Risk-MaPP: Application of the New Risk-MaPP ISPE Baseline® Guide (E10)
| 5 June 0.6 CEUs 1.0 Industrial Hygiene CM Points Approval #: 08-955 |
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Working Agenda Current as of 14 April 2008 Download Working Agenda  PDF, 32 KB |
Grasp this unique opportunity to participate in interactive discussion with a gathering of industry experts from the USA and Europe who successfully applied the risk management principles set out in the new Risk-MaPP Baseline Guide and used the output from their work to convince regulators that they are capable of containing highly hazard compounds without the need to employ dedicated facilities.
Representatives from key regulatory agencies will present their perspective on use of risk-based techniques to support decision making associated with the handling of high hazard compounds.
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 and Europe are working on revisions to parts of their Good Manufacturing Practice (GMP) guidelines. The window of opportunity is temporarily open for you to reshape the industry’s view of risk, and influence the regulatory agencies toward a more scientifically-based approach.
The ISPE Risk-MaPP Baseline Guide is the result of a dedicated group of individuals, representing many disciplines within the pharmaceutical industry working together to show how the rational use of a science-based risk assessment process can be used to assess compounds, on a case-by-case basis, to support manufacturing strategies that allow for the use of multi-product facilities. Segregation by exception and not by loose association must be the intent.
How You Will Benefit
At the conclusion of this session, participants will be able to:
- Identify the differences between hazard, exposure and risk and how they are related;
- Analyze emerging regulatory issues worldwide that impact containment and Risk-MaPP;
- Recognize how regulatory agencies intend to apply the Risk-MaPP principles to their inspection strategies;
- Understand when and how to approach regulatory agencies to discuss risk assessments and sourcing strategies;
- Better understand how principles of the ISPE Risk-MaPP Guide can be used to apply a risk-based approach to sourcing products, and to manage risks associated with high hazard compounds; and
- Examine how some manufacturers already apply Risk-MaPP principles to source products.
Who Should Attend
Industry professionals from these disciplines: engineering, regulatory compliance, occupational toxicology, industrial hygiene, quality, manufacturing and supply chain, cleaning validation, and oral solid dosages
Communities of Practice (COPs)
Containment, Active Pharmaceutical Ingredients (API), Heating, Ventilation, and Air Conditioning (HVAC), Sterile Products Processing (SPP), Project Management (PM), and Oral Solid Dosages (OSD-In development)