GMP and Medical Device Training Courses: US FDA and EU GMP, Online

FDA's rule for electronic records and electronic signatures: when they can stand in for paper and handwritten signatures, with audit trails, access controls and validated systems.

Part 11 applies whenever a record that another FDA rule requires is kept electronically, or signed electronically. Investigators ask for the audit trail of a result, check that each user has a unique login, look for shared accounts and test whether a changed value can be traced to who changed it, when and why. Start with Data Integrity (ALCOA+) and 21 CFR Part 11 for everyone who creates or reviews GxP data; add Computer System Validation (GAMP 5) for system owners, IT and validation staff.

The US current good manufacturing practice rules for finished pharmaceuticals, covering personnel, buildings, equipment, components, production, laboratory controls, records, returns and complaints.

Section 211.25 requires every person in manufacturing, processing, packing or holding to have the education, training and experience for the job, with training in CGMP given by qualified people and repeated often enough to stay current. Investigators compare training records against job descriptions and the SOPs each person signs. Start with GMP Awareness or US FDA CGMP Implementation for the site, then add the role course for each team: operators, documentation, deviations, change control, warehouse, sampling and aseptic work.

The Quality Management System Regulation for medical devices, which incorporates ISO 13485 by reference and adds FDA's own requirements.

The Quality Management System Regulation took effect on 2 February 2026 and incorporates ISO 13485:2016 by reference, so competence, training and records of training now follow the standard's requirements, with FDA's own additions. Device makers selling in the US need staff who understand both. Start with US FDA QMSR (21 CFR Part 820) for quality and regulatory staff, Design Controls for R&D, and the ISO 13485 implementation or internal auditor course for the people who run and check the system.

FDA's Good Laboratory Practice rules for nonclinical laboratory studies that support applications, from the study director to the quality assurance unit.

The GLP rule requires that study personnel have the education, training and experience for their functions, that the facility keeps a current summary of each person's training and a job description, and that an independent quality assurance unit inspects each study. FDA's GLP inspections test exactly those records. Start with Good Laboratory Practice (US FDA 21 CFR Part 58) for study directors, laboratory staff, archivists and QA unit members.

FDA's recall policy and classification, with the drug CGMP rule on complaint files, investigation and follow-up.

FDA classifies recalls by health hazard as Class I, II or III, and expects a firm to handle a complaint file under written procedures, review each complaint, decide whether to investigate and record why. A weak complaint system is one of the most common reasons a recall arrives late. Start with Drug Complaints and Recalls Training (US FDA) for QA, complaint handlers, distribution and regulatory staff.

The US rules for reporting adverse drug experiences after approval, including expedited and periodic reports.

After approval, applicants must report serious and unexpected adverse drug experiences to FDA within 15 calendar days, and submit periodic reports quarterly for the first three years and annually after that. Late or incomplete reports are a frequent inspection finding for safety and medical affairs teams. Start with Postmarketing Drug Safety Reporting Training (US FDA) for pharmacovigilance, medical information and the staff who receive safety information.

The EU GMP Guide: Part I for medicinal products and Part II for active substances, with the procedures behind inspections, complaints and recalls.

Chapter 2 of the EU GMP Guide expects initial and continuing training for every person whose duties take them into production, storage or control areas, including technical, maintenance and cleaning staff, and that the practical effectiveness of training is assessed. Part II applies the same expectations to active substance makers. Start with EU GMP Essentials for the site, API GMP Training (ICH Q7) for active substance plants, and the inspection and recall courses for QA.

The annexes that add specific expectations: sterile manufacturing, biological products, herbal products, qualification and validation, and batch certification by the Qualified Person.

The annexes add specific expectations on top of the GMP Guide. Annex 1, revised with effect from 25 August 2023, requires a contamination control strategy and specific training for everyone in clean areas. Annex 15 sets out qualification and validation, and Annex 16 defines how the Qualified Person certifies a batch. Choose the course for the annex that applies to your products, and pair Annex 15 with Cleaning Validation for validation teams.

The EU Medical Device Regulation: classification, conformity assessment, the duties of manufacturers, importers and distributors, and post-market obligations.

The EU MDR has applied since 26 May 2021. It places obligations on manufacturers, authorised representatives, importers and distributors, and requires a person responsible for regulatory compliance. Notified bodies check that staff understand classification, technical documentation, post-market surveillance and vigilance. Start with EU MDR Awareness for quality, regulatory, R&D and commercial staff, then the device courses for the roles that own each process.

The EU legal framework and Good Pharmacovigilance Practices for safety reporting, signal management, risk management plans and the pharmacovigilance system.

EU marketing authorisation holders must run a pharmacovigilance system described in a master file, with a qualified person for pharmacovigilance and the processes set out in the Good Pharmacovigilance Practices modules. Inspectors check that everyone who could receive safety information knows how to report it. Start with Pharmacovigilance Training (EU GVP) for safety teams, medical information, sales and the qualified person's deputies.

International guidelines adopted by regulators: GMP for active substances, quality risk management and good clinical practice.

ICH guidelines set the common expectations adopted by regulators in the US, EU, Japan and other member regions. Q7 is GMP for active substances, Q9(R1) is quality risk management, revised in 2023, and E6(R3), finalised by ICH in January 2025, is the current good clinical practice guideline. Start with ICH Q9 Quality Risk Management for QA and process owners, and the GCP course for clinical and investigational product staff.

The international principles of good laboratory practice used for non-clinical safety studies, with the consensus and advisory documents that explain them.

The OECD Principles of GLP underpin the mutual acceptance of non-clinical safety data between OECD member countries. They require test facility management to ensure qualified, trained personnel, a study director for each study and an independent quality assurance programme. Start with Good Laboratory Practice Training (OECD) for laboratories outside the US, or for studies submitted in several regions.

The quality management, risk management and software life cycle standards behind device regulation, and the single audit program accepted by five regulators.

ISO 13485:2016 is the quality management standard for medical devices, ISO 14971:2019 sets out risk management across the device life cycle, IEC 62304 covers software life cycle processes, and MDSAP lets one audit serve the regulators of Australia, Brazil, Canada, Japan and the United States. Start with ISO 13485 Awareness for all staff, ISO 14971 for risk owners, IEC 62304 for software teams and MDSAP for quality managers preparing for the audit.