TBA
Day Course
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Risk Management of APIs Manufacture
Lecturer: Ms. Karen Ginsbury
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TBA
Day Course
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Audits of APIs Manufacturers
Lecturer: Ms. Karen Ginsbury
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17/03/2009
Day Course
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Supply Chain Risk Management – an Interactive Workshop
Professional management: Mr. David Inbar
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TBA
Day Course
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Risk Management for Medical Devices
Lecturer: Mr. Gadi Shtepel
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Mandatory requirements for Risk Management in the Design, Development and Manufacturing of Medical Devices are defined in ISO 13485:2003 and ISO 14971:2007 standards. The ISO 14971:2007 was also recognized by the FDA as a Consensus Standard for Risk Management. |
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11/02/2009
Day Course
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Risk Management Strategy Planning
Lecturer: Dr. Malcolm Ross, Switzerland
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Although risk management in the industry is not new, recently the Regulatory Authorities are making it a formal requirement through such initiatives as ICH Q9 [Quality Risk Management] and the FDA’s Risk Evaluation and Mitigation Strategy for new drugs. |
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