 26, 2023

Conference Spotlight

FDA on the Evolution of Biologics Inspections: Part II

December 6, 2022

Conference Spotlight

FDA on the Evolution of Biologics Inspections: Part I

November 28, 2022

Conference Spotlight

The Evolving Clinical Trial Ecosystem

November 2, 2022

Conference Spotlight

Persistent Non-Compliance Leads to a Consent Decree

October 27, 2022