What you need to Know about Pharmaceutical Quality Management Systems
Online Training Id: PQMS-001
Geographical Region: All
Duration: 2 hrs
This module provides the latest update ( includes amendment to EU GMP Guide– Feb 2014)to assist in implantation of PQMS in all aspects of the provision and use medicine to ensure consistency of quality in accordance with the best practice standards guidelines for ICH and PIC.
Topics included are:
The Principals for provisions for quality management systems.
Risk management approach to ensuring quality compliance.
Commissioning, Qualification and Validation – Which one to use.
Problem resolution to achieve best operating practice in PQMS
This course is designed for personnel working in all sectors of health care, and will provide all participants with the additional knowledge to further their careers. Upon completion of this course, attendees will:
Be able to understand and apply Quality Management concepts to decision making in a managerial role in the management of health care provision
To understand and appreciate the principals of Risk based assessment and how to apply corrective and Preventive action Planning and Root cause analysis to resolving quality solutions.
The course provides guidance on how to apply the principals of QMS to cGMPs; GCP and GDP apply to their role and responsibilities.
Understand procedures and equipment design that impact on achieving quality solutions.
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