Microbiology Series 2012 – Part 1

• New year, old challenges!
  A discussion of how the acceptance of rapid microbiological methods (RMMs) continues to be hampered by misconceptions, misunderstandings and myths.
• Rapid micro methods and EMA’s post approval change management protocol
  A review of a relatively new process that the European Medicines Agency (EMA) launched that allows for the review and approval of RMM validation strategies before testing is initiated.
• Rapid sterility testing and the impact of recent changes to the US Code of Federal Regulations
  Recent changes in regulatory policy make it clear that RMMs for finished product sterility testing have a place in our industry, and it is the FDA that is leading the motivation for change.

About Dr. Michael J. Miller

Dr. Michael J. Miller is currently the President of Microbiology Consultants, LLC. For more than 23 years, he has held numerous R&D, manufacturing, quality, and consulting and business development leadership roles at Johnson & Johnson, Eli Lilly and Company, Bausch & Lomb, and Pharmaceutical Systems, Inc. Dr. Miller consults with multinational companies in providing technical, quality and regulatory solutions in support of RMMs, sterile and non-sterile pharmaceutical manufacturing, contamination control, isolator technology, validation and microbiological PAT.