Overview:
Risk Assessment is a fundamental expectation in the regulated industries of pharmaceutical and medical devices. Performing risk assessments can be interpretive and needs to be well thought out in order to rationalize and substantiate conclusions drawn. With proper use it is a good model and will save in terms of dollars and schedule when properly applied. Risk Assessment is a regulatory expectation that should be taught and emphasized at all levels of a going concern.

Why should you Attend: The reason for attending would be to gain a perspective and understanding of the proper application of risk assessment. The proper practice of Risk Assessment is the current expectation of regulatory authorities. Many regulatory related documents and guidance now speak of the application of risk throughout a process inclusive of qualification and validation. The proper application of risk has become fundamental and an accepted part of base business.

Areas Covered in the Session:

• The regulatory derivations of Risk Assessment
• The expectations of risk
• How to properly analyze and determine risk
• The fundamental equations necessary for risk assessment
• The tools of Risk Assessment and their definitions
• How to defend and assign proper risk

Who Will Benefit:

• QA specialist
• Managers
• Engineers
• Operators

Speaker Profile

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