Analysing and Trending Data to Drive Quality Improvement

About this course

The pharmaceutical industry has historically under-utilised statistical data analysis techniques that have been used extensively in many other industries to drive product and process improvement. It is still too often true to characterise the pharmaceutical industry as being data rich but information poor.

Recent developments in the GMP Guidelines that provide regulatory expectations around the globe are now seeking to drive pharmaceuticals to catch up with other industries by placing far greater emphasis on the trending of data; eg EU GMP requirements for Product Quality Reviews, ICH Q10 and the US Guidance on Process Validation.

Performing statistical calculations is now relatively simple with a variety of software packages being available to do the ‘number crunching’. However, it is essential that the underpinning assumptions for the statistical techniques are understood and complied with. In order to obtain maximum benefit from the use of these sophisticated statistical software tools it is also vital that the outputs are correctly interpreted.

This course will provide you with the essential understanding of several fundamental statistical tools for analysing data and enable you to understand what the output from these tools is telling you about your product or process. This, in turn, will give you powerful information that you can use to provide continuous trending and to drive quality improvement.

What You Will Learn

• How to visualise data
• The concept of statistical confidence
• The basis for the common statistical process control tools; such as control charts, process capability and linear regression
• How to use statistical software and interpret the outputs
• Where these simple tools and techniques can be used to add value, eg in Product Quality Reviews, to provide continuous process verification, etc
• Case studies from pioneers who are already using these tools to good effect

Course outline

Summarising and Visualising Data

• How to present and compare data in ways that make understanding easier

Confidence in Your Means and Proportions

• Explains the importance of calculating ‘confidence intervals’ not just means

Control Charts

• How to draw and understand the most common Statistical Process Control tool for trending data

Cusum Charts

• Explains the control chart that magnifies gradual trends

Fishbone Diagrams and Pareto Charts

• Simple tools for performing cause and effect analysis

Process Capability

• Explains how to determine if a process is capable of consistently meeting pre-defined specifications

Regression Analysis

• How to analyse stability data

Discussion and Working in Groups

A significant proportion of course time will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice.

Additionally, discussion periods, including a course tutor panel session, provide delegates with an opportunity to obtain answers to their specific questions and concerns.

Venue

Manchester Marriott Victoria and Albert Hotel, Manchester, UK

The Manchester Marriott Victoria & Albert Hotel stands on the banks of the River Irwell, near the city centre but convenient for Manchester Airport (19km), the city’s Piccadilly rail station (3km) and the UK’s motorway networks.

Recently lovingly restored, this Grade II listed building bears many modern features. The hotel has its own car park and a few minutes’ walk takes you to the city’s main shopping and eating district.

Hotel Accommodation

• Online early booking offer – we have negotiated a discounted bed and breakfast rate including free wi-fi.
• To take advantage of this offer, you must book via a special weblink, details of which will be provided to you on receipt of a completed booking form.
• This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
• If you need any help or guidance with the accommodation booking process, please contact our course administration team.
• Your account with the hotel should be settled at check-out.
• 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 you are aware of the hotel’s cancellation policy.

Tutors

We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.

Our experts for this course are:

Guest Speaker – Professor of Statistics

• 

  Mr Peter Gough
  Partner
  MSc, CSci, CChem, FRSC, FCQI, CQP

  • [email protected]
  • +44(0)1751 432999

What you've said

“Course content was excellent and very beneficial to my job in QC. Knowledge of course lecturers/experts was brilliant and they were very helpful. Another very impressive and excellent course by DBA.”

Alana Kennedy, Warner Chilcott, UK

“Good balance between presentations and workshops. Good learning atmosphere.”

Hoa Vuong, F Hoffman-La Roche, Switzerland

“The course was very interesting. I think that it will be easier for me to use appropriate tools and understand them!”

Anne Wunenburger, F Hoffman-La Roche, Switzerland

“Very good structure of the course. A great interchange of comments between tutors – much better than a one tutor course.”

Robert Mika, Genzyme, UK

“You got the balance just about right between complexity/simplicity.”

Peter Owen, Genzyme Diagnostics, UK

“Excellent course. Practical element was excellent in reinforcing the principles learned.”

Teresa Lydon, Medtronic Galway, Republic of Ireland

“Course really helped in how to deal with data and analyse these data.”

Kees van Bijsterveld, Amgen Europe, The Netherlands

“High expertise of trainers. Practical approach appreciated. Good benchmark of the industry and current regulators considerations.”

Olivier Wallez, GSK, UK