CEU Credits: 0.1
Course Code: ELM-808
Duration: 45 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Curriculum for this course
Overview
45 secs
Course Introduction
1 min 31 secs
Course Objectives
1 min 21 secs
CFR, ICH and The FDA
1 min 10 secs
Challenges Facing the Medical Device Industry
58 secs
Single User License
1 min 09 secs
Control of Nonconforming Product
1 min 21 secs
General – Product Specification
1 min 21 secs
General – SOP Nonconforming Materials
50 secs
Actions in Response to Nonconforming Product Detected Before Delivery
1 min 30 secs
Actions in Response to Nonconforming Product Detected Before Delivery – 100% Inspection
1 min 09 secs
Actions in Response to Nonconforming Product Detected After Delivery
1 min 10 secs
Actions in Response to Nonconforming Product Detected After Delivery – Minor Misprint
1 min 50 secs
Actions in Response to Nonconforming Product Detected After Delivery – Major Misprint
55 secs
Rework
1 min 09 secs
Analysis of Data
1 min 10 secs
Ultimate Goal – QMS is Effective
59 secs
Pareto Analysis
1 min 30 secs
Improvement
1 min 15 secs
General – Corrective Action / Preventative Action
51 secs
Corrective Action
1 min 14 secs
Corrective Action – Two Factors
58 secs
Corrective Action – Severity
1 min 41 secs
Corrective Action – Initiation
56 secs
Corrective Action – Team & Description
1 min 09 secs
Corrective Action – Plan
56 secs
Corrective Action – Investigation Phase
1 min 30 secs
Corrective Action – Plan
1 min 28 secs
Corrective Action – Evidence
49 secs
Corrective Action – Effectiveness Check
1 min 20 secs
Preventative Action
56 secs
Annexes
1 min 29 secs
Conclusion
Final Assessment
Certification
