Quality Risk Management Techniques
Online Training Id: PQMS-002
Geographical Region: Global
Duration: 4 hrs
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.
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