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Highly defined bioproduction processes and the higher analytical resolution capabilities possible today allow for a much greater understanding of sources of variation and potential for risk mitigation. An integrated, risk-based raw material characterization program is presented, including case studies illustrating how sources of variation affect process outcomes and actions that can mitigate risk and reduce process variation.
The BioPhorum Group in conjunction with Rx-360 have identified the current value of joint audits throughout the industry. In an effort to bring the joint audit model to single use systems. The purpose of the pilot is to validate the joint audit model within the auditing process of single use systems. Through this Pilot BPOG and Rx-360 will also be able to validate best practices around cost effect, quality based joint audits and the alleviation of supplier burden during the audit process.
Rx-360 and BioPhorum will utilize BSI to conduct the audits that are scheduled within the Pilot. The Pilot is being driven by a Steering Committee that is made up of members of all three organizations. Those members will collaboratively drive the Pilot planning stage through analysis of data, and implementation of best practices or improvements. The Pilot will identify “Reviewers” who will take on the traditional role of cosponsors of the audit, as described within the current Joint Audit Model. The Pilot will be made up of 12 audits that will be broken up into 4 “sprints or sections of 3 audits each. Key measures that will be tracked during Pilot are:
Outcome of Pilot:
Upon completion of the Pilot, a collaborative team identified by Rx-360 and BioPhorum will write a consensus paper (to be published) that will provide the results, and data of the Pilot.
To provide an Overview of entire program and for the first time publicly present results of the initial phase of the Pilot.
Topics like Digitalization and Industry 4.0 are currently on everyone's minds. New economy companies revolutionizing more and more classical business models. Aviation, like other safety sensitive industries, is working hard to keep up. Unlike services from the big role models out of e.g. Silicon Valley, aerospace products cannot and will not shipped in Beta status. This presentation will show examples how Lufthansa is addressing these challenges.