at City Convention Centre
Thursday, 20 April 2017 from 12:30 PM to 5:00 PM (AUS Eastern Standard Time) + Add to calendar20/04/2017 12:3020/04/2017 17:00Australia/SydneyMelb - Introduction to Statistics for ValidationMelb - Introduction to Statistics for Validation
Thursday, 20 April 2017 from 12:30 PM to 5:00 PM (AUS Eastern Standard Time)
Organiser
Mandy Bromilow
0447279008
manager@ispe.org.au
Address
City Convention Centre
300 Flinders Street
Melbourne
Melbourne 3000 Australia
Level 12
Event web page: https://www.stickytickets.com.au/49731City Convention Centre
300 Flinders Street
Melbourne Melbourne 3000
AustraliaMandy BromilowfalseDD/MM/YYYY2880
Tickets for this event are currently unavailable
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:
300 Flinders Street Melbourne Melbourne 3000, Australia
Mandy Bromilow
ISPE
0447279008