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PAT UPDATE RAPID MICROBIOLOGY

PAT UPDATE RAPID MICROBIOLOGY. Bryan S. Riley, Ph.D. Review Microbiologist CDER/OPS Advisory Committee for Pharmaceutical Science April 13, 2004. Rapid Microbiology and PAT. ACPS - PAT Subcommittee Meeting October 23, 2002 Rapid Microbiology Breakout Session. Rapid Microbiology Training.

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PAT UPDATE RAPID MICROBIOLOGY

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  1. PAT UPDATERAPID MICROBIOLOGY Bryan S. Riley, Ph.D. Review Microbiologist CDER/OPS Advisory Committee for Pharmaceutical Science April 13, 2004

  2. Rapid Microbiology and PAT • ACPS - PAT Subcommittee Meeting October 23, 2002 • Rapid Microbiology Breakout Session ACPS

  3. Rapid MicrobiologyTraining • July 2003 - Rockville, MD • CDER, ORA, CBER and CVM • Agenda • Overview of RMM Technologies • Two RMM Vendors • RMM Validation Experience ACPS

  4. Rapid Microbiology Team • PAT RMM Team Members • Bob Coleman, ORA/DFI (Team Leader) • Dennis Guilfoyle, ORA/NERL • Brenda Uratani, CDER/OC • Bryan Riley, CDER/OPS ACPS

  5. Rapid Microbiology Submissions • Pre-Submission Meeting with Applicant • Comparability Protocols • Product Release Testing • Water Testing • CBE-0 (Implementation) • Product Release Testing ACPS

  6. Rapid MicrobiologyInspection • RMM Team Meetings • Sept 2003 • Feb 2004 • Inspection (Feb 2004) ACPS

  7. Future of Rapid Microbiology • Traditional Microbiology Methods • Days (Weeks) • Current RMM Technology • Days or Hours • Future of RMM • In-Line, Real-Time Testing? ACPS

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