FREE SPONSORED WEBINAR - This webinar will cover the impact to defined Product Performance Specifications and User Needs, including the necessary updates to the drug dossier and technical documentation for inclusion in the submission packages.
Changes are required to approved drug products as part of the lifecycle. To accommodate an alternate primary package, e.g.: pre-filled syringe (PFS), they will often involve changes to technical requirements that have a regulatory aspect.
Impact to defined Product Performance Specifications and User Needs will be presented, including the necessary updates to the drug dossier and technical documentation for inclusion in the submission packages.
Learning outcomes
Participants will learn how to approach primary packaging change to appropriately consider that regulatory compliance and submission requirements are duly considered and planned for.
Audience
This presentation is aimed at regulatory professionals, engineers and project managers involved in Drug Product lifecycle management who wish to learn more about how to manage primary packaging changes involving devices.
Presenter
Mary Sinnott, Senior CMC Regulatory Consultant, Venn Life Sciences
Mary has over 24 years of experience in the pharmaceutical industry and medical device industries. She was involved in drug development projects as analytical scientist, and in managing Global product CMC regulatory strategy and maintenance for marketed products. Mary's experience includes Scale-up, Analytical Changes, Technology Transfer, Issue Management; writing, reviewing, and approving regulatory Quality and CMC submission documents. Notified Body audit & FDA inspection preparation and participation, Regulatory Knowledge Management, Benchmarking study, Business Process Definition
