An FDA warning letter over quality system deficiencies can stall a medical device company in its tracks — which is exactly why understanding the Quality System Regulation (QSR) properly, rather than reading it after the fact, matters so much. The QSR sets out the requirements the FDA expects from manufacturers of medical devices sold in the United States, and getting it wrong tends to show up fast, in inspections and in correspondence nobody wants to receive.

This course from the Arab British Fellowship Training Academy walks participants through what the QSR actually requires, how it connects to broader industry standards and guidance documents, and how to read FDA warning letters and recognise the situations that trigger them — building the kind of audit evidence that supports real compliance rather than paperwork for its own sake.

Knowledge and Benefits

By the end of this course, participants will be able to:

• Analyse the meaning of the QSR's elements, and understand the purpose, benefits and objectives behind FDA's Medical Device Quality System Regulation.
• Compare how standards and guidance documents relate to and support FDA compliance initiatives.
• Read FDA warning letters and recognise the situations that typically trigger a warning over QSR deficiencies.
• Map the requirements of the QSR and build the audit evidence needed to support FDA compliance.

Who Should Attend?

• R&D managers, engineering managers and management representatives who need to understand and apply QSR requirements.
• Product, project and program managers, along with RA/QA managers and engineers.
• Internal auditors and other cross-functional team members involved in quality and regulatory work.

Module 1: Learning From the Field — Recent FDA Inspection Findings

• Recent FDA inspectional observations and what they reveal about common gaps.

Module 2: Where QSR Fits Within Medical Device Regulation

• Introduction to Medical Device Regulation (MDR).
• The Quality System Regulation (QSR) as an integral part of the management system.

Module 3: Inside the QSR — Background and Subpart-by-Subpart Review

• QSR background.
• QSR subpart reviews.