This conference is your opportunity to interact with regulators and thought leaders in frank and open discussion on issues of immediate relevance to the manufacturing environment.

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Conference Description

The Fall Forum is the annual PMF meeting devoted to topics of recent research and publication into the hot topics of the day.  This year, it is all about current thinking and progress in validation and qualification in the microbiology lab. 

PMF Conferences are known for bringing current speakers on advanced, technical subjects to the industry.  This workshop is no exception.  Each speaker has time allotted for an interactive discussion on the listed topic, so come prepared with questions. 

The Fall Forum is the annual PMF meeting devoted to topics of recent research and publication into the hot topics of the day.  This PMF conference will get into some exciting, current thinking and progress in validation and qualification in the microbiology lab.    

Topic List

• Method Suitability Studies for Microbial Recovery.
• Validation of a Rapid Mycoplasma Test method
• Validation of an Environmental Monitoring program
• Validation of a Microbial Identification System - The Database
• Fitness of Use of a Rapid LAL Method for Biotechnology
• Avoiding the Pitfalls of Validating Pharmaceutical Water System
• Rapid Microbiological Methods
• Qualification of Equipment in the Microbiology Lab

Speakers

• William Collentro, Water Consulting Specialists
• Claudio Denoya, Ph.D. Research Fellow, Pfizer
• John Duguid, Staff Scientist II, Genzyme
• Robert Ferer, President, The Ferer Group
• Sara Polson Staff Scientist, Accugenix, Inc. 
• Scott Sutton, Ph.D. Principal, Microbiology Network, Inc.

Check out the video! 

Who Should Attend

• Microbiology Laboratory supervisors and Microbiologists responsible for testing and release of Pharmaceutical, Parenteral and Medical Device products. 
• Regulatory and Compliance Personnel responsible for auditing of manufacturing facilities and QA and Contract Microbiology Laboratories. 
   

Registration:

Conference registration is available online.

Note:  10% Early Registration Discount ($1615 USD) for all
registrations received by August 30, 2010.

Venue:

Woodcliff Hotel and Spa
199 Woodcliff Drive
Fairport, NY   14450  
 

CEU & Learning Objectives

The participants in this conference will receive 1.3 CEU IACET-certified credit (13 contact  hours)  upon successful completion of the conference. 

The participants are expected to actively participate in discussion and questions for the conference - the unique strength of this conference is the opportunity to discuss the science behind the regulations.  

The participants will:

• Be able to explain the critical aspects of validation in the microbiology lab.

• Critically review potential contributions of technology to design, validation and maintenance of an environmental monitoring program.

• Understand draft regulations from ISO, EMEA and USA that is relevant to design of a compliant environmental monitoring program.

• Be able to evaluate the significance of contamination in the controlled environment.

• Understand the requirement and methodology for validation of cleaning efficacy in the program.

Facilitator:

Scott Sutton, Microbiology Network

Conference Organizers

• The Pharmaceutical Microbiology Forum
• High Peaks Associates (conference coordinators)

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