He has developed extensive return on investment (ROI) models for rapid micro methods and will work with your senior management and finance groups to gain approval for RMM implementation. Miller provides an in-depth understanding of FDA and EMEA regulatory expectations for RMM validation and implementation, and can act as your liaison when meeting with regulatory agencies and competent authorities.
This applies not only to what should be tested and when, but also to the methods that should be used.
State-of-the-art presentations from authority speakers, as well as industrial and academic experts in the field of microbiological detection and identification and mycoplasmology with particular focus on the current methodologies their implementation and validation will provide an in-depth overview.
The scientific progress in the field of cellular and molecular biotechnology led to a fast development of biopharmaceuticals, tissue engineered applications and advanced therapy medicinal products (ATMPs).
The development of a meaningful strategy for the implementation of rapid microbiological methods requires a certain level of knowledge, skills and competencies on the subject, including the scientific, regulatory and business expectations when assessing and validating RMM technologies.
We can provide in-house, world-class professional training and consulting by a world-class technology leader and subject matter expert on RMMs.