Complete understanding of RCA and CAPA

All the learning Areas:

o    Regulatory Expectations for Investigations

o    What is RCA and Typical Problems

o    Investigation Process Overview

o    Skills and Tools of an Effective Investigator

o    (Re) Introduction to Root Cause Analysis (RCA)

• Principles of root cause analysis
• Why root cause analysis is difficult
• Methodology of root cause analysis

STEP 1 - Problem Definition

• How to ensure that the right problem is being worked on
• Tools and filters for priority setting
• Developing a clear and sufficient problem statement (includes practice)

STEP 2 - Understanding the Process

• How every problem is a process failure
• How diagrams can set boundaries and define interrelationships
• Using flowcharts to drill down into the right part of the process (includes practice)

STEP 3 - Identifying Possible Causes

• Multiple ways to identify possible causes
• Options for selecting or eliminating causes
• Logic trees as a cause and effect diagram and other tools for investigations

o    Defining the Deviation

o    Identifying Root Cause

o    Corrective and Preventive Actions (CAPA)

• What is the CAPA System
• Definition and regulatory interpretation
• Identifying and writing of corrective actions
• Abuses of the CAPA system
• Discuss robustness and effectiveness review

o    Management of the Investigation

o    Members of the Investigation Team

o    Consulting Case Study Practice - Incident/Events

o    Case Study Practice

o    Interactive Exercises and Discussions.

Complete understanding of RCA and CAPA

 

How to Register and Maintain Various Types of Combination Products in the USA and EU

Any understanding of the regulatory aspect concerning combination products in the EU is incomplete without a reference to the compromise it reached in September 2016 through its two major legislative organs, the European Commission and the European Council. Relating to medical devices and invitro diagnostic (IVD) devices; this compromise, reached as many as four years after a deal was made, is a regulatory landmark.

It empowers the EMA to now assess and authorize high risk combination devices, such as implants. Formulated to replace the existing EU legislation on medical devices and in-vitro diagnostics, this update brings in greater uniformity and consistency in the assessment and approval process of high risk combination devices across the EU.

Combination Products in the USA and EU