In this free webinar, learn how a holistic science-based approach can be used to assure the container closure integrity of sterile drug products and comply with new regulations. Attendees will learn how to interpret the new container closure requirements in the new EU GMP Annex 1. The featured speaker will discuss how to develop deterministic analytical methods for container closure integrity testing. Attendees will see examples of design packaging studies that generate robust science-based data demonstrating good container closure integrity.
TORONTO, Ontario, Canada, April 19, 2023 /PRNewswire-PRWeb/ -- Container closure integrity (CCI) is a critical quality attribute for finished sterile drug products. The new EU GMP Annex 1 contains new requirements for the container closure of sterile pharmaceutical products. These requirements have triggered new best industry practices in the area of container closure integrity.
In this webinar, the featured speaker will review the new requirements and describe a practical road map enabling compliance: Implement a deterministic analytical method for container closure integrity testing; Methods based on laser-based headspace analysis enable the generation of robust science-based packaging data during the product life cycle as required by the new Annex 1; And the execution of packaging studies which demonstrate the achievement and maintenance of good container closure, and enable the design of an appropriate testing strategy.
Join this webinar to understand how a holistic science-based approach can be used to assure the container closure integrity of sterile drug products and comply with new regulations.
Join Derek Duncan, PhD, Director, Lighthouse Instruments, for the live webinar on Tuesday, May 9, 2023, at 10am EDT (4pm CEST/EU-Central).
For more information, or to register for this event, visit Container Closure Integrity: Meeting the New EU GMP Annex 1 Container Closure Requirements.
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Contact:
Vera Kovacevic
Tel: +1 (416) 977-6555 x371
Email: [email protected]
Media Contact
Vera Kovacevic, Xtalks, +1 (416) 977-6555 x371, [email protected]
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