We have been asked by several customers to hold a seminar on stability testing again in accordance with ICH guidelines. It will again be Michael Holzwarth from Weiss PharmaTechnik who will hold the seminar and he will share his many years of experience and enormous expertise in the field. At the seminar, we review suitable products, theory and give participants a basic understanding of stability testing as well as the challenges related to ICH, GAMP; EU GMP Annex 11 and FDA 21 CFR part 11.

Agenda:
• Welcome and introduction by Weiss PharmaTechnik
• Modern stability tests in Pharma and Biotech companies
• Solutions for modern stability testing
• Qualification according to GAMP 5 and EU GMP Annex 15
• Dokumentation iht. EU GMP Annex 11 og FDA 21 CFR part 11
• We conclude with any questions and an open dialogue

Target group: Users, QC, QA managers, etc.
Date: Wednesday 17 April 2024
Place: Marielundvej 39, 2730 Herlev
Time: 9.30 - approx. 15.30 including coffee breaks and lunch.
Lecturer: Michael Holzwarth, Weiss PharmaTechnik
Language: English
Participation fee: Free  
For more information and registration: Anders Lillesø at tel. +45 44 54 00 21 or at e-mail: al@buch-holm.dk  
  
We know what it takes and look forward to an exciting day with you.