A Practical Road Map for Compliance to the Container Closure Requirements in the New EU GMP Annex 1

Learn practical steps to achieve compliance to the container closure requirements in the new EU GMP Annex 1.

Register Free: https://www.pharmtech.com/pt_w/practical-road-map

Event Overview:

The new EU GMP Annex 1 contains new requirements for the container closure of sterile pharmaceutical products. These requirements will trigger new best industry practices in the area of container closure integrity. This webinar will review the new requirements and describe a practical road map enabling compliance:

• Implement a deterministic analytical method for container closure integrity testing.
• Such a method enables generation of robust science-based packaging data as required by the new Annex 1.
• Design packaging studies which a) demonstrate the achievement and maintenance of good container closure, and b) enable the design of an appropriate testing strategy.

Key Learning Objectives

• Learn how to interpret the new container closure requirements in the new EU GMP Annex 1.
• Understand how to develop deterministic analytical methods for container closure integrity testing.
• Understanding how to design packaging studies that generate robust science-based data demonstrating good container closure integrity.

Who Should Attend

• Manufacturing representatives responsible for compliance to the EU GMP Annex 1
• QC representatives responsible for container closure integrity testing
• Packaging and process development representatives

Speaker:

Derek Duncan, PhD
Director
LIGHTHOUSE Instruments

Dr. Duncan began his career at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He moved into industry holding Product & Application Development positions. Currently at LIGHTHOUSE since 2003, Dr. Duncan is responsible for developing applications for process monitoring and finished product inspection. These include using headspace analysis for 100% container closure integrity testing, lyo chamber moisture mapping, and automated media fill inspection.

Register Free: https://www.pharmtech.com/pt_w/practical-road-map