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QP Module 6: Mathematics & Statistics

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The Pharmaceutical Industry and the Regulatory Authorities are becoming increasingly aware of the benefits that statistical techniques can provide

Dates: Monday 16 to Thursday 19 September 2013
Venue:
York Marriott Hotel, York, UK
Cost:

£2560.00 excl. VAT – £3072.00 incl. VAT

Type:

About this course

The introduction of the EU requirement for Product Quality Reviews, ICH Q8, Q9, Q10 and Q11, and new guidance from both the FDA and EU on Process Validation, which includes ‘continued process verification’, all mean that the Pharmaceutical Industry and the Regulatory Authorities are becoming increasingly aware of the benefits that statistical techniques can provide and the vital information that can be obtained by trend analysis. This module assumes that delegates have little or no experience in the application of statistical techniques and will demonstrate how simple statistical tools can be used to turn data into useful information.

The provision of useful information is essential to the Qualified Person and other professionals in helping them to:

  • Understand the reliability and accuracy of data and information arising from samples taken from a population
  • Monitor and detect adverse trends before a process goes out of control
  • Assess the capability and reliability of a process
  • Understand the interaction of process parameters via experimental design
  • Maintain regulatory compliance

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A word from NSF Health Sciences

If you do not find the course you are looking for please contact me at the NSF Health Sciences Kirkbymooorside Office

Bev Willett, Course Administrator, NSF Heath Sciences

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