CEU Credits: 0.1
Course Code: ELM-807
Duration: 45 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Curriculum for this course
Overview
Course Introduction
Course Objectives
CFR, ICH and The FDA
Challenges Facing the Medical Device Industry
Single User License
General Introduction
ISO Systems
Monitoring and Measurement
Feedback – Identify, Define, Document & Implement
Feedback – Methods
Complaint Handling
Complaint Handling – Incident
Complaint Handling – Process
Complaint Handling – Difficult to Manage
Complaint Handling – A Common Mistake
Reporting to Regulatory Authorities
Reporting to Regulatory Authorities – Adverse Events
Reporting to Regulatory Authorities – USA Reporting Timelines
Reporting to Regulatory Authorities – EU Reporting Timelines
Reporting to Regulatory Authorities – Canada Reporting Timelines
Reporting to Regulatory Authorities – Reporting Formats - Part 1
Reporting to Regulatory Authorities – Reporting Formats - Part 2
Reporting to Regulatory Authorities – Conclusion
Internal Audit – Effectiveness of Quality System
Internal Audit – Two Different Approaches
Internal Audit – Auditors and Lead Auditors
Internal Audit – Table of Regulations
Internal Audit – Findings
Monitoring and Measuring for Processes – Introduction
Monitoring and Measuring for Processes – KPI’s
Monitoring and Measuring for Processes – Corrective and Preventative Actions
Monitoring and Measuring for Processes – Other Factors
Monitoring and Measuring of Product - Introduction
Monitoring and Measuring of Product - Product Conformity
Monitoring and Measuring of Product – Tracking & Trending
Monitoring and Measuring of Product – Out of Control
Conclusion
Final Assessment
Certification