Risk Management Masterclass [2024] | Certification Course

Be an expert in ISO 14971 (RM) and ISO 13485 (QMS). Create risk assessment docs like DFMEA, HAZOP, HACCP from scratch

Created by: Anil Sharma Kandel
Industrial and Manufacturing Engineer

What Will I Learn?

• Become an expert in creating Risk Management documents from scratch, such as PFMEA, DFMEA, HAZOP, HACCP for any enterprise.
• Learn-depth on how to perform Risk Assessment, Risk Evaluation, Risk Measurement, Risk Control and Benefit-Risk Analysis!
• In-depth understanding of Regulatory standards for GMP environment such as ISO 14791:2019, EU 2017/745 MDR, 21 CFR 820, SOR/98-282, ISO13485 and ISO 22000
• Be proficient in what Food and Drug Administration (FDA) auditors are looking for while doing Quality audits in medical device and food industry,
• Learn why CAPA, Non conformances, IQ/OQ/PQ, complaint handling process are crucial for medical device industry
• Learn in-depth about Quality Management system (QMS) regulations from different countries around the world
• How Risk management Activities is essential in creating a good manufacturing practice (GMP) environment.

Requirements

• No prerequisite required. Course progresses from basic to advanced level with easy to grasp content and real world examples.

Target audience

• Professionals looking to be promoted or looking to get into medical device, pharmaceutical industry and food industry