Examining Contamination Control Strategy in Primary Packaging - A Case Study

Join us to learn more and engage in a conversation with the West Pharmaceutical Services team to learn how primary packaging component quality contributes to a robust contamination control strategy.

Register Free: https://www.pharmtech.com/pt_w/examining-contamination

Event Overview:

As the saying goes, “You are only as strong as your weakest link.” This holds true 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 suppliers to create and maintain a holistic CCS that covers 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 discussion will also assess 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.

Key Learning Objectives:

• Learn about West’s approach to evaluating and maintaining a holistic CCS for elastomeric packaging components.
• Translate the elastomeric packaging components CCS theory into actual practice.
• Explore how NovaPure® helps manage uncertainty and minimize quality risks of particulate matter and performance via a QbD approach.

Who Should Attend:

• Those with roles specific to:
  • Device Development
  • Regulatory
  • CMC
  • Combination Products
  • Research and Development (R&D)
  • Quality
  • Engineering
  • Product Development
  • Technology Expert Combination Products
  • Operations

Speakers:

Niamh Bissett
Director, Operations PMO
West Pharmaceutical Services

Niamh Bissett 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. She also leads Global Initiatives across the Containment & Device Organizations within West Pharmaceutical Services, in the focus areas of Intermix, Contamination Control and Risk Management.

Prior to Niamh’s current role, she has held a variety of positions in both Quality and Program Management NPI, at the West Pharmaceutical Services, Dublin. Niamh has a Bachelor of Arts (Hons) degree in Information Systems Technology from Atlantic Technological University, Sligo, Ireland.

Ana Kuschel, PhD
Principal Scientific Affairs
West Pharmaceutical Services

As Principal Scientific Affairs Europe, Ana Kuschel, PhD provides technical support relating to West’s packaging components and delivery systems for injectable drugs and healthcare products. She plays a key role in bridging scientific information through industry outreach. This complements her previous role as Manager of 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.

Register Free: https://www.pharmtech.com/pt_w/examining-contamination