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

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Alison Sathe
Anders Vinther
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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

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

September 27, 2022
Jerry Chapman
101
ANMAT
Argentina
COFEPRIS
Colombia

Good Quality, Poor Quality in the Pharmaceutical Industry

September 22, 2022
Anders Vinther
blame culture
contract manufacturing
guest article
Pharma
Quality
Conference Spotlight

How to Get New Drugs Approved in Brazil

September 21, 2022
Jerry Chapman
ICH
Latin America
Pharma

Where is My EIR?

September 20, 2022
Jerry Chapman
EIR
FDA
FDA inspection
Francis Godwin
NAI
Conference Spotlight

FDA on Compliance Issues in Pharma

September 16, 2022
Jerry Chapman
Donald Ashley
FDA
FDA inspection
Francis Godwin
GMP

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

September 14, 2022
Redica Systems
483
FDA inspection
GMP
Pharma
Redica
Conference Spotlight

CMC Challenges and Opportunities in Latin America

September 13, 2022
Jerry Chapman
CMC
Drug Approval
Latin America
Pharma
Trends

PAIs and 483 Issuance Risk: The Trends Are Not What They Seem

September 8, 2022
Redica Systems
483
deviations
Enforcement Analytics
FDA
pre-approval inspections

Redica Responds: Do You Know Where Your Quality Unit Is?

September 7, 2022
Redica Systems
483
483 observations
quality unit

ALCOA Data-Integrity Principles: A Complete 2025 Guide

September 6, 2022
Redica Systems
483 observations
ALCOA
ALCOA-C,
consent decree
EMA

Redica Responds: Top Quality Systems Issues at Medical Device Sites

August 31, 2022
Redica Systems
Devices
FDA inspection
quality system
Redica Responds

Regulatory Expectations for Cleaning Validation

August 30, 2022
Rebecca Stauffer
101
cleaning
cleaning validation
Contamination
Devices

Redica Responds: Insights on Media Fill Enforcement Trends

August 24, 2022
Redica Systems
483
aseptic processing
GMP
Pharma
Redica

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

August 23, 2022
Rebecca Stauffer
Audit
FDA
Pharma
Remote Audits

Instant Download | Particle Contamination Risks of Cloth Wipes

August 18, 2022
Redica Systems
No items found.

Redica Responds: Deviation Investigation 483 Trends

August 17, 2022
Redica Systems
483
deviation investigations
deviations
inadequate deviation investigations
Redica

GMP Considerations for Cell and Gene Therapies

August 16, 2022
Rebecca Stauffer
Cell and Gene
CGT
Data Integrity
FDA
GMP
Conference Spotlight

An FDA Perspective on Decentralized Clinical Trials: Part III

August 11, 2022
Jerry Chapman
clinical trials
FDA

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