CPDEquivalent to 7 hours
CERTIFICATESAll delegates will receive a certificate on completion.
Quality System Regulations (QSR) for Medical Devices CGMP 21 CFR Part 820
This practical 1-day course examines the demands of the FDA’s Quality System Regulations (QSR) and related product safety requirements with a view to the design and delivery of compliant products.
Interactive workshops and discussions will allow your team to consider together how they may successfully implement methods and ideas learned on this course.
- executives and senior management
- R&D managers/engineers and members of design review teams
- RA/QA managers and management representatives
- members of multi-discipline design teams
- sales and marketing, production, shipping, MIS, purchasing
- FDA requirements and how they might affect an organisation
- implementing the requirements effectively so as not to affect other regulatory requirements
- locating key pieces of information within the appropriate documents (DHF, DMR and DHR)
- review of related standards such as risk analysis and the applicable guidance documents
- the relationship between QSR and the Medical Devices Directive/In Vitro Diagnostic Medical Devices (MDD/IVDD) and ISO13485/ISO9001 standards requirements
- regulatory requirements for reporting incident/near incidents (MDR)
- addressing 21 CFR Part 11 Electronic Signature and Records
- adding value to an organisation’s management system
- preparing for an FDA Quality System Inspection Technique (QSIT) type audit
- sources of information and further development
- interpret the requirements of QSR and its relationship with MDD/IVDD and ISO 13485/ISO 9001 requirements
- identify the methods for successful implementation of the regulations
- prepare for an FDA QSIT-type audit and add value to an organisation’s management system
Quality System Regulation is a system to ensure that products are safe, and is applied to FDA-regulated products, including medical devices, in the US. The requirements apply to manufacturers of medical devices who plan to bring products to market.
If you are planning to market medical devices, you will need to ensure they comply with the Food and Drug Administration’s stringent requirements. The tutor will spend the day explaining Quality System Regulations (QSR) for Medical Devices CGMP 21 CFR Part 820 and how its requirements might interact with other standards being applied in your organisation. The tutor will point you to salient points within the regulation and other valuable resources, and explore preparation for an audit.
If you wish to market a device in the EU, you may like to take a look at our 1-day course on
Understanding the European Directive 93/42/EEC concerning Medical Devices.
Bywater runs a comprehensive programme of training around the requirements placed on medical device developers and manufacturers to ensure devices meet standards on safety and usability. These include introductory and more detailed training around auditing, risk analysis, and regional requirements. Our complementary courses focus on a number of standards relevant to medical devices, such as ISO 13485, ISO 14971, Quality Systems Regulations, and BS EN 62366.
We deliver the 1-day Quality System Regulations for Medical Devices training course as a dedicated course for your organisation. This gives you the opportunity to determine where you would like the course to run – at your offices, at another venue, or online. You can also choose a date that is most convenient for you.
Peel Ports Group|13th Nov, 2023
Sense Biodetection Ltd|8th Nov, 2023
Tata Steel UK Ltd|27th Oct, 2023
Orthoplastics Ltd|27th Oct, 2023
Expro North Sea Limited|24th Oct, 2023
Port Of Antwerp-Bruges International|19th Oct, 2023
Swann-Morton Ltd|13th Oct, 2023
Trant Engineering Ltd|6th Oct, 2023
Mott MacDonald Ltd|29th Sep, 2023
Premier Partnership|11th Sep, 2023
Ubitricity Distributed Energy Systems UK Ltd|30th Aug, 2023
Huntleigh Healthcare|8th Aug, 2023