Quality Risk Management Techniques

Online Training Id: PQMS-002

Geographical Region: Global

Level: Basic

Duration: 4 hrs 

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This guideline provides principles & examples of tools of quality risk management that can be applied to different aspects of pharmaceutical quality.

These aspects include development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances, drug (medicinal) products, biological and biotechnological products.

Learning Objectives:

This course will provide an introduction to the skills and competencies required, to evaluate the impact of out of specification and process deviation by Quality Risk assessment. The candidate will learn how to asses and mitigate risk by using techniques such as Risk cause analysis and failure mode Effect analysis.

The course comes in two parts:

Part 1 covers. The Principals of Quality Risk management and the Quality Risk Management Process.

Part 2 covers Risk Management Methodology  and the use of QRM in Industrial and Regulatory processes.











John DR Jolley - FR Pharm S, FCQI CQP is a co-founder of Pharma Consult Global, a Pharmaceutical Consultancy providing technical consultancy and training European countries, Middle East, South Africa and the USA and involving International Pharmaceutical Experts from around the world.  He is a pharmacist who has held positions in Clinical Research, Product Registration, Pharmaceutical Manufacturing, Quality Assurance, and General Management.  He was Technical Director for Boehringer Ingelheim UK for 15 years before working in Technical consultancy. He is a practicing Qualified Person (QP) for pharmaceutical manufacturing, Distribution and Clinical Research organizations, and  is  an  Industry  representative  on  the  EMA  advisory  committees  for GMP/GCP.  John  has  a  degree  in  Pharmacy  and  has  been  awarded  fellowships  with  the  Royal Pharmaceutical Society and the Chartered Quality Institute.

John Dr Jolley  FR PHARM S, FCQI CQP

GBP $120.00