We will approach the roles of a Risk Analysis:

  • Focus: Systems Validation and Equipment Qualification;
  • What are the bases for carrying out a Risk Analysis;
  • What needs to be validated;
  • Establish the test acceptance criteria;
  • Define essential rules for the execution and application of Risk Analysis.

16/04/2020 at 14 PM

Graduated in Administration and Computer Science. Participated in the elaboration of ANVISA’s Computerized Systems Validation Guideline. ISPE authorized speaker for GAMP5 training, Mario has 20 years of experience and has participated in large-scale projects for companies such as Novo Nordisk, Shire, AstraZeneca, Pfizer, among others