Safeguarding Patients: Supplier Process Validations

In this webinar, DDL’s Executive Engineer, Abhishek (Abhi) Gautam focuses on safeguarding patients through the validation of processes used by suppliers, particularly in the healthcare packaging industry. This topic addresses the ongoing debates between medical device manufacturers and suppliers about who is responsible for process validation on the supplier's side. The presentation centers on the validation of Sterile Barrier System components used in packaging, but the insights gained can be applied to other areas of the medical device industry.

The goal of the webinar is to establish a common understanding of supply process validation and explore topics such as risk, compliance references, and key validation elements. A practical example is provided to illustrate the challenges faced by manufacturers and suppliers in handling validation responsibilities. The webinar includes scenarios and considerations to ensure clarity on ownership and compliance.

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