Back to: FDA Compounding Quality Center of Excellence Annual Conference 2025
About:
Discover the essential facility design elements to control environmental parameters, such as temperature, humidity and pressure. This presentation will be followed by a panel of outsourcing facilities to share challenges and considerations on setting up their facility and quality systems.
Presenter:
Mitch Garber
President
MG Aseptic and Quality Assurance Consulting
Mitch Garber is an aseptic manufacturing/sterility assurance subject matter expert. He is currently the President of MG Aseptic and Quality Assurance Consulting. Prior to starting his own consulting company, he was Head of Product Facility Build at 2seventybio where he led the construction, operational start up and validation of a new clinical cell and gene therapy facility. He obtained his B.S. in Pharmacy from the University of Sciences in Philadelphia He has over 40 years of professional experience in quality, aseptic manufacturing, GMP auditing, regulatory compliance, validation, and sterile product/process development of pharmaceutical, cell therapy and biological products.