Understanding Risk Assessment of Proper Application

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.

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.

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