2010 PMF Open Conference on Compendial Advances - Participating in Change

January 25-26, 2010

Baltimore, MD

Open Conference | Register Now | Schedule | Speakers | Exhibitor/Sponsors

This conference is your opportunity to interact with international regulators in frank and open discussion on issues of immediate relevance to the microbiology lab in a small, personalized format.  This type of conference offers a unique small, personalized format for instruction and discussion.

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


Conference Description
The format and purpose of this meeting is somewhat unique. The compendia play a large role in the activities of the QC laboratory; our input (into their discussions) is of enormous benefit to both their deliberations and the quality of the documents that result. The PMF is providing an opportunity for the membership to meet in small groups with representatives from regulatory agencies to discuss issues relating to laboratory operations, GMP and the microbiological quality of finished products.

The conference will begin with a keynote address by Susan de Mars, J.D., Chief Counsel, USP on "The Importance of Participation to Improvement of the USP".  The morning will continue with a Plenary Session consisting of presentations from regulatory experts providing background information throughout the first morning.  That afternoon the conference will split into smaller discussion groups moderated and led by compendial experts. 

The second morning will continue with more presentations and small discussion groups in the afternoon. 

Come and pose your questions to those involved in writing the compendial chapters!  This is an unparalleled opportunity to benchmark your practices not only against current regulatory expectations, but also against other companies in the industry. 

The schedule is available here.

Presentation topics will include:

• Clean room control and Filtration - USP <1211>, <1116>
• Microbial Identification (NEW USP <1113>)
• Microbiological Best Lab Practices (USP <1117>)  (NEW DRAFT)
• Non-sterile Manufacture Control (NEW PROPOSAL)
• Water Microbiology (USP <1231>)
• Reference chapters - USP <1>, <41>, <645>
• Harmonized Referee Tests
  • Microbial Limits - <61>, <62>, <1111>
  • Sterility Tests - <71>
  • Bacterial Endotoxin Tests - <85>

Facilitators and Speakers

• Susan de Mars, JD - Chief Counsel, USP
• David Hussong, Ph.D. - Associate Director, FDA/CDER
• Len Mestrandrea, Ph.D.
• David Porter, Ph.D. - Vectech Pharmaceutical Consultants, Past Director, USP
• Donald Singer - GlaxoSmithKline; USP MSA
• TC Soli, Ph.D. - Solipharma Solutions; USP Purified Water
• Scott Sutton, Ph.D. - Vectech Pharmaceutical Consultants, USP MSA
• Radhakrishna Timuralai, Ph.D. - USP Staff Liaison to USP MSA

Biographies for the speakers are available.

A PDF version of the conference brochure is available.

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.

Venue

Baltimore Marriott Inner Harbor at Camden Yards
110 S. Eutaw Street
Baltimore, Maryland
1-800-236-2427

CEU & Learning Objectives

The participants in this conference will receive 1.4 CEU IACET-certified credit (14 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 learners will:

• understand the international harmonization process, its strengths and it weaknesses for the microbiology community.

• be able to describe the difference between "specified organisms" as detailed in the compendial Microbial Limits tests, and the requirement detailed in 21 CFR 211 that non-sterile dosage forms be "free of objectionable organisms."

• be able to distinguish between laboratory practices that are designed to encourage reproducible lab studies, and those that may contribute to uncontrolled variability in the results.

• know the requirements of USP water and how to determine compliance in laboratory or manufacturing grade systems.

• be able to discuss the proposed changes in clean room management and sterility assurance (USP chapters <1116> and <1211>).

• be able to evaluate a potential microbial identification technology against the criteria described in the proposed USP chapter <1113> Microbial Identification.

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

Open Conference | Register Now | Schedule | Speakers | Exhibitor/Sponsors