Webinar: Is There a Gap in Your Process Validation?

Sponsored by: Parker Hannifin

Focused on:

  • Process Validation
  • Single Use Process

Date: 14 November

Days to go: 26

Time: 3PM London/10AM New York

Eliminating the Weak Link

Materials used in single-use will often be exposed to a range of pressures temperatures and solutions. Unless a validation package covers all those aspects your process could be placed at risk due to unexpected material behaviours, for example, ultra-low temperature storage.

During this webinar, we will describe how the vendor-user relationship has evolved over time. We will then go on to show, through a case study, the importance of understanding the full life cycle of a single-use system. In one assembly alone we identified 4 aspects that would not have been picked up during the design of the assembly but would have a major influence on its performance.

By sharing the validation work from this case study, we will demonstrate the need for a holistic approach to single-use assembly design and highlight the thought processes that a user will need to go through at critical steps in their project to avoid unnecessary product losses.

Sign up today to find out how you can ensure your critical assemblies are fit for purpose throughout the supply chain.

Presented by

Guy Matthews,

Market Development Manager

Guy Matthews has worked in the biopharm industry for the last 20 years starting his career as a Scientist at a well-known CMO in the UK before moving to more commercial roles.

During this time he has been involved in many projects implementing single-use technology in both upstream and downstream bioprocessing.

At Parker, Guy is focused on bringing Parker’s expertise in motion and control to bioprocessing to create robust solutions in single-use technology that enable customers to improve the quality and accessibility of biopharmaceuticals

Key Learning Objectives

  • Understand the changing nature of the vendor-user relationship with respect to single-use validation
  • Understand the factors that should be considered when validating a single-use process
  • Find out how to increase performance through consideration of broader design elements
  • Learn how to ensure single-use assemblies are validated for the entire supply chain.

Audience

  • Purification Scientists
  • Downstream Process Development
  • Upstream Process development
  • Operations Managers
  • Manufacturing Science and Technology
  • Automation Engineers
  • Facilities Manager
  • Quality Assurance