Wednesday, 17 October 2018
9:00
Welcome
9:15
Introduction to RMMs, Applications, Implementation Strategies, Opportunities
Growth-based RMMs; Scientific Principles, Applications and Case Studies
10:30
Coffee Break
11:00
Regulatory Policies and Expectations: FDA, EMA, TGA, PMDA, ISO and WHO
12:30
Lunch Break
13:30
Cellular-component Based RMMs; Scientific Principles, Applications and Case Studies
Viability-based RMMs; Scientific Principles, Applications and Case Studies
15:30
Coffee Break
16:00
Spectroscopic-based RMMs; Scientific Principles, Applications and Case Studies
Genetic and Gene Amplification-based RMMs Part 1; Scientific Principles, Applications and Case Studies
18:00
End of Day 1
Thursday, 18 October 2018
9:00
Genetic and Gene Amplification-based RMMs Part 2; Scientific Principles, Applications and Case Studies
10:30
Coffee Break
11:00
MEM-based RMMs; The Future of Alternative Technologies
Validation of RMMs Part 1; Due Diligence Activities, Vendor Expectations, IQ, OQ and PQ Strategies, Validation Acceptance Criteria, Use of Statistics
12:30
Lunch Break
13:30
Validation of RMMs Part 2; Equivalence, Method Suitability, Comparison of PDA TR33, USP <1223> and Ph. Eur. 5.1.6
A Case Study on Conducting Economic Assessments and Return-on-Investment (ROI) Calculations
Review of ATMP (gene and cell therapy) expectations for rapid sterility testing according to the revised Ph. Eur. Chapter 2.6.27
15:00
Coffee Break
15:30
References, On-line Resources and Final Remarks
16:30
End of Training Course