Thought Leadership Series: Cleanroom round table

Join this FREE Thought Leadership Series webinar sponsored by AES Clean Technology and the Azzur Group

Date: Thursday, December 1st, 2022

Time: 10:00 PM (RIYADH)

             2:00 PM ET / 1:00 PM CT / 11:00 AM PT / 7:00 PM GMT

Sponsors: AES Clean Technology, Azzur Group

Duration: 1 Hour

REGISTER TODAY

Summary: With most regulators revising policies to provide clarity around best practices for the manufacture of sterile medicinal products, all eyes are on pharma cleanrooms. Drug manufacturers face a complex list of considerations when it comes to the design, build, qualification and operation of cleanrooms. Ultimately, investments made into cleanrooms will be significant, so it’s important to explore the pros and cons of all options before decisions are made.

Join our panel of cleanroom experts for a roundtable discussion that will cover: 

• DESIGN: Evaluating cleanroom goals— how to deliver predictable and repeatable performance in the most efficient and economical way 
• BUILD: Cleanroom construction — what are your options and the pros and cons of each? 
• QUALIFICATION: Making sure cleanroom qualifications meet new regulatory standards 
• OPERATION: New cleanroom technologies and how they can increase operational efficiencies

SPEAKERS

Ravi Samavedam | Chief Innovative Officer | Azzur Group

Ravi Samavedam is a Biochemical Engineer with more than 20 years of experience in the pharmaceutical and biotechnology industries. Prior to his appointment as Chief Innovation Officer at Azzur Group, he was President and COO of Azzur Cleanrooms on DemandTM. In 2019, Ravi was a General Manager of Azzur Boston, and has been with the company since 2012. Prior to Azzur, Ravi has been part of the Technical Operations, Quality/Validation departments at Baxter, Amgen, and Shire.

Ravi is an expert in phase-appropriate cGMP implementation, Process Validation, Supplier Management, and Technology Transfer. Ravi leads Azzur Cleanrooms on DemandTM in offering flexible early phase cGMP manufacturing options designed to mitigate risk and increase speed to clinic. In addition to his work with Azzur, Ravi is an active member of industry and peer groups, and he is a frequent speaker at industry events.

Mitchell Gonzales | Vice President Process Technology | AES Clean Technology

Mitch Gonzales is the vice president of Process Technology at AES Clean Technology, Montgomeryville, PA. He is a leader with 30 years of progressive experience in the biotechnology, biosimilar, gene therapy and pharmaceutical industries. His experience is centered on aseptic biopharmaceutical Operations (e.g. engineering, manufacturing, clinical development, supply chain, technical transfer) working for large and start-up companies. Mitch holds project management and Six Sigma Green Belt certifications and has extensive global experience that includes two decades in the CMO/CDMO outsourcing industry. His achievements include multiple biopharmaceutical commercial launches for new and extension products.

Moderator: Karen Langhauser | Chief Content Director Pharma Manufacturing

Karen currently serves as Pharma Manufacturing's Chief Content Director. Formerly the Editor-in-Chief of Food Manufacturing magazine, Karen was particularly successful at eating all of the snacks that were mailed to her from food companies, as well as reaching readers through the magazine's digital platforms, launching the brand's first daily newsletter. She made the decision to trade food for drugs in 2013, when she joined Putman Media as the Digital Content Manager for Pharmaceutical Manufacturing.

Karen graduated with honors from Bucknell University, where she played Division 1 softball and occasionally did some schoolwork. Happily living in NJ's famed Asbury Park, Karen is a retired Garden State Rollergirl, known to the roller derby community as the "Predator-in-Chief."

As an editor with 20+ years experience in the B2B manufacturing space, Karen passionately believes that B2B content does not have to be boring and jargon-filled, and as such, has launched an ongoing mission to keep Pharma Manufacturing's editorial look, tone and content fresh and accessible.

Source:  Pharmamanufacturing.com