This conference offers you a unique possibility to evaluate the
new developments in RMM systems to extend the experiences in validation as well as
implementation of these systems in pharmaceutical industry. Furthermore you will learn more about the
expectations of authorities and developments in regulatory requirements. Amongst this, experts from laboratory and industry will give an insight view in the routine use of RMM.
Microbial contamination poses enormous risks to pharmaceuticals and their consumers. To minimize the quality and financial risk, pharmaceutical and biopharmaceutical manufacturers collect thousands of samples for bioburden or sterility testing a year. The classic culture methods are often laborious and require long incubation times. In the field of some biopharmaceuticals, Advanced Therapy Medicinal Products and other modern products, it is often not possible to wait 7 or more days for a result. RMMs provide the ability to reduce time and costs for microbial detection and increase the safety level of the products.
In the meantime several new systems for the detection of microbial contaminants and new identification systems are available at the market or in validation. The regulatory authorities like FDA, EDQM or MHRA assist the implementation of RMMs e.g. with the revision of the related guidelines or pharmacopoeias.
This conference is of interest to professionals in Quality, Microbiology and Validation from
- Pharmaceuticals and Biopharmaceutical Companies
- Contract Service and Research Laboratories
- Government Agencies
- Cell Culture Collections