Process Capability in Focus in FDA Device Inspections

Process capability—the measure of how well a manufacturing process consistently produces products that

Many Device Cleaning Validation Programs Need Work, FDA Investigator Says

Common issues found during agency inspection of cleaning programs and cleaning validation at medical device

Navigating a Regulatory Path to Market Through EU MDR Article 117

The regulatory framework outlined in EU Medical Device Regulation (MDR) Article 117 to bring drug-device

FDA Issues 38-Page 483 to Solid Oral Dosage Manufacturer

FDA recently posted a 38-page form 483 issued to Novel Laboratories, Inc d.b.a.

OTC Skincare Firm Receives Warning Letter Due to CGMP Concerns

December is generally a slow time when it comes to posting of FDA Warning Letters. Nevertheless, on Dec.

FDA Warning Letters: 11/22/2020 & 12/1/2020

The week of the U.S. Thanksgiving holiday was yet again another week that was light on Warning Letter

How Small Pharma Firms Can Prepare for a GMP Inspection

[Editor's Note: This post has been updated; originally published on June 13, 2019.] Preparing for GMP

Part II: An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

[Editor's Note: This is Part II of an analysis of the FY2019 UK MHRA GMP deficiencies by Redica Systems

Part I: An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

[Editor's Note: Below is Part I of an analysis of the U.K. MHRA GMP deficiencies for 2019. Part II will

Webinar – A.I. for Quality and Compliance Teams

Webinar – Human Factors – Compliance and Applications

Webinar – Panel Discussion Remote Audits

Report – 2019 Human Tissue and Cell Therapy Observations

Report – CDMO Comparison Report

Report – 5 GMP Case Studies

Assessment – Investigator Snapshot

Assessment – Peer Benchmark Report

Assessment – CFR Trend Report