An NSF International Company M13 - Process Validation Professional - Process Validation for Medical Devices – Planning and Conducting
PrintMedical Devices Training Module 13
£1910.00 excl VAT (20% discount available for additional delegates booking from the same company)
About this course
A highly interactive course. The first day starts you off with the requirements for process validation and looks at various guidance from the FDA/IMDRF/Harmonized standards and GAMP to extract the basic principles of process validation. Building on from the basic requirements we examine the techniques of understanding the product specification, integrating risk management activities and setting the course for the validation activity. From validation master planning to setting up the validation study, this is a course specifically aimed at professionals who need to get on and manage highly complex validations. We bring together the statistics, engineering study and regulatory science coupled with quality assurance principles in order to ensure that you can leave feeling in charge of your next validation project.
Who Should Attend
Any professional in a development, manufacturing engineering, quality assurance or supplier background where processes require validation. This course enables you to plan, implement and manage validation projects that are regulatory compliant. If you are a pharmaceutical quality professional you will find this course particularly interesting if you need to understand the differences between pharmaceutical and medical device process validation approaches.
