Transitioning from Clinical to Commercial Manufacturing -- Part 1: Pre-Product Registration Perspective, Upcoming Webinar Hosted by Xtalks
In this free webinar, the featured speakers will provide a high-level overview of the scale-up and qualification process for new product launch in a two-part series. In part one of the series, the focus will be on studies for pre-registration activities. Attendees will learn about risk-based approaches to mitigating scaleup issues prior to registration and common issues that arise between registration and qualification (scale-up). Also learn about what data to collect and evaluate during registration batches and other considerations for registration manufacturing.
TORONTO, Jan. 20, 2022 /PRNewswire-PRWeb/ -- Successful process performance qualification (PPQ) and commercial launch requires planning well before manufacturing registration batches. This webinar is the first of a two-part series. The series will focus 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.
This first part of the webinar series will focus on studies for pre-registration activities. Registration manufacturing is critical to a product's regulatory filing, creating the proposed process for commercial manufacturing. Through the use of risk-mitigation techniques and understanding regulatory requirements upfront, critical studies can be identified prior to registration manufacture that will de-risk the scale-up process.
Do you have questions about process performance qualification or tech transfer in general? Are you wondering what steps you need to take to ensure successful registration manufacture and commercial launch? Join this engaging webinar as the presenters explore these issues and provide examples and information from years of real-world experience in pre-registration manufacture.
Join experts from Mayne Pharma, Harry G. Cocolas, PhD, Senior Director of Technical Services, Anshul Gupte, PhD, Senior Director of Scientific and Technical Affairs; and Kyle D. Fugit, PhD, Associate Director, Technical Transfer, for the live webinar on Thursday, February 10, 2022 at 11am EST (4pm GMT/UK).
For more information, or to register for this event, visit Transitioning from Clinical to Commercial Manufacturing — Part 1: Pre-Product Registration Perspective.
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Ayesha Rashid, Xtalks, +1 (416) 977-6555 x 272, [email protected]
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