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

Redica Responds: Clinical Investigators and Paper Record Controls

August 10, 2022
Redica Systems
clinical investigator
Data Integrity
GCP
gcp inspections
Redica Responds

What Are Medical Device Design Controls? A Complete 2025 Guide

August 9, 2022
Redica Systems
BIMO
Combination Products
design controls
Devies
FDA
Conference Spotlight

An FDA Perspective on Decentralized Clinical Trials: Part II

August 4, 2022
Jerry Chapman
ALCOA
Anne Johnson
Data Integrity
DCT
decentralized clinical trials

Redica Responds: Cleaning Validation 483 Observations

August 3, 2022
Redica Systems
483
cleaning
cleaning validation
Redica
Redica Responds

What to Look for in a CMO

August 2, 2022
Rebecca Stauffer
101
CMO
contract manufacturing
contract manufacturing organization
risk management
Conference Spotlight

An FDA Perspective on Decentralized Clinical Trials: Part I

July 28, 2022
Jerry Chapman
Anne Johnson
BIMO
clinical trials
DCT
decentralized clinical trials

Redica Responds: Repeat Observations by Region

July 27, 2022
Redica Systems
483
483 observations
FDA
Redica
repeat observations

Human Factors and Usability for Medtech Products

July 26, 2022
Rebecca Stauffer
101
Alison Sathe
Combination Products
Devices
FDA

On-Demand Webinar | A Fresh Take on Pre-Approval Inspection Data

July 25, 2022
Redica Systems
Michael de la Torre
PAI
pre-approval inspections
Redica
Small Pharma
Conference Spotlight

From Data Integrity to Data Culture

July 21, 2022
Rebecca Stauffer
2022 PDA Annual Meeting
clinical research organization
CROs
data culture
Data Ingegrity

Redica Responds: How Many Change Control 483s Over the Last Ten Years?

July 20, 2022
Redica Systems
483
change control
change management
FDA
Redica

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