2008 PMF Workshop on Microbial Validation

June 9-10, 2008
Presented by the Pharmaceutical Microbiology Forum

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

This conference is your opportunity to learn the most complete and up-to-date approaches to validation concerns in the microbiology arena.

The Pharmaceutical Microbiology Forum has offered a training conference in different aspects of validation since our very first conference in the spring of 2003.  This year the planning committee took a fresh approach to the questions based on input from both the PMFList and from those attending conferences and expressing an opinion on desirable topics.

 Four main areas of concern were apparent in the general subject of validation:

1. Method Suitability Studies  (Scott Sutton, Ph.D.)

   • Types of Studies (USP <1227>)

   • Relevant Statistical Considerations

   • Practical Examples (Sterility Test, Antimicrobial Efficacy Test, Bioburden, Media Growth Promotion)
     

2. Environmental Monitoring (Robert Ferer)

   • Establishing sample sites

   • Establishing and maintaining alert and action levels

   • Use in ongoing Contamination Control Program
     

3. Microbiology Lab Equipment (Courtland Imel)

   • Terminology

   • Qualification vs Verification

   • Lab Equipment calibration, standardization, qualification and how to determine which is required (with pointers on how to meet regulatory expectations for each)
     

4. Water Systems  (TC Soli, Ph.D.)

   • Basics of water treatment for pharma and lab use

   • Validation issues - purchase, installation and SOPs, monitoring, operational concerns

   • Issues peculiar to lab-scale water systems

   • Packaged water an option?

PMF has assembled recognized experts in these areas to present half-day sessions on each.  At the end of the workshop, the participants will have a well-balanced appreciation for the major validation concerns of a QC microbiology lab.

Learning Objectives

Workshop attendees will be able to:

1. Understand and be able to implement a comprehensive validation plan for the laboratory
2. Contribute to the validation master plan for a manufacturing facility.
3. Understand the regulations and standards that govern different aspects of validation and equipment qualification relevant to the microbiology function.
4. Understand the importance of complete and thorough microbial deviation reports for regulatory inspections purposes

Who Should Attend

The meeting will be of particular interest to pharmaceutical microbiologists and microbiology laboratory managers, contract laboratory microbiologists and managers, pharmaceutical manufacturers, and individuals concerned with the regulatory aspects of microbial control.

Program

The workshop will be divided into four sessions.  Registration is for the entire two day workshop, no partial registrations are available

Venue

Doubletree Hotel Philadelphia
237 South Broad Street
Philadelphia, PA  USA 

Reservations may be made by calling 800-222-8733.  Please mention  “Validation” to receive the group rate.  This rate is effective until May 26, 2008.

Workshop Facilitator:

  Scott Sutton, Ph.D. - President, PMF

Workshop Organizers

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

Workshop Home Page | Register | Speakers | Exhibitors