Sterility Assurance Applied to Stem Cell Therapies

The complexity of modern medicines and their potential to do harm if manufactured inappropriately makes the need for quality assurance appear obvious. This was not always the case. Improvements in the safety and quality of medicines have nearly always been made as a corrective action to tragic events. 
 

Cell therapies and regenerative medicines require a high degree of informed control in order to ensure that their quality are maintained batch after batch. Official guidance in the United States and Europe must be combined with a current working knowledge of best practices. Such knowledge will enable innovators to build production systems with confidence. This webinar examines the implications of Good Manufactiring Practice legislation and guidance and the role of Quality Assurance in the generation of safe and effective cell-based therapeutics. 

 

Attend this webinar to learn:

  • Key aspects of cell therapy production and regulation
  • Sterility assurance applied to cell therapies
  • Control strategy for processes
  • Roles and relationships of the QA and the persons responsible for releasing goods from quarantine and into the market
  • Roles and activities of the QC department
     

Date: TBD. June 11th, 12th, or 13th of 2019.
 

Register by clicking the linkhttps://www.eventbrite.com/e/sterility-assurance-applied-to-cell-therapies-tickets-57645193325
 

Fee: $750. Register at least two weeks in advance for a 25% discount.

Speaker

Gilberto Dalmaso, PhD

Global Life Science Scientific Officer

Gilberto Dalmaso has over 25 years’ experience in pharmaceutical microbiology and sterility assurance, primarily with GlaxoSmithKline (GSK).  In 2003, his laboratory gained the distinction of obtaining the world’s first rapid microbial PAT approval from the US FDA. Today Gilberto is the Global Life Science Scientific Officer for Particle Measuring Systems, serves on the European PDA Committee, is a reporter to numerous symposia on the microbiology and Pharma in Europe, Asia and United States, and is an ISO 9001 and HACCP quality system auditor.