Why Should You Attend:

Both the U.S. FDA and the EU's MDD require product risk management as part of virtually all regulatory compliance efforts. Companies must be proactive in reducing product risk while increasing user benefits. Companies are still not developing the required tools nor using them in all regulated / CGMP activities. When used, companies have not provided the documentation to allay investigators' / auditors' concerns. Existing risk documents are not used to their full potential .

Areas Covered in the Seminar:

• Key requirements of ISO 14971 and ICH Q9.


• Suggested formats to meet both FDA and MDD requirements.


• Expected sources of information for evaluation and inclusion.


• How to compile.


• When to involve the team.


• How to complete, document and control as a 'living' document.


• An often neglected safety feature.


• Effectiveness -- Determining and Monitoring.


• Realizing real cost savings

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