Ensure your manufacturing process is ready for PPQ and commercial launch
Successful process performance qualification (PPQ) and commercial launch requires planning well before manufacturing registration batches. This webinar is the second of a 2-part series focused on the recommended studies from a technical transfer group perspective that should be conducted pre-product registration and post registration to ensure a reproducible and scalable manufacturing process during PPQ and commercial launch.
Whlie the first webinar addressed studies for pre-registration, this webinar is the second part in a two-part series in which we go through a comprehensive list of recommended studies to ensure that the manufacturing process is ready for PPQ and commercial launch. This second installment will build off the risk mitigation concepts and suggested studies from Part 1: “Preparing for Registration.” The second part will guide the audience through suggested plans for the registration campaign including testing protocol on registration batches. We will also discuss how pre-registration data and process risk assessments can be employed to develop an efficient plan for commercial scale up.
Do you have questions about how best to prepare for a registration campaign? Do you know the most effective testing protocol for registration batches? Are you concerned with the integrity of your data? This is your chance to get your pre-registration and scale-up questions answered. Join us for this engaging webinar as the presenters explore these issues and provide examples and information from years of real-world in pre-registration manufacture.
Key Learning Objectives
- How to employ previous pilot studies and process design space to plan registration campaign
- Overview of testing protocol for registration campaign
- High-level overview of the scaleup and qualification process for commercial launch
- Developing scaleup up studies using risk-based approach
