ISPE NORDIC
CLEANING VALIDATION CONFERENCE

PREREQUISITES FOR CLEANING VALIDATION

“How to Prepare for Cleaning Validation”

20 April 2016 – 08:00-17:00
Ottiliavej 9 (att H. Lundbeck), 2500 Valby, Denmark

 Hlu

Cleaning Validation and Cross Contamination have become the hottest topics since the update of EU GMP volume 4, chapter 3 “Premise and Equipment” and chapter 5 “Production” plus Annex 15 “Qualification and Validation” was released last year.

The cleaning validation has come a long way since the first FDA guidelines were published in 1991. Microbiological contamination has been identified as a root cause to 642 recalls from 2004-2011. Cross contamination and risk evaluations are in focus.

This conference will focus at the updates in the regulatory requirements, the EMA guideline on setting health based exposure limits, explain the concept of “toxicology” and how to use PDE for the MACO calculations. how to develop cleaning processes, how to work with multipurpose equipment and how to implement cleaning and sterilization equipment Both from the theoretically and the practically aspect. We brought in speakers from both local area and from abroad. Each experts within their field.

Programme ( 1 MB)

Download the conference programme here and learn more about the conference and the speakers.And please share the programme with people in Your network, who also could benefit from this ISPE Nordic conference

Who should attend?
In general people working with pharmaceutical Cleaning and Cleaning Validation, such as Process Engineers, Microbiologists, Project Managers, Quality Engineers, Quality Assurance and regulatory inspectors.

Register online for the conference.

 Register Now!

It is possible to have a small table top exhibition at this conference. If You are interested, You order Your booth together with Your registration for the conference.

The conference will be held in the auditorium at H. Lundbeck. Parking can be done just outside at the road “Krumtappen”

 Map

Questions regarding the event can be addressed to:
Charlotte Kroyer, Xellia Pharmaceuticals,
Phone: +45 22 56 48 45, E-mail: charlotte.kroyer@xellia.com