Examining Contamination Control Strategy in Primary Packaging

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Summary
Speakers

As the saying goes you are only as strong as your weakest link, and this goes for today’s Contamination Control Strategies (CCS). As drug manufacturers assess their CCS, one must inevitably consider the quality and control of materials from third party suppliers that enter the aseptic process. A critical success factor to a CCS is the ability of your suppliers to create and maintain a holistic CCS covering all aspects of the manufacturing operation, including environmental control, validation and monitoring, quality systems, and processes.

This free webinar will explore lessons learned from West, a supplier of high-quality packaging components and devices, as it addresses EU GMP Annex 1 requirements through the implementation of a comprehensive CCS across its global network to ensure best practices and continual improvement. The talk will also demonstrate how Quality by Design (QbD) principles and manufacturing controls are applied to West NovaPure® stoppers and plungers ensuring a consistent and predictable level of contamination control.

Ana Kuschel

Principal Scientific Affairs, West Pharmaceutical Services

As Principal Scientific Affairs Europe, Ana is providing technical support relating to West’s packaging components and delivery systems for injectable drugs and healthcare products. As well as bridging scientific information through industry outreach. This is complementing her previous role as Manager Material Development, where she worked on both existing and new rubber formulations. Ana holds a PhD in macromolecular chemistry and is an active member of the ISO TC 76 and PDA Packaging Science groups.

Niamh Bissett

Director, Operations PMO, West Pharmaceutical Services

Niamh has over 20 years of experience in Quality Compliance and Program Management. In her current role as Director Operations, PMO, Niamh provides strategy, vision, direction and support for the Program Management Organization and leads Global Initiatives across the Containment & Device Organizations within West Pharmaceutical Services, in the focus areas of Intermix, Contamination Control & Risk Management. Prior to Niamh’s current role, she has held a variety of positions in both Quality & Program Management NPI, at the West Pharmaceutical Services, Dublin facility. Niamh has a Bachelor of Arts (Hons) Degree in Information Systems Technology from Atlantic Technological University, Sligo, Ireland.

Examining Contamination Control Strategy in Primary Packaging - A Case Study