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Regular posts covering guidance changes, inspection findings, data methodology, and Redica product updates.
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A Short Guide to GMP Process Validation

July 19, 2022
Rebecca Stauffer
101
2011 process validation guidance
CMO
contract manufacturing organization
FDA
Conference Spotlight

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

July 14, 2022
Jerry Chapman
BIMO
CDER
clinical hold
clinical trial monitor
clinical trial sponsor

Redica Responds: Contamination Control 483s

July 13, 2022
Redica Systems
483
Contamination
contamination control
cross-contamination
Redica

Medical Device UDI Requirements: What You Need to Know

July 13, 2022
Rebecca Stauffer
101
483
Devices
FDA
medical device supply chain

Invest in Tech to Avoid Data Integrity Issues

July 7, 2022
Rebecca Stauffer
Data Integrity
data integrity in the lab
GMP
pharma quality
Redica

Redica Responds: How Can I Compare Enforcement Histories for CMO Sites?

July 6, 2022
Redica Systems
CMO
contract manufacturing organization
contract operations
Redica Responds
Redica Systems

What Can Trigger a CAPA?

July 5, 2022
Rebecca Stauffer
101
CAPA
Devices
FDA
FDA inspection

Data Integrity and Your Analytical Instruments

June 30, 2022
Rebecca Stauffer
analytical instruments
Data Integrity
PIC/S data integrity guidance
Webinar

How Do I Build Quality Culture in My Organization?

June 29, 2022
Rebecca Stauffer
101
Data Integrity
FDA
Quality
quality culture

Redica Responds: What are the Top 483 Observations Involving Medical Device Postmarket Reporting?

June 28, 2022
Redica Systems
EU MDR
Redica Responds
Conference Spotlight

Extracting Specific Protocol Violations from Warning Letter Citations

June 23, 2022
Jerry Chapman
No items found.

What is GMP Compliance? A Complete 2025 Guide

June 21, 2022
Rebecca Stauffer
Compliance
FDA
FDA inspection
GMP
ISPE Annual Meeting
Conference Spotlight

FDA Issues First Notices of Noncompliance on ClinicalTrials.Gov

June 16, 2022
Jerry Chapman
clinical trial sponsor
clinical trials
GCP
NIH
RA-Clinical
Conference Spotlight

Instant Download | 4 GMP Case Studies

June 15, 2022
Redica Systems
No items found.

GMP Compliance: What is a GMP Quality Agreement?

June 14, 2022
Rebecca Stauffer
No items found.
Conference Spotlight

The Components of “Responsibilities of the Investigator” Observations

June 9, 2022
Jerry Chapman
483
clinical investigator
GCP
Jerry Chapman
SQA

Root Cause Analysis of Medical Devices

June 8, 2022
Rebecca Stauffer
CAPA
deviations
FDA
GMP
investigations

On-Demand Webinar | FDA GCP Inspection Trends Identified Using AI

June 7, 2022
Redica Systems
No items found.

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