Register now and join our Workshop!
When: October 10: 9:30am CET – 15:30pm CET
Hotel NH Collection Milano Touring
Via Ugo Tarchetti, 2, 20121 – Milano, Italia
The latest update of the EU GMP Annex 1 expands the regulations for container closure integrity in sterile pharmaceutical products. This has triggered new and improved industry best practices for container closure integrity testing (CCIT). The Lighthouse workshop serves as a roadmap to compliance; guiding CCIT strategy and practical implementation. The workshop will feature presentations by CCI Application Experts and in-depth laboratory demonstrations that offer participants valuable hands-on experience and deeper insights.
- The new CCI requirements in EU GMP Annex 1.
- Case studies and examples to cover the CCI topics in EU GMP Annex 1 for vials, syringes, cartridges, bottles and cryo tubes.
- A science-based holistic approach to cover CCI over the complete product life cycle, starting from development all the way up to final product testing.
- Detection of temporary leaks for freeze dried products and products requiring cold storage.
- The basics of laser-based headspace analysis as a CCI testing solution.
- Hands-on experience with CCI test methods using headspace analysis for various product types and packages.
- Hands-on experience with vial sealing characterization and raised-stopper detection.
The offer includes the workshop, food and beverages.
The ticket price includes VAT upon checkout.
(places are limited so please book early to avoid disappointment)