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ISPE is pleased to present workshop" Introduction to Statistics for Validation " for those wishing to attend the upcoming three-day ISPE PV training to be held in Sydney on 1st - 3rd May 2017 and/or for those wanting to refresh their statistical knowledge.

Overview:

In 2011 the US FDA published new guidance for process validation requiring a lifecycle approach and mandating increased focus on control of process variability. Shortly after this EMA and PIC/S issued new and similar guidance on validation. These new requirements are predicated on ICH guidance for development practices and risk management as well as sound understanding of processes and the use of scientific tools.

Application of appropriate statistical tools and understanding of the assumptions underlying in their use is a key factor in this new paradigm of validation and in continued process verification.
This workshop is intended to provide a basic introduction to statistical tools, which may be used in qualification and validation activities. The material covered is not intended to be a tutorial in the use of these techniques; rather it will cover an overview of the basis and application of commonly used statistical tools including:

  • Introduction to descriptive statistics; means, variation, standard deviations, variables, attributes and probabilities.
  • Confidence and tolerance interval estimation
  • Process capability: How to calculate Cp, Cpk, Pp, Ppk, and what these measures mean in terms of process performance.
  • Control Charts: design of control charts; control chart rules. Situations where you should use different types of chart.
  • Sampling: How to derive sample sizes by various methods and when you might use different techniques.
  • Assumptions underlying the use of statistics including limitations of the normal distribution, the practicalities of use of statistics in pharma manufacturing. Risk in sample size, special case variation and how to interpret Minitab (or similar) information from software packages.
  • Traps pitfalls and when to call in a statistician…
Who should Attend?
This course is relevant to individuals involved in process validation of products and processes in all sectors of the pharmaceutical industry including Development, manufacturing, engineering, quality, and validation professionals with intermediate level experience in development, manufacturing, engineering, validation, quality, technology transfer and those wishing to understand the statistical techniques applicable to lifecycle process validation.

Presenter:
Maurice Parlane, Director, CBE Pty Ltd, and New Wayz Consulting Ltd. is a professional engineer with 29 years’ experience in technical and consulting roles within the biopharmaceutical industry, including 19 years as an industry consultant. His core skills and experience are in manufacturing and compliance management; process design and improvement; validation and operational excellence. Maurice has assisted numerous organisations to establish, improve or scale-up manufacturing operations in Australasia and the Asia Pacific region. Prior to this; he held senior engineering and manufacturing roles within the Glaxo group of companies. He has a Bachelor of Manufacturing Technology (Hons) as well as mechanical and electrical engineering qualifications. Maurice is a past president and current director of the ISPE Australasian Affiliate, Chair of ISPE’s Asia Pacific Regulatory and Compliance Committee and an active member of the PQLI Process Validation Committee. He is a chapter lead in the development of ISPE’s Good Practice Guide for process validation.

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Location
City Convention Centre

300 Flinders Street Melbourne Melbourne 3000, Australia


Organiser Information
ISPE

Mandy Bromilow
ISPE
0447279008

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