About this course
The analysis of data is critical to the decisions and actions taken by a medical device organisation, whether it is a decision to recall a product because of a trend in complaints or a decision to initiate a process change due to a statistical skew in manufacturing quality data. What is evident is a very clear ‘trend’ by regulatory agencies to challenge your decisions, particularly those which are statistically based.
The course aims to discuss the application of statistics, the recent trends and challenges by regulatory agencies and how to approach your data so that you are confident that you have established the right information using the right tools, and come to the right conclusion!
Who should attend
Anyone who uses or plans to use statistics in their decision making processes. Within the devices industry this is generally…
- Quality Managers
- Development Engineers
- Clinical Investigators and people performing meta analysis
- Manufacturing and Quality Engineers
- Regulatory Auditors
Course outline
The correct application of statistical tools: how to ensure that the data is appropriate and can actually be analysed using the right tools and interpreted using the right calculations and statistical models.
You will be able to answer questions such as:
- Why did you validate using the sample size of parts?
- Why is the analysis of your complaints data a trend or not a trend?
- Goods inwards verification sampling strategy – what is the reason for it?
- Why was the data from the clinical investigation statistically significant?
- Why did you use CpK and not PpK?
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
An NSF International Company
