This course is established to provide industrial support through competent regulatory training to industry, user and other authority for achieving requirements of Medical Device Act (Act 737) and Medical Device Regulation 2012 (MDR 2012).

The training provides: • Familiarize with the latest FDA guidelines and interpretations of product/process validation. • Recognize how Validation Master Plans help the planning process. • Differentiate between qualification, verification and validation. • Identify if (and when) validations are required. • Determine what activities must be completed prior to conducting a validation (confirming) event. • Learn how to conduct and document a validation event. • Understand what to do when things go wrong (What if's!). • Use peer feedback to learn about your own planned or completed validation programs including specific issues and questions.