Life Science Process Validation – Copenhagen’s Risk, Science, and Data-driven networking group
Road Map to a Good User Requirement Specification, IDA Conference Centre, Copenhagen
POSTPONED TO AUTUMN 2020- TENTATIVE DATE 21st September
Later in 2020, ValidEire is hosting Life Science Process Validation – Copenhagen’s Risk, Science, and Data-driven networking group
The event is happening in Copenhagen at IDA conference center (visit this link for more information)
With experienced Process Validation speakers/ workshop hosts from both local companies including AN Group, Alfa Nordic, Medico Support and International Novatek International.
Process Validation in the Life Sciences is an industry network group based in Copenhagen.
How do we differ from global groups like ISPE or PDA? The answer is that we are not a non-profit organization and not sponsored by corporate entities. Our members’ needs, experience and engagement drive the happenings within the network. ValidEire serves only an administrative function.
An annual membership fee of 2500 DKK or 335 Euros including VAT covers administrative costs, planning meetings and participation in two separate full day Process Validation workshop-type events. Alternatively there is a per workshop fee of 1500 DKK or 200 Euros including VAT.
In this Full Day Course you will work with the course leaders to develop a deeper understanding of the application and benefits of risk based approaches to facility fit and specifically writing good URS documents. The day will consist of short presentations by the course leaders followed by Q&A. I
Part 1 – Pre-requisites to writing a Good URS
Part 2 – How to Create an Equipment Risk Assessment
Part 3 – URS and the Equipment Lifecycle
Part 4 – Workshop: URS Writing / Case Study
Aseptic Manufacturing- Maintaining the validated state
21st-22nd October 2020, Industriens Hus, H. C. Andersens Boulevard 18
1553 København V, Copenhagen.
(Including Process Validation, Contamination Control, Environmental Monitoring and Sterilisation)
This two-day intensive summit brings together the industry leaders in compliance, aseptic manufacturing and maintaining the validated state. The conference will go beyond presentations on best practice and consists of both presentations and workshops on different aspects of aseptic manufacturing. Attendees will therefore gain a deeper understanding of the new messages from the new Annex 1 draft, FDA focuses on inspecting sterile facilities, sterilisation, process validation, life cycle approach and more.
Science, Risk and Statistics-based Cleaning Process Development and Validation
6th-7th October 2020, Amsterdam, Netherlands
This two-day, intensive summit brings together the industry leaders on science and risk- and statistics-based cleaning validation. The conference will go beyond presentations on best practice and consists of both presentations and workshops on different aspects of cleaning validation. Attendees will therefore gain a deeper understanding of the new ASTM E3106 Standard, use of statistics in cleaning validation, as well as risk evaluation and data integrity in cleaning validation – among other things.
In addition to the many presentations and workshops, the conference will also provide many opportunities for networking.