HIGH PEAKS Associates Conference Planning Services Rochester, NY


2008 PMF Fall Forum

Recent Advances in Environmental Monitoring

October 13-14, 2008
Rochester, NY (Airport Code: ROC)
Presented by the PMF

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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CLICK HERE to register online, or call us at 888-844-8561 (toll-free in US)

Conference Description

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

This PMF conference will get into some exciting, current thinking and progress in environmental monitoring and facility control.  The purpose of this meeting is to provide a forum for the sharing of questions, answers and information on current topics affecting the industrial microbiologist for the Microbiology Laboratory. One of major concerns in the microbiology function is the identification of relevant guidance for the unique product category. 

Topic List

  • ISO 14644 series revisions
  • The Effective Environmental Monitoring Program
  • Revisions to USP <1116> Microbiological Control and Monitoring Environments Used for the Manufacture of Healthcare Products
  • The Paperless EM Program
  • Control Strategies for Fungal Contamination in Cleanrooms
  • Isolation and Characterization of Bacteria Capable of Tolerating the Extreme Conditions of Clean Room Environments
  • Materials of Construction Based on Recovery Data for Cleaning Validation

Speakers

  • Carol Bartnett, Steris Corp.
  • Michael Cable, Argo Therapeutics  
  • Anne Marie Dixon, Cleanroom Management Associates
  • Richard Forsyth, Merck & Co., Inc  
  • Aaron Hubbell, Eli Lilly 
  • Scott Sutton, Vectech Pharmaceutical Consultants
  • Kasthruri Venkateswaran, JPL

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.
Early bird registration discount available until September 12, 2008.

Exhibitors may register for this conference online.

Venue:

Woodcliff Resort Woodcliff Hotel and Spa
199 Woodcliff Drive
Fairport, NY   14450  

Reservations may be made by calling 800-365-3065. 
Please mention “Fall Forum”  room block to receive the group rate of $139/night.  This rate will be in effect until Monday, September 29, 2008.
 

CEU & Learning Objectives

The participants in this conference will receive 1.2 CEU IACET-certified credit (12.3 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 environmental monitoring in the controlled environment.

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

  • Understand craft 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, Vectech Pharmaceutical Consultants


Conference Organizers

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


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For more information
888-844-8561 (toll-free)
(585) 594-3336
High Peaks Associates
150 Parkway Dr.
North Chili, NY 14514