Education Sessions

ISPE’s Risk-MaPP Baseline® Guide: Its Impact and Application (102)

27 October 13.30-17.00 Track: Regulatory

ISPE CEUs: 0.2

agenda(PDF Current as of 2 October 2008)

The need for dedicated facilities for the manufacture of certain classes of compound has been the subject of much debate in recent years. The rationale for separating certain compounds has not always been clear and regulators in the USA, Canada, and Europe are working on revisions to parts of their Good Manufacturing Practice (GMP) guidelines that would, if implemented, dictate groups of compounds for which dedication would be mandated.

This session will provide an abbreviated introduction to Risk-MaPP. Representatives from key regulatory agencies will present their perspective on use of riskbased techniques for making decisions associated with the handling of highly hazardous compounds.

Currently there are two new guides under development, an ISPE Risk-MaPP Baseline Guide and a Science and Risk-Based Cleaning Guide. This session will highlight the status of these two projects.

How You Will Benefit

At the end of this session, participants will be able to:

  • Explain the purpose of Risk-MaPP and how it fits into a quality systems strategy
  • Understand how regulatory agencies are applying the Risk-MaPP principles to their inspection strategies
  • Analyze emerging regulatory issues worldwide that impact containment and Risk-MaPP
  • Participate in a regulatory round-table/panel discussion on the issue of dedicated facilities

Who Should Attend

Quality, regulatory compliance, manufacturing, including contract manufacturers, engineering, operations, environmental health and safety, occupational toxicology, and cleaning validation

ISPE Communities of Practice (COPs)

Active Pharmaceutical Ingredients (API), Containment, Disposables, Heating, Ventilating, and Air Conditioning (HVAC), Oral Solid Dosage (OSD), Project Management (PM), and Sterile Products Processing (SPP)

Regulators Invited

FDA, USA; AFSSAPS, France; ANVISA, Brazil; Health Canada, Canada; Medical Products Agency, Sweden; and MHLW, Japan

 

Session Leader

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Annual Meeting Sponsors