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:
Louis Angelucciis 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. This work experience was acquired either as a direct employee or as a contracting consultant while employed at Foster Wheeler and Aker Kvaerner. As a consultant Lou has worked at various project locations both domestically and overseas.
Lou is a member of the IVT board of Directors and has been a contributing speaker to IVT since the organization’s early beginnings. He has published numerous articles on the subjects of Validation and compliance and has been a speaker to industry groups such as ISPE, IDE, PDA and ASQ.
Lou is currently employed by Validant a Quality, Regulatory and Engineering consulting firm with expertise in biotechnology, pharmaceutical and medical device industries. Lou is a Quality Systems Consultant specializing in Validation and Quality System Consent Decree administration and remediation.