Understanding Risk Assessment of Proper Application

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.

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

Speaker Profile:
Louis Angelucci is a pharmaceutical professional and Certified Quality
Engineer with over 20 years of experience in Quality Assurance, Quality Control, Validation, consent decree remediation as well as cGMP Compliance in the Medical Device and Pharmaceutical industries. Lou has worked for several well know companies inclusive of Johnson & Johnson, Bristol-Meyer Squibb, Pfizer, Schering Plough and Merck.

Contact Detail:

Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

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