ISO 13485:2016 – Chapter 6: Resource Management

Description:

The learning objectives for this program are to understand what ISO 13485 is, and what some of the key advantages to an ISO 13485 certification can provide. Also, to provide an in depth understanding of which policies, procedures and systems need to be put in place to be able to implement and maintain compliance with the 13485 standards. In module 6 we will discuss the provision of resources, human resources, infrastructure, work environment and contamination control.

Curriculum for this course:
Module 1: Introduction
Overview 45 secs
Course introduction 1 min 31 secs
CFR, ICH and The FDA 1 min 21 secs
Challenges facing the medical device industry 1 min 10 secs
Single user license 58 secs
Course objectives 1 min 09 secs
Module 6: Resource Management
Provision of resources 1 min 20 secs
Human resources – Training plan 1 min 30 secs
Human resources – Higher degree of competency 1 min 20 secs
Human resources – Awareness 1 min 45 secs
Infrastructure 1 min 52 secs
Infrastructure – Validation Master Plan (VMP) 1 min 09 secs
Validation Master Plan – Structure 1 min 16 secs
Validation Master Plan – GAMP®5 1 min 19 secs
Validation Master Plan – Example 1 min 38 secs
Qualification Vs Validation 1 min 42 secs
Three stages (IQ, OQ & PQ) 1 min 49 secs
Installation Qualification (IQ) 1 min 10 secs
Operation Qualification (OQ) 1 min 30 secs
Performance Qualification (OQ) 1 min 29 secs
Maintenance and Calibration 1 min 41 secs
Work environment and contamination control 1 min 05 secs
Pest control SOP 1 min 08 secs
Controlled Environment Rooms (CER’s) 1 min 20 secs
Cleaning procedure 1 min 06 secs
Conclusion
Final Assessment
Certification
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