Getting your product to the patient: what to know about labeling, kitting, storage, & distribution скачать в хорошем качестве

Getting your product to the patient: what to know about labeling, kitting, storage, & distribution

Sign up for other webinars in this series here: https://berkshiresterilemanufacturing... About this event: What happens after your drug product is manufactured? Can your CMO label, package, and store your drug product? What details do you need to have ironed out before you ship your product? In this webinar, we team up with Sharp to answer all of your questions and more to give you an end-to-end overview of your drug product manufacturing process. We will give a brief overview of the sterile fill finish process then an in-depth review of the transfer process to a packaging and distribution company with special considerations for high-value and unstable drug products. Sharp will then take the stage to discuss decisions you will need to make in labeling, QP, and importation, and regulatory considerations when conducting clinical trials in Europe versus the United States. 00:00 - Intro 01:30 - Why are we discussing packaging? 04:01 - Topics covered 04:22 - Common customer and CMO questions 06:40 - IRT/IMS system 08:44 - Comparator sourcing 15:15 - Secondary packaging 18:01 - Labeling 22:04 - Qualified Person (QP) 24:58 - Storage & distribution 30:15 - Recommendations 31:34 - Transition to Q&A 32:38 - Q&A 34:55 - Conclusion