Pharma

Enforcement

ICH Q9 Quality Risk Management in Pharma

October 15, 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

Audience Q&A: From Legal Considerations when Interacting with the FDA Webinar

August 10, 2023

Enforcement

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

July 18, 2023

Enforcement

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

July 12, 2023

Peter Baker’s Roadmap to Quality Intelligence

June 1, 2023

Conference Spotlight

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

May 25, 2023

Enforcement

Internal Audit Reports: Can the FDA Take a Peek?

April 19, 2023

Conference Spotlight

Is Raw FDA Data Skewing Your Analyses?

March 23, 2023

Conference Spotlight

Should ICH Tackle Standard Development for CGT Products?

March 8, 2023

Conference Spotlight

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

October 19, 2022

Conference Spotlight

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

October 11, 2022

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

October 6, 2022

Conference Spotlight

How To Get Drug Products Approved In Asia-Pacific Markets

October 5, 2022

Conference Spotlight

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

September 27, 2022

Good Quality, Poor Quality in the Pharmaceutical Industry

September 22, 2022

Conference Spotlight

How to Get New Drugs Approved in Brazil

September 21, 2022

Redica Responds: How Many GMP Inspections Have Resulted in a 483?

September 14, 2022

Conference Spotlight

CMC Challenges and Opportunities in Latin America

September 13, 2022

Regulatory Expectations for Cleaning Validation

August 30, 2022

Redica Responds: Insights on Media Fill Enforcement Trends

August 24, 2022

GMP Audits: What Are They and Why Are They Important?

August 23, 2022

A Short Guide to GMP Process Validation

July 19, 2022

What Can Trigger a CAPA?

July 5, 2022

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