ISO 14971: 2012 Awareness Training Program

Virtual classes schedule

13th - 14th Feb 2021: Awareness Program on Risk Management according to ISO 14971:2019 Standard I Duration: 02 Days

WHAT IS ISO 14971: 2012

Implementation of Risk Management is a one of the primary requirements while demonstrating the compliance to regulatory requirements and conformance to Quality Management system requirements to ISO 13485 Standard for Medical Device and In-vitro Diagnostic device manufacturers.

While analyzing the reasons for the product failures, most of the time it leads to inadequacy in understanding and implementation of risk management in the organization. This training is to create awareness of requirements and to have better understanding.

YOUR BENEFITS

• To have better planning and framework of risk management
• To demonstrate compliance to regulations
• To have structured approach while implementation
• To learn the overview of risk management activities
• To ensure product development with desired quality and safety standards
• Integration of risk management into an existing Quality Management System 

COURSE CONTENT / OUTLINE

•  Introduction to ISO 14971:2019 
•  Links to regulatory requirements 
•  Understanding pf ISO 14971:2019 standard and implementation 
•  General requirements for risk management system 
•  Risk analysis 
•  Risk evaluation 
•  Evaluation of overall residual risk 
•  Risk management review 
•  Production and post-production activities 
•  Application of risk management in QMS 
•  Exercise 

WHO SHOULD ATTEND?

• Product Risk Managers
• Quality Assurance
• Regulatory Affairs
• Research & Development
• Project Managers
• Operations Managers
• Manufacturing Managers
• Engineers

TRAINING DURATION

02 Days

PREREQUISITES

No prerequisite. 

PARTNER INSTITUTE INFO (IF ANY)

Nil

EXAM DETAILS (DURATION, PATTERN)

Participants will be assessed through a 50 marks written examination (open book) at the end of the course. Minimum passing % criteria: 70%.

CERTIFICATION

Participants who score 70% and above in the written examination will be issued a TÜV SÜD South Asia’s course completion certificate. Unsuccessful candidates will be issued a certificate of attendance.