About this Event
The newly updated EU GMP Annex 1 regulations now require that sterile pharmaceutical products comply with stricter container closure integrity (CCI) requirements. The workshop introduces Container Closure Integrity Testing, explains the background theory, compares this method to other methodologies, and describes how test methods can be developed and validated. Furthermore, detailed explanations of relevant guidance documents and regulations will be provided, like the USP Chapter <1207> and the new Annex 1 guidelines for CCI. In addition, there will be an in-depth demonstration of Lighthouse’s non-destructive headspace analyzers. Finally, the workshop will enable the participant to implement CCI testing strategies to ensure adequate drug product protection and comply with relevant regulatory requirements.
The fee includes attendee's hotel on June 4 and June 5. It includes breakfast, lunch and dinner on June 5 and breakfast and lunch on June 6. The hotel will provide breakfast.
The fee does not include airfare or transportation to Charlottesville.
Event Venue & Nearby Stays
2050 Avon Ct, 2050 Avon Court, Charlottesville, United States
USD 1975.00 to USD 2250.00
