Rescop Event Benelux 2018
Compliance fit for the future
During the Rescop Event Benelux our Senior and Principal Consultants will share their knowledge and experience that they gained during the latest Governmental Inspections. This will help you get fit for the future!
We offer two different workshops at the Rescop Event Benelux: Life Cycle Process Validation & Cloud solutions and compliance. When you register for the event, you can indicate which workshop you would like to attend.
Life Cycle Process Validation
Process Validation has changed with the publication of the 2011 FDA Guidance for Industry “Process Validation: General Principles and Practices”, and the 2015 EMEA revised Annex 15 “Process Validation”. Health Agencies are nowadays demanding a new approach to Process Validation: “Life Cycle Process” with 3 stages:
• Process Design;
• Process Qualification;
• Continued Process Verification
With this, nowadays the focus must be on process knowledge and process understanding. Both should be a result of development and should lead to better designed manufacturing process with control strategies to be confirmed during PPQ and to be ongoing verified in routine production.
Cloud solutions and compliance
Cloud solutions are currently connecting to your local network or they even create an integrated network of cloud and local systems. At the same time pharmaceutical IT and quality professionals need to protect the compliance of the systems. Reducing risks and avoiding new ones is very important to pharmaceutical IT and quality professionals. Now that cloud computing models are well accepted in many sectors with proven security models and high reliability, it becomes a viable option for companies in the life sciences.
12h30 Welcome with coffee/tea and sandwiches
13h10 Biotech Training Facility
13h30 Presentation – Process to Infrastructure
14h00 Network break
14h30 Workshop Cloud solutions and compliance
What does outsourcing of technology mean to our validations?
14h30 Workshop Process Validation
How to ensure a process remains in a state of control?
16h00 Closure Official part and start Network drink
17h00 The end of an interesting afternoon
Date and location
Thursday 1st of November 2018
Rat Verlegh Stadion
For additional information or questions, kindly contact:
Phone: +31 (0) 85 201 72 77