This comprehensive course is designed to provide an intensive review of currently available rapid microbiological method (RMM) technologies, validation strategies, applications, regulatory expectations, financial justification models and implementation plans.The use of rapid methods for conventional pharmaceuticals, biotech and short shelf life products, including advanced therapeutic medicinal products (ATMP; gene and cell therapy) will be specifically integrated into the discussions.

Taught by one of the industry’s global leaders in rapid methods, the attendee will be immersed in discussions that will provide a meaningful and understandable roadmap for how to evaluate RMMs and employ them in their own laboratory and manufacturing areas.

Who Should Attend

Departments: Microbiology, Compliance, Engineering, Manufacturing, QA/QC, CMC Documentation, Regulatory Affairs, Research and Development, Validation, QC

Learning Objectives

• Discuss the benefits of alternative and RMM technologies as compared with classical microbiological methods
• Describe the scientific basis for a variety of technologies that may be qualified as alternative methods to classical microbiology procedures; explore case studies and actual workflows for dozens of commercially-available technologies
• Explain the regulatory environment, guidance, policies and expectations for validation, submissions and implementation from FDA, EMA, TGA, PMDA, ISO and WHO; understand when and how to change acceptance levels
• Develop business plans and return on investment justifications, follow an actual case study in significant cost savings and cost avoidances by implementing a RMM for environmental monitoring
• Apply industry best practices for validating these new technologies in order to demonstrate that the methods are acceptable for their intended use via IQ, OQ and PQ qualification strategies; understand the differences between PDA TR 33, USP <1223> chapter and Ph. Eur. Chapter 5.1.6
• Appreciate new guidance for rapid sterility testing of advanced therapeutic medicinal products (ATMP; gene and cell therapy) including compendial expectations and regulatory acceptance; justification for sample size allowances and the latest validation strategies