Event Date/Time: Nov 12, 2008
Common Industry practice is not necessarily best practice or even good practice for some firms. We will review cases and examples of mis-applying limits calculations; worst case assumptions, analytical methods that lead to problems. This presentation and discussion of regulatory guidance and requirements and resulting common expectations will allow participants to outline a strong CV program and plan based on scientific rationale and pragmatic risk assessment. This plan forms the basis for establishing acceptance criteria, analytical and sampling approach and organizing the test plan, process groups and matrix approach; topics which will be covered in more depth in subsequent Modules.