2009 Open Conference on Compendial Change

February 9-10, 2009
Baltimore, MD
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

The first quarter of 2009 will see the publication of a large number of proposed changes and new informational chapters in Pharmacopeial Forum.  Do not miss this opportunity to discuss these NEW chapters as they are released - with the experts!

The conference will be devoted to a discussion of the international regulatory climate with special emphasis on harmonized compendial chapters, and recently implemented chapters of the USP.  The conference will provide instruction and an opportunity for discussion of:

• The exploration of the continuum of the microbial control and test in the manufacture of sterile pharmaceutical products
• The determination of the inconsistencies in compendial, regulatory and industrial practices in microbial control (and the identification of how they could be made more consistent)
• The establishment of consensus positions whenever possible.

The afternoons of the conference will be devoted to discussion with compendial and regulatory experts on the following general topics:

Topic List (with publication issue in Pharmacopeial Forum)

• Aseptic Processing - USP <1211>, <1116> and the EU Annex 1 changes (PF 35(2) - March/Apr 2009)
• Harmonized Tests:
  • Sterility Tests (USP <71>) (PF 34(6) Nov/Dec 2008)
  • Harmonized Microbial Limits Chapters (<61>, <62>, and <1111>) (PF 34(6) Nov/Dec 2008)
• Revisions to Best Laboratory Practices <1117> (PF 35(2) - March/Apr 2009)
• New Informational Chapter on Microbial Identification (<1113>)  (PF 35(1) - Jan/Feb 2009)
• New Monographs

Speakers

• Jim Akers, Ph.D.   Chair USP MSA*, President, Akers, Kennedy and Associates (Invited)
• Dennis Guilfoyle, Ph.D.  USP MSA, US FDA
• Len Mestrandrea, Ph.D. USP MSA, Consultant
• David Porter, Ph.D. USP MSA, Vectech Consultants
• Scott Sutton, Ph.D.  USP MSA, Vectech Consultants
• Radha Tirumalai, Ph.D.  USP Staff - Liaison to MSA
  * USP Committee of Experts - Microbiology and Sterility Assurance

Who Should Attend

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

Registration

Conference registration is available online.

Exhibitors may register for this conference online.

Venue

Baltimore Marriott Waterfront
700 Aliceanna St.
Baltimore, MD 21202
   
More information on reservations will be provided upon conference registration (room rate will be kept under $179/night).
 

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 participants will:

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

• The learner will 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."

• The learner will 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.

• The learner will be able to discuss the proposed changes in clean room management and sterility assurance (USP chapters <1116> and <1211>) and compare to EU Annex 1 expectations.

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

Facilitator

Scott Sutton, Ph.D., PMF, Vectech, USP MSA

Conference Organizers

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

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