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

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Alison Sathe
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Redica Systems
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Scott Sherrill
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Regular posts covering guidance changes, inspection findings, data methodology, and Redica product updates.
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Understanding MHRA UK Compliance in Pharma and MedTech

December 4, 2024
Redica Systems
No items found.

FDA Inspection Database: An Essential Tool to Prepare for FDA Inspections

November 29, 2024
Redica Systems
FDA
FDA Database
Enforcement

Granules India FDA 483 Includes Potential Contamination and Data Integrity Findings

November 26, 2024
Jerry Chapman
483
483 Findings
Data Integrity
Form 483
Granules India
Trends

MedTech 2024 Highlights: A Look at iCGM Systems and CPAP Machines

November 25, 2024
Jerry Chapman
2024 highlights
CPAP Machines
FDA
iCGM
iCGM Systems
Trends

Using CGMP Site Risk Scores to Predict Drug Shortages

November 22, 2024
Katie Terry
CGMP
Drug Shortages
FDA
Predict Drug Shortages
Redica Systems

Addressing FDA’s Biggest Challenges

November 15, 2024
Scott Sherrill
China
Drug Shortages
FDA
FOIA
import alert

Tianish Laboratories Private Limited: A Timeline of Regulatory Assessments

November 13, 2024
Redica Systems
No items found.
Conference Spotlight

Facility Issues Top Inspection Deficiencies for Biologics

November 12, 2024
Jerry Chapman
BLAs
CDER
OPMA
OPQ
PDA/FDA
Trends

How Much Can Poor Quality Cost You?

November 8, 2024
Redica Systems
483
483 observation
483 response
Cost of Quality
Quality
Enforcement

Navigating FDA Guidelines for Combination Products: A Comprehensive Guide

November 6, 2024
Redica Systems
Combination Products
FDA Database
FDA Approval
Guidelines
medical devices

KVK-Tech Warning Letters: A Timeline of Regulatory Assessments

October 30, 2024
Redica Systems
No items found.
Enforcement

ICH Q9 Quality Risk Management in Pharma

October 15, 2024
Redica Systems
ICH
ICH Q9
Pharma
QRM
Quality Risk Management
Enforcement

FDA Inspection Shows Systemic Data Falsification Issues

October 11, 2024
Jerry Chapman
483
API
API Manufacturer
Data Falsification
Conference Spotlight

Who is Responsible When GMPs Are Not Followed?

October 9, 2024
Jerry Chapman
CDER
CDER Updates
CDMO
CMO
Contract Facilities
Enforcement

Comprehensive Guide to 21 CFR 820.30 for MedTech

October 8, 2024
Redica Systems
483 observations
ALCOA
consent decree
EMA
FDA
Conference Spotlight

What is a VAI or OAI Regulatory Meeting?

October 2, 2024
Jerry Chapman
CDER
CGMP
DOJ
FDA
Guidance

Introducing PostMarket Intelligence for MedTech Companies

September 30, 2024
Redica Systems
adverst event
LMS
Medtech
Postmarket Intelligence
postmarket surveillance
Conference Spotlight

FDA Investigator Attrition Rate Addressed at 2024 PDA/FDA Conference

September 11, 2024
Jerry Chapman
FDA

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