Recorded Webinars
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.
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Safeguarding Patients: Test Method Validations
In this insightful webinar, DDL’s Executive Engineer, Abhishek Gautam (Abhi), delves into the critical importance of test method validations within the healthcare packaging industry. Abhi highlights the widespread misunderstanding and inadequate execution of these validations, underscoring their profound implications for patient safety. Key points discussed include the necessity of comprehending the impacts and risks associated with test method validations, considerations such as equipment validation and sample preparation, the imperative of an unbiased testing environment, compliance with industry standards, and the development of tailored internal protocols.
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Designing a Pre-Filled Syringe Test Plan: A Practical Guide to Performance Testing
Companies developing pre-filled syringe combination products are often put in a bind when it comes to timing and execution of design verification studies. All too often, product rolls off the manufacturing line and then is rush shipped to testing sites for expedited service. Working with a test lab that is seasoned, responsive and flexible can certainly make these hectic situations less severe for the entire program. This information-rich webinar highlights DDL’s best practices for ensuring a test program is established on firm ground and executed flawlessly.
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