A robust quality system that meets the requirements of pharmaceutical regulators is an essential element of every good pharmaceutical manufacturing operation. This course will introduce participants to the essential features of a US Good Manufacturing Practice (GMP)-compliant quality management system as well as covering recent developments in pharmaceutical regulation. The duties of personnel in the production, quality control and quality assurance departments will be explained, together with requirements for GMP-compliant documentation and records. The expectations of regulators regarding the qualifications, experience and on-going training/development of personnel will also be covered.
Special emphasis will be given to the relatively recent topic of pharmaceutical data integrity, including controls required over quality-critical electronic data systems. Participants will also be introduced to the concept and application of quality risk management in a GMP environment.
The material used in the training course will be based on exercises as well as regional and international case studies. Participants will frequently work in pairs with one another as well as in larger teams.
This course is designed for production and quality control professionals in the pharmaceutical manufacturing industry. It will be particularly beneficial for individuals responsible for compliance or quality assurance such as quality auditors, regulatory affairs professionals, production auditors, regulators, training and production managers, as well as anyone interested in effective GMP compliance tools and techniques. Professionals working with finished pharmaceuticals, combination products or devices will also gain insight on how to better structure their respective quality systems.
Dr Mark Powell
Dr Mark Powell is a UK-based provider of auditing, training and consultancy services to the pharmaceutical industry. He set up his own business in 2013, having worked as both Analytical Manager and Scientific Manager for a pharmaceutical manufacturer.
He is accredited as a training provider by Cogent Skills, the UK’s strategic body for training in the science industries. A Fellow of the Royal Society of Chemistry, he is an experienced trainer in the area of pharmaceutical quality systems. He has written and delivered many pharmaceutical training courses and specializes in QC laboratory auditing and pharmaceutical data integrity. He is regularly asked to speak at scientific meetings and is the author of over 30 scientific papers and conference presentations.
Dr Powell is currently Honorary Treasurer of the Royal Society of Chemistry’s Analytical Division and leads a RSC working group on continuing professional development.