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A Hybrid Early-Phase Manufacturing Option – Cutting Timelines by 50%

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Join Ravi Samavedam and Daniel Skypeck as they walk you through a novel solution for early-phase GMP manufacturing, which accelerates phase-appropriate manufacturing through the utilization of on-demand cleanrooms.

 

Together, they will explain the business model as well as technical aspects of a new hybrid concept for companies looking to transition into GMP manufacturing.

This webinar will also feature a case study around this environmental monitoring strategy and approach for the facilities in Waltham, MA.

 

What You’ll Get at this Webinar:

  • Azzur’s innovative solution to increasing demand for clean space and GMP expertise
  • Value proposition of Cleanrooms On Demand versus traditional approaches to early phase manufacturing (self-owned facilities or CDMO/CMOs)
  • Environmental Monitoring of Multi-product Facility – A Case Study

Click Here to Register

 

 

Speakers

Ravi Samavedam

President, Azzur Cleanrooms on Demand LLC.

Ravi Samavedam has about 20 years of experience in the biopharma industry with expertise in the process validation lifecycle, technology transfer, quality systems implementation, CMC and auditing. Prior to Azzur, Ravi has worked at Amgen, Baxter and Shire in areas including Technical Operations, Validation and Quality.

Daniel Skypeck

Quality Manager, Azzur Cleanrooms on Demand LLC.

Daniel Skypeck has 15 years combined experience in the biopharma industry with expertise is quality control and quality assurance. He is a certified Quality Engineer and Six Sigma Green Belt through the American Society for Quality. Prior to Azzur, Daniel has worked for Amgen and Alexion in areas of QC microbiology, raw material program management, and implementation of operational excellence initiatives.