Articles tagged with “fda-inspection”

FDA QMSR: Internal Audit Reports No Longer Confidential

Learn how FDA QMSR impacts 21 CFR 820. Internal audit and management review records are no longer confidential and subject to inspection under the new rule.

20 min read

2/27/2026

fda qmsr iso 13485 internal audits 21 cfr part 820 medical device regulations fda inspection management review quality management system

FDA QMSR & ISO 13485: New Inspection Playbook Guide

Analyze the FDA QMSR final rule, ISO 13485 alignment, and the new CP 7382.850 inspection playbook. Learn key compliance steps for device manufacturers.

35 min read

2/27/2026

fda qmsr iso 13485 medical device regulation 21 cfr part 820 quality management system fda inspection risk management cp 7382.850 regulatory affairs medtech

FDA QMSR & ISO 13485: Key Changes Effective 2026

Analyze the FDA Quality Management System Regulation (QMSR) effective Feb 2, 2026. Learn how ISO 13485:2016 incorporation impacts medical device compliance.

50 min read

2/27/2026

fda qmsr iso 13485 medical device regulation 21 cfr part 820 quality management regulatory compliance fda inspection device manufacturers

FDA Interview Discipline: Preventing Skill Decay with AI

Explore the role of interview discipline in FDA inspections. This analysis covers skill decay causes and how AI tools augment auditor questioning techniques.

45 min read

2/25/2026

fda inspection interview discipline audit questioning skill decay ai compliance regulatory affairs quality assurance nlp tools auditor training

FDA Inspection Readiness: A Guide for Clinical Sites & CROs

Prepare for FDA BIMO inspections with this updated 2026 guide for clinical sites & CROs. Covers ICH E6(R3), finalized BIMO guidance, RRAs, documentation, QMS, staff training, & GCP compliance.

30 min read

11/19/2025

fda inspection inspection readiness bimo good clinical practice (gcp)clinical trial audit cro quality management system form 483

FDA Pre-License Inspection (PLI): A Guide for Biologics

Explore the FDA Pre-license Inspection (PLI) process for biologics. This guide explains the PLI's purpose, scope, cGMP requirements for BLA approval, and the latest 2025-2026 developments including AI-driven inspection targeting, remote assessments, and the BIOSECURE Act.

30 min read

11/16/2025

pre-license inspection fda inspection biologics license application cgmp regulatory compliance biomanufacturing pli vs pai

FDA 483 Response: A Guide to Best Practices & Compliance

Learn best practices for writing an effective FDA 483 response. Updated with FY2024-2025 enforcement data and FDA's AI-driven inspection targeting. Covers CAPAs, timelines, and strategies to avoid Warning Letters.

40 min read

10/12/2025

fda 483 response fda warning letter capa regulatory compliance fda inspection cgmp inspectional observations