Overview
This course is designed for operational personnel (key operators, supervisors and managers) who have a key role in ensuring the quality of product during production operations. QA and QC staff will also benefit from this course.
“A desired goal of the PAT framework is to design and develop well understood processes that will consistently ensure a predefined quality at the end of the manufacturing process. Such procedures would be consistent with the basic tenet of quality by design and could reduce risks to quality and regulatory concerns while improving efficiency.
Quality cannot be inspected into the product, it should be built-in or should be by design.”
PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance
FDA Guidance for Industry, September 2004
Participants will develop skills in analysing processes to establish whether or not the key parameters of a complex process are in control and capable of meeting specifications on a reliable and repeatable basis.
Key Subject Areas
- Flowcharting
- Variation
- Common cause
- Special cause
- Process capability
- Run charts (control charts)
- Simple problem-solving – cause and effect analysis
- Process improvement – including risk assessment and change control
Course Outcomes
On completion of the course, participants will be able to:
- Define the factors that must be controlled to ensure processes are reliable
- Understand the types of variation and their main components
- Understand how special and common cause variations affect processes
- Evaluate the stability and capability of processes using SPC
- Apply problem-solving techniques to everyday issues
- Identify opportunities and apply process improvement techniques
- Relate process control to the requirements of GMP
Duration
2 days
Course Format
The course is designed to be intensive and interactive to achieve maximum learning experience. It is conducted in a workshop setting with theory lectures interspersed with practical exercises. Emphasis is on active participation so numbers are restricted to approximately 12 participants.
Presenters
SeerPharma will lead the course and facilitate the group activities.
Course Materials
Each delegate will receive a copy of course notes and other relevant material.
A certificate is presented to each delegate on completion of the course.
Further Training
We offer a range of extensions to this introductory course including such topics as:
- Advanced statistical techniques
- Introduction to Design of Experiments (DoE)
- Advanced DoE
To request further information on this course or to reserve a place (with no obligation) please contact us using the details below:
PO Box 3255,
Littlehampton,
BN17 9AD
Tel: 01903 730 622
e-mail: debra.stanfield@seerpharma.co.uk
