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

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

Should ICH Tackle Standard Development for CGT Products?

March 8, 2023
Jerry Chapman
483
GMP
ICH
ISPE Annual Meeting
Pharma

What Are Inferred CFR Codes?

February 24, 2023
Redica Systems
CFR
citations
Dupont
FDA
Form 483

On-Demand Webinar | Comparing Inspection Observations between FDA and Health Canada

February 9, 2023
Redica Systems
No items found.

Does Your Lab Instrumentation Adhere to Data Integrity Requirements?

February 2, 2023
Rebecca Stauffer
analytical instruments
Bob McDowall
Data Ingegrity
Quality
Conference Spotlight

FDA on the Evolution of Biologics Inspections: Part III

January 26, 2023
Jerry Chapman
Biologics
BLAs
FDA
FDA inspection
remote inspection

The “O” in ALCOA

January 17, 2023
Redica Systems
No items found.

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

December 12, 2022
Redica Systems
No items found.
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

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