- Process Validation + Statistics (AKL-7/8-02-19)
07/02/2019 - 08/02/2019
9:00 am - 4:00 pm
Day 1 – Process Validation Training
This Process Validation training course is designed to provide an overview of the latest concepts and guidance documents for Process Validation as issued by the US FDA in 2011 and the EU and PIC/S Annex 15 in Qualification and Validation in October 2015. The aim of the course is to provide practical insights into how “modern process validation” is carried out and avoid common and costly mistakes.
The US FDA and EMA have different approaches to Process Validation. Understanding these approaches will provide your team with the best opportunity to develop and implement your own compliant validation approaches, and of course manufacture or deliver safe products to your customers.
Day 2 – Statistics for Process Validation Training
Statistics may not be for everyone but they are a fundamental part of GMP and all stages of process validation.
We have developed an interactive course that will keep you engaged throughout the day as you develop a practical understanding through workshops and discussion of statistics in process validation including understanding variability, statistical inference, Design of Experiments (DoE), control charts and more.
Venue: Novotel Auckland Airport
Novotel Auckland Airport
The 4-star plus comfort of the Novotel Auckland Airport hotel is conveniently located outside the international terminal and is a 30 minute drive from the CBD.
All communal areas have wireless internet access.
The Novotel Auckland Airport has public car parking available.
All rooms are fitted with full-length soundproof windows. The on-site restaurant caters for breakfast, lunch and dinner.
The greenery of the bar’s “living wall” is a great place to relax.
City information: Auckland, New Zealand
Central Auckland is home to world-class shopping, buzzing waterfront precincts lined with restaurants, a vibrant arts and culture scene and harbour adventures.
The wider region has restaurants, bars and galleries encircled by wine regions, stunning beaches, pristine rainforest and the magnificient Hauraki Gulf.