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Regular posts covering guidance changes, inspection findings, data methodology, and Redica product updates.

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Redica Systems
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Regular posts covering guidance changes, inspection findings, data methodology, and Redica product updates.
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Conference Spotlight

FDA on the Evolution of Biologics Inspections: Part II

December 6, 2022
Jerry Chapman
Biologics
CDER
FDA
FDA Inspections
GMP by the Sea
Conference Spotlight

FDA on the Evolution of Biologics Inspections: Part I

November 28, 2022
Jerry Chapman
Biologics
CBER
ConOps
FDA
FDA Inspections
Trends

Instant Download: Insights on Quality from FDA Leaders

November 8, 2022
Redica Systems
No items found.

Quality Week 2022: A Global Celebration of Quality

November 7, 2022
Rebecca Stauffer
Quality Week

On-Demand Webinar | Data Integrity and Quality Culture

November 3, 2022
Redica Systems
No items found.
Conference Spotlight

The Evolving Clinical Trial Ecosystem

November 2, 2022
Jerry Chapman
clinical trials
Donald Ashley
GCP
Conference Spotlight

Persistent Non-Compliance Leads to a Consent Decree

October 27, 2022
Jerry Chapman
CDER
Compliance
consent decree
Contamination
FDA
Conference Spotlight

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

October 26, 2022
Jerry Chapman
No items found.
Conference Spotlight

Senior Management Failures Lead to Patient Deaths, Prison Sentence

October 25, 2022
Jerry Chapman
CDER
Compliance
FDA
patient deaths
PharmaTech

Data Integrity Insights for Audit Planning

October 20, 2022
Rebecca Stauffer
Audit
audit planning
Data Integrity
equipment
laboratory
Conference Spotlight

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

October 19, 2022
Jerry Chapman
APAC
auditing
GMP
inspection preparation
Japan

On-Demand Webinar | The Insider’s Guide to FDA Audit Readiness

October 18, 2022
Redica Systems
No items found.

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

October 14, 2022
Redica Systems
No items found.
Conference Spotlight

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

October 11, 2022
Jerry Chapman
101
APAC
Asia-Pacific
Drug Approval
Pharma

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

October 6, 2022
Jerry Chapman
101
CDER
CVM
FDA
GMP
Conference Spotlight

How To Get Drug Products Approved In Asia-Pacific Markets

October 5, 2022
Jerry Chapman
101
APAC
Pharma

On-Demand Webinar | Top 10 Regulatory Surveillance Signals

October 4, 2022
Redica Systems
No items found.
Conference Spotlight

Who Decides if my FDA Inspection is Classified OAI?

September 29, 2022
Jerry Chapman
483
CFR
Code of Federal Regulations
compliance officer
FDA

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