Conference Spotlight Posts

Conference Spotlight

Drug GMP Warning Letter Issued Without Facility Inspection

Jerry Chapman
Conference Spotlight

Looking Outside Your Four Walls at GMP by the Sea

Redica Systems
Conference Spotlight

FDA Post-Warning Letter Meetings are Not Agency Consultations

Jerry Chapman
Blog

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

Jerry Chapman
Blog

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

Jerry Chapman
Blog

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

Jerry Chapman
Blog

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

Jerry Chapman
Blog

Is Raw FDA Data Skewing Your Analyses?

Redica Systems
Blog

Should ICH Tackle Standard Development for CGT Products?

Jerry Chapman
Blog

FDA on the Evolution of Biologics Inspections: Part III

Jerry Chapman
Blog

How “Inevitable” Data Integrity Issues Cause Havoc: Part II

Redica Systems
Blog

FDA on the Evolution of Biologics Inspections: Part II

Jerry Chapman
Blog

FDA on the Evolution of Biologics Inspections: Part I

Jerry Chapman
Blog

The Evolving Clinical Trial Ecosystem

Jerry Chapman
Blog

Persistent Non-Compliance Leads to a Consent Decree

Jerry Chapman
Blog

Japan’s PMDA Formalizing Post-Approval Change System Based on Recent Pilot

Jerry Chapman
Conference Spotlight

Senior Management Failures Lead to Patient Deaths, Prison Sentence

Jerry Chapman
Blog

Post-Approval Change Management Protocol Pilot Aims to Reduce Approval Time

Jerry Chapman
Blog

How “Inevitable” Data Integrity Issues Cause Havoc: Part I

Redica Systems
Conference Spotlight

Navigating Drug Approvals and Post-Approval Changes in the Asia-Pacific Region

Jerry Chapman
Blog

Why am I Being Inspected Again So Soon After a Pre-Approval Inspection?

Jerry Chapman
Conference Spotlight

How To Get Drug Products Approved In Asia-Pacific Markets

Jerry Chapman
Blog

Who Decides if my FDA Inspection is Classified OAI?

Jerry Chapman
Conference Spotlight

Getting Drugs Approved in Mexico, Argentina, Colombia, And Peru

Jerry Chapman
Blog

How to Get New Drugs Approved in Brazil

Jerry Chapman
Blog

Where is My EIR?

Jerry Chapman
Blog

FDA on Compliance Issues in Pharma

Jerry Chapman
Blog

CMC Challenges and Opportunities in Latin America

Jerry Chapman
Blog

An FDA Perspective on Decentralized Clinical Trials: Part III

Jerry Chapman
Blog

An FDA Perspective on Decentralized Clinical Trials: Part II

Jerry Chapman
Blog

An FDA Perspective on Decentralized Clinical Trials: Part I

Jerry Chapman
Blog

From Data Integrity to Data Culture

Rebecca Stauffer
Blog

Five FDA Warning Letters Issued in Four Years for Fraudulent Cancer Drug

Jerry Chapman
Blog

Extracting Specific Protocol Violations from Warning Letter Citations

Redica Systems Staff and Jerry Chapman
Blog

FDA Issues First Notices of Noncompliance on ClinicalTrials.Gov

Jerry Chapman
Blog

The Components of “Responsibilities of the Investigator” Observations

Redica Systems Staff and Jerry Chapman
Blog

Perforated Tables in Cleanrooms Draw FDA Attention

Jerry Chapman
Blog

Data Integrity and Your Clinical Investigator: What the Data Shows

Redica Systems Staff and Jerry Chapman
Blog

Discolored HEPA Filters Recolored by Sterile Manufacturer

Jerry Chapman
Blog

Inadequate Equipment Cleaning Leads to Cross Contamination, FDA Warnings

Jerry Chapman
Blog

Change Management Failures Documented in FDA Warning Letter

Jerry Chapman
Blog

Ensure Adequate Investigations at Your CMO With a QRM Mindset

Rebecca Stauffer
Blog

Is Your Quality System Up to Par for Your Next FDA Inspection?

Rebecca Stauffer
Blog

How One Pharma Firm Ensures Robust GMP CAPA Effectiveness at CMOs

Rebecca Stauffer
Blog

UDI Compliance for Medical Devices: Part II

Mark Agostino
Blog

ICH Q9: Quality Risk Management Revision Focuses on Six Topic Areas

Rebecca Stauffer
Blog

What is the Best Way to Prepare for an FDA inspection?

Rebecca Stauffer
Blog

UDI Compliance for Medical Devices: Part I

Mark Agostino