Pharmaceutical manufacturing is a mix of art and science. A perfect example of this is small-scale process development and the up-scaling to commercial manufacturing. As a tightly regulated industry, the development and maintenance of controlled manufacturing processes requires you to have a clear understanding of key principles of pharmaceutical manufacturing including:
- Quality Assurance (QA)
- Good Manufacturing Practices (GMP)
- Good (Quality Control) Laboratory Practices (G(QC)LP)
- Manufacturing technologies
- Process optimisation and validation
Through this course you will develop a basic understanding of quality management, be able to describe the process conditions that impact quality for different dose forms and state process control and validation strategies for these dose forms.
“This course provided us with a myriad of insights, working solutions and informative documents as well as practical knowledge and tools that can be easily applied into the various GMP functions used at our facilities.
I found the course to be comprehensive, informative and thought-provoking. SeerPharma was extremely thorough, engaging and helpful with our questions.
I would highly recommend it!”
Director – Quality and Compliance (global pharmaceutical company)
- Quality Assurance of finished dose forms
- Requirements for GMP and G(QC)LP
- Starting materials and product supply
- Solid dose forms:
- Formulation of tablets, capsules…
- Steps in manufacturing
- Granulation technology
- Blending technology
- Particle size
- Blend Uniformity
- Coating technology
- Liquid dose forms:
- Formulation of solutions, suspensions, creams, ointments…
- Bulk manufacture
- Microbiological Control
- Various case studies of GMPs and finished dose forms from industry
This course is designed for people who work in process development, validation, production and quality roles that need to understand products and processes in order to make correct and effective decisions on manufacturing and quality related matters.
Format and Course Length:
The 2-day course involves a lively mix of case studies / workshops and intensive tutorial sessions. The delivery method is collaborative with a small group and facilitator, which has been shown to enhance learning and critical thinking skills of participants. You will receive copies of all presentation slides and a Certificate.
Call us or click here to e-mail us and register your interest.