Alternative Microbiological Methods

March 16, 2015 – March 17, 2015

USP’s interest in microbiology arises from its role in developing public quality standards that help ensure the consistency of drug substances, drug products, excipients, food ingredients and dietary supplements.

This workshop will focus on new and revised information on the validation of alternative microbiological methods, validation of alternative methods to antibiotic microbial assays and the current status of USP’s work on rapid/modern microbiological methods.

Participants are encouraged to discuss and offer input and perspectives throughout the workshop.

Agenda

Featured Speakers

  • James Akers, Ph.D., Chair, USP Microbiology Expert Committee
  • Nobuyasu Yamaguchi, Ph.D., University of Osaka, Japan
  • David Roesti, Ph.D., Novartis, Switzerland
  • Edwin van den Heuvel, Ph.D., Professor of Medical Statistics, de Eindhoven
    University of Technology (TU/e) in Eindhoven, Netherlands
  • Stephen Wicks, Ph.D., European Directorate for the Quality of Medicines (EDQM),
    France

Topics

  • Revisions to General Chapter <1223> Validation of Alternative Microbiological Methods:
    • Validation Criteria
    • Equivalence Approaches for Alternative Qualitative and Quantitative  Microbiological Methods
    • Statistical Tools
  • New Chapter <1223.1> Validation of Alternative Methods to Antibiotic Microbial Assays
    • Validation Criteria/Bridging Studies for Simple and Complex Antibiotics
    • Data Evaluation/Statistical Tools
  • Proposed Draft Chapter on Modern/Rapid Sterility Tests
    • Criteria used for selection of proposed method(s)
    • Proof of Concept Studies
    • Collaborative Laboratory Studies
    • Current Status

Who Should Participate

  • Professionals in the pharmaceutical, biotechnology and compounding fields
  • Analytical development scientists
  • QA/QC specialists
  • Microbiology laboratory supervisors
  • Microbiologists responsible for testing of pharmaceuticals, biologics, compounded products, dietary supplements and food ingredients 
  • Regulatory and compliance authorities

Registration Information

Regular Price Information

Advance registration for this event will close on Wednesday, March 11, 2015. Once closed, on-site registration will be available at the USP Meetings Center.

Packages Price Savings
Academia/Association Participant $500  
Industry Participant $900  
Group* - Academia/Association Participant $400 $100 w/ group rate
Group* - Industry Participant $800 $100 w/ group rate
Government Rate $150  

*Group rate is for three (3) or more participants from the same company. To receive the group rate, all registrants must register on the same online registration form. On page 2 of the online form, be sure to select at the end Add Another Registrant.

If you are not attending but registering one (1) or more persons, at the beginning of the online form on page 1, select I am registering other people but not myself.

If you have already completed registering three (3) or more people and would like to add two (2) or fewer additional attendees, click on the REGISTER button and use the Promo Code "Group" at the end of the online form.

For additional assistance, contact a Meetings Services representative at (301) 816-8130 during business hours of 8:30am-5pm EST, Monday – Friday, or at conferences@usp.org.

Other Registration Information

Registration fee includes full two-day program, meeting materials, continental breakfast and lunch, and a networking reception. Contact conferences@usp.org for details.

USP–U.S.
12601 Twinbrook Parkway
Rockville, MD 20852
United States
Phone: +1-301-816-8130
See map: Google Maps

Local Area Information

Hotels

If you require overnight accommodations, we welcome you to take advantage of the USP corporate rate at the hotel below. Please note that the USP corporate rate is subject to availability.

Hilton Washington DC/Rockville Hotel & Executive Conference Center*
1750 Rockville Pike, Rockville, MD 20852
Metro Station: Twinbrook (Red Line)

2015 USP Corporate Rates (effective January 1 - June 30, 2015)

  • $195 per night (+taxes). Rate includes wired and wireless internet access.
  • $205 per night (+taxes). Rate includes daily breakfast buffet in the hotel restaurant and wired and wireless internet access.
  • Reserve a room online

*USP will not provide shuttle service from the Hilton Hotel, as it is within walking distance to USP.

Airports

Three major airports serve the Washington, DC, area:

Transportation