The control of microorganisms in our manufacturing processes and environments is one of the most important tasks in ensuring products are safe and effective. This is true for conventional pharmaceuticals, biotech products, compounding pharmacy drugs, gene and cell therapy products and radiopharmaceuticals. However, conventional microbiology methods are antiquated and do not support the need for faster, accurate and reproducible results. Therefore, the modern laboratory should develop innovative approaches for the detection, quantification and identification of microorganisms using alternative and rapid microbiological methods (RMM).
This comprehensive training course is designed to provide an intensive review of currently available RMM technologies, validation strategies, applications for use, global regulatory views and validation expectations, financial justification models, and technology identification and implementation plans.