Trench work kills people. Not as a rare or unpredictable occurrence, but regularly, and in ways that are almost entirely preventable. In the first half of 2022 alone, 22 US workers died in trench-related incidents, surpassing the total for all of
FDA Inspections Practice Test: 15 Data Integrity Qs
In every FDA inspection, whether GCP, GMP, or GLP, the fundamental question is the same: can the organisation prove that what it says happened actually happened, in the way it says it happened, when it says it happened? That question is answered t
European Vigilance for Medical Devices: Full Guide
Vigilance is the cornerstone of post-market safety oversight for medical devices in the European Union. Under Medical Device Regulation (MDR) No. 2017/745 and In Vitro Diagnostic Regulation (IVDR) No. 2017/746, manufacturers are legally required t
EU Clinical Trial Regulation CTR 536/2014 Guide
On 31 January 2022, Regulation (EU) No 536/2014 (the Clinical Trials Regulation, CTR) became applicable across the European Union, replacing the Clinical Trials Directive 2001/20/EC. The CTR applies to all clinical trials on medicinal products for
IVDR Compliance: A Regulatory Affairs Scenario
A regulatory affairs manager at a mid-sized in vitro diagnostics manufacturer is three weeks out from submitting a dossier to a notified body for CE marking under IVDR. During a final internal review, she notices that the device's IVDR classificat
EU Directives & Inspection Readiness: Complete Guide
Inspection readiness is not something an organisation builds in the weeks before a regulator arrives. It is the condition the organisation is in every other day of the year. For companies operating in or supplying to the EU market, that condition
Ethical Review Boards: 15 IRB Practice Questions
Institutional Review Boards (IRBs), also known as Ethical Review Boards or Independent Ethics Committees (IECs) outside the United States, exist to protect the rights, safety, and welfare of people who take part in research. Before any clinical tr
How FDA Inspections Enforce Postmarketing Adverse Drug Experience Reporting
A practical guide to understanding how FDA inspections enforce postmarketing reporting rules and protect public health. Table of Contents Introduction Understanding Postmarketing Adverse Drug Experience Reporting FDA’s Autho
Safe Handling Practices During Product Destruction in Regulated Industries (USA)
In regulated industries, like pharmaceuticals, biotech, chemicals, and food, product destruction is a serious task. Whether the product is expired, recalled, contaminated, or simply unsellable, it must be destroyed properly. This keeps workers safe,