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Informa
08:30 - 09:40 70 mins
Registration
09:40 - 09:50 10 mins
Chairperson's Opening Remarks
09:50 - 10:20 30 mins
Hot topics and challenges in raw materials for biologicals
  • Dominic Moore - Director, Quality Control Raw Materials Group, Sanofi Genzyme
10:20 - 10:50 30 mins
Feedback from the BPOG Raw Material Variability Workstream
  • Aaron Mack - Engineer III, Biogen
10:50 - 11:20 30 mins
Spotlight presentation - GE Healthcare
11:20 - 12:10 50 mins
Morning Coffee and Networking
12:10 - 12:40 30 mins
Info
Feedback from the ISIA on the use of serum in manufacturing
  • Rosemary Versteegen, PhD - CEO, ISIA
  • Serum/ removal of the use of serum
  • HPV concerns and considerations
  • Reg recommendations 
12:40 - 13:10 30 mins
Spectroscopic online monitoring methods to identify the impact of preparation parameters and raw materials on chemically defined cell culture media quality
  • Andreas Unsöld - Head of Cell Culture Media, Boehringer Ingelheim
13:10 - 13:40 30 mins
Info
Utilizing the Joint Audit Approach for Single Use Systems
  • Jim Fries - CEO, RX-360

Background:

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.


Methods:

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:

  • The delivery of final audit report within 30 business days
  • The number of times a completed audit is licensed
  • CAPA compliance (20 days)
  • Reduction in supplier audit burden as measured by planning time, hosting time, responding to and reviewing multiple audits and all associated costs.
  • Survey feedback from participants
  • Observations identified during Pilot as categorized as Potentially Critical and/or Other.


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. 


Presentation Goal:

To provide an Overview of entire program and for the first time publicly present results of the initial phase of the Pilot.

13:40 - 14:10 30 mins
Spotlight Presentation
14:10 - 15:25 75 mins
Lunch and Networking Break
15:25 - 15:55 30 mins
Info
Sourcing strategies – quality audits and vendor oversight
  • Feedback on how to conduct quality audits
  • Primary vs. secondary – how deep to go
  • Reduced sampling and how to deal with this
15:55 - 16:55 60 mins
End of day Q&A/ Session wrap up
16:55 - 17:00 5 mins
Opening of Exhibition Hall & Networking Drinks