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: support@compliance4All.com