Aseptic Process Sampling Risk Mitigation - A Regulatory Perspective

WEBINAR

Increasing validation requirements along with the raise of QbD and PAT have put sterile processes sampling under scrutiny by regulation bodies. Traditional sampling methods have reached their limits while closed sampling methods come of age. Beyond the need to ensure contamination control, the regulatory authorities require compliance in different aspects related to the sampling method of a drug.

This webinar will review the benefits attained from implementing single-use systems. In this objective, these authorities provide guidance on processes helping to reach these requirements (e.g. QbD, PAT, Process validation). Drug manufacturers have the possibility to respond to these expectations through the implementation of single-use systems, instead of common traditional sampling methods, which include the usage of glass bottles or SIP stainless steel valves.

Join this webinar to learn more about the recommendations and requirements stated by these major regulatory authorities regarding the monitoring of the manufacturing process with the execution of sampling. In addition, this webinar will include a review of the benefits attained from implementing single-use systems, therefore reducing the sampling risks compared to traditional methods.
In this webinar you will learn:

• Key drivers for Aseptic Process Sampling
• Complexity and Risks of Traditional Sampling Methods
• Regulatory Recommendations, Corresponding Needs, and how to get there