Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigation 2018

Topics

• Determine alternatives or options to the proposed solution
• How to propose a solution to the problem related to the deviation, change control, risk assessment or validation study
• Validate the solution, assess product impact to the market
• Analyze costs, benefits, impacts, and risks of the proposed solution
• Determine impact to the patient, system or firm as a result of your findings

Who should Attend

• Regulatory Affairs/Regulatory Compliance Directors, Managers,and Specialists
• Quality Assurance/Quality Control Directors, Managers,and Specialists
• Engineering/Development Directors, Managers, and Specialists