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Azzur Group

Acceleration of Clinical Timelines Using Azzur Cleanrooms on Demand™, a Novel Approach to Biopharmaceutical Manufacturing
LIFE SCIENCES

Acceleration of Clinical Timelines Using Azzur Cleanrooms on Demand™, a Novel Approach to Biopharmaceutical Manufacturing

Current industry challenges and opportunities related to biopharma manufacturing Internal manufacturing capability establishment challenges for biopharma Challenges related to outsourcing of technology and process throughout product lifecycle The Azzur Cleanrooms on Demand™ model Case Studies — Ravi Samavedam Chief Innovation Officer Azzur Group Ravi Samavedam is a Biochemical Engineer with more than 20 years of experience in the pharmaceutical and biotechnology industries. Ravi joined Azzur in 2012, and prior to his appointment as CINO of Azzur Group, Ravi was the President and COO of Azzur Cleanrooms on Demand™ and previously served as  General Manager of the Boston-area consulting practice.  Prior…

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Avoiding the Pitfalls of Initial GMP Programming and Clinical Production Space Planning
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Avoiding the Pitfalls of Initial GMP Programming and Clinical Production Space Planning

Discussing the common pitfalls observed during establishment of initial GMP programs in the areas of quality systems, materials management, supplier qualification, etc. How are companies adopting organizational changes and leveraging digital systems to avoid these pitfalls? Important factors to consider when assessing build vs. buy for early-phase clinical production, and considerations for scaling a GMP program up and/or out Illustrating the importance of establishing clear process requirements and conducting informal and formal facility fit assessments using real-world examples — Chris Mansur President, Azzur Consulting Azzur Group Chris Mansur currently serves as the President of Azzur Group’s Consulting division, which specializes…

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