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Date: 21st September, 2009

Location: Frankfurt, Germany

Summary:
Pharmaceutical - Seminar

PDA is organising a Discussion Forum with most distinguished Regulatory Speakers on implementing of Rapid Microbiology Methods (RMMs). As a result of our PDA Rapid Microbiology Methods Conference 2009 held in Berlin, and by request of the participants, practical questions and the view of regulators on them will be in the centre of the discussion. This important event focuses on the basic aspects of implementing Rapid Microbiology Methods in a GMP development, formulation and manufacturing environment. As pointed out during our Conference, scientific and regulatory guidance is often not readily available. This dilemma and specifically the need to discuss implementation aspects is acknowledged by the Regulators present and hence, a meeting focussed on such practical aspects and based on questions raised by participants was agreed on. The meeting will develop around questions put forward from participants on but not limited to the following topics:

• Scientific Advice
  
• Validation and Transition Issues
  
• Documentation and Use of Rapid Microbiology Methods: Regulatory Aspects and Issues
  
• The Variations Trauma for Rapid Microbiology Methods: Strategies for Implementation and Issues
  

Participants are encouraged to send in their specific questions or issues, to make sure, the Regulators can prepare for concise and to the point answers. There are no limitations to the topics, delegates might want to ask for in the context of RMMs. PDA guarantees anonymity and confidentiality, if case studies or other sensitive data is put forward to be discussed.

PDA Discussion Forum: Implementing Rapid Microbiology Methods