ISO 13485:2016

ISO 13485:2016 – Chapter 6: Resource Management

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.

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CEU Credits: 0.1
Course Code: ELM-804
Duration: 45 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0

Curriculum for this course

Overview
Course introduction
CFR, ICH and The FDA
Challenges facing the medical device industry
Single user license
Course objectives
Provision of resources
Human resources – Training plan
Human resources – Higher degree of competency
Human resources – Awareness
Infrastructure
Infrastructure – Validation Master Plan (VMP)
Validation Master Plan – Structure
Validation Master Plan – GAMP®5
Validation Master Plan – Example
Qualification Vs Validation
Three stages (IQ, OQ & PQ)
Installation Qualification (IQ)
Operation Qualification (OQ)
Performance Qualification (OQ)
Maintenance and Calibration
Work environment and contamination control
Pest control SOP
Controlled Environment Rooms (CER’s)
Cleaning procedure

Conclusion

Final Assessment

Certification

Author

Don Rackham

Associate Director QA Asterias Biosciences

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