About this course
Whether you are working toward the registration of your first CE marked product or you are wanting to diversify into the medical device supply chain, ISO 13485 is the standard required for all regulatory aspects associated with your processes. This course takes you through how to plan and execute an implementation project enabling you to walk away understanding exactly what needs to be done and how to successfully implement ISO 13485 within your organisation.
NSF-DBA have quality management experts with experience of various notified bodies and industry best practices so that we can train and educate in the most effective methods to give you confidence of a successful implementation.
The course is unique in that we approach it from a project management perspective, understanding exactly how you work in the real world of industry. We steer away from just regurgitating the requirements and focus you specifically on what needs to be done, how it needs to be done and why so that you can plan with confidence, easily communicate the necessity for the variety of processes, procedures and systems necessary to demonstrate compliance and gain confidence of implementation.
The course is fast-paced, highly interactive and progressive, providing you with all of the necessary tools to begin your project.
Who should attend
Personnel responsible for implementing ISO 13485 and medical device GMP within their organisation.
Course outline
Without listing all of the processes required from ISO 13485, you will learn how to design the specific processes, ranging from how to implement a design control process through to how to plan the information and analysis of data necessary to review product performance and determine regulatory vigilance.
You will learn how to stay on top of the ever-changing requirements associated with standards, specification and regulatory requirements, therefore enabling your processes to be up-to-date and capable of giving you confidence that your organisation is effective.
You will be able to manage the implementation project, assigning tasks, milestones, activities, resources and outcomes necessary to be able to advise with confidence that anticipated costs, project management monitoring and communicate effectively with either your supply chain and/or your management team.
Venue
AMP Technology Centre, Sheffield, UK
We have selected the Advanced Manufacturing Park (AMP) Technology Centre near Sheffield as its location and environment are ideal to centralise and control our services. Based in a region well known for its expertise in healthcare manufacturing technologies and supported by clinical and academic excellence, the Centre provides an ideal location for business events, meetings, seminars, training events and small scale trade shows. With free parking, proximity to the M1 and M18, and within an hour’s drive of Leeds, Manchester, Sheffield, Bradford, Nottingham and Leicester, it is a convenient and accessible location.
The AMP has been designed to accommodate a range of manufacturing related activities, from the work of fledgling engineering and technology companies to the University of Sheffield’s collaboration with some of the world’s foremost advanced manufacturing technology businesses, such as Boeing and Rolls Royce.
Hotel Accommodation
We have a block booking of bedrooms at both the Aston Hotel Sheffield and the Holiday Inn Rotherham-Sheffield at a specially negotiated bed and breakfast rate. Hotel reservations should be made directly with the hotel. Please quote ‘NSF’ at the time of booking.
Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure that you are aware of the hotel’s cancellation policy.
Aston Hotel Sheffield, to book please call the hotel on +44 (0) 1142 615690, quoting ‘NSF’.
Holiday Inn Rotherham-Sheffield, to book please call the hotel on +44 (0) 1709 830630, quoting ‘NSF’.
Venue Address and Contact Details
AMP Technology Centre
Advanced Manufacturing Park
Brunel Way
Rotherham
S60 5WG
England
Tel: +44 (0)114 254 1200
Fax: +44 (0)114 254 1201
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