Pharmaceutical and Quality Assurance Training Course

Course Description – Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

This two-day pharmaceutical training course will explain the principles of dosage form design and how poor decisions at the design stage result in unstable processes and problem products. Product design should begin with identification of critical process and material parameters, but all too often this stage of the development is rushed and product yield and quality are compromised. Rectifying these problems retrospectively can be difficult and expensive. "Right the first time" is the key to success.

The quality assurance course will also identify the key elements of a successful products, along with some novel techniques which can be applied both as development and as troubleshooting tools. By achieving proper integration based on sound scientific principles, many development and production problems can be avoided. The course includes case studies of tablet formulation development and a detailed step-by-step analysis of all elements of the tablet manufacturing process.

Upon completing the course, all participants will have a comprehensive understanding of the principles of formulation development and how they can be used to understand and troubleshoot manufacturing issues and problems, and improve productivity.

Who Should Attend

The quality assurance course will benefit personnel working in formulation and product development, manufacturing, product support, and regulatory affairs. This course has been created to assist those involved in the formulation design of tablets and capsules including identifying and troubleshooting design and production issues that may arise. Attendees are encouraged to bring specific problems for the group to consider.

The course will be especially useful for those involved in:

›           Pre-formulation and Formulation development

›           Tablet and capsule product and process development

›           Tablet and capsule production troubleshooting support staff

›           Process Development who wish to extend their understanding of the relationship between formulation and process, and how formulations are selected in the real world

›           Regulatory and quality areas who need to improved understanding of tablet and capsule manufacturing technologies

Michael Gamlen, Ph.D.

Michael Gamlen, Ph.D.

Specialties: Manufacturing

Dr. Michael Gamlen is Managing Director of Gamlen Tableting Ltd., a Nottingham (UK)-based tableting consultancy. He is in the inventor of the Gamlen Tablet Press – the world's only bench top, instrumented laboratory tablet press. With over 35 years of experience in tablet formulation development and manufacture; Dr. Gamlen has successfully developed hundreds of tablet formulations.

For 15 years, Dr. Gamlen served as Head of Tablet Development for the Wellcome Foundation. Since then, he has worked as a tableting consultant and trainer – specializing in product development, formulation, tablet and process development studies.

For many years, Dr. Gamlen has taught highly rated professional tableting courses. He continually updates course content with the latest guidance and extracts of up-to-the minute scientific papers and provides course attendees with access to an extensive bibliography of relevant papers.

Dr. Gamlen holds a First Class Honours degree in Pharmacy, specializing in Pharmaceutical Engineering. He studied for a Ph.D. at Nottingham University.