This one-day course will help in gaining an understanding of the fundamental principles of pharmaceutical GMP and how compliance affects product quality.
This course is intended to provide learners with an introduction to the fundamental principles of pharmaceutical GMP (PIC/S), the regulatory environment and product realization through market authorization, manufacturing, and lifecycle requirements.
Practical activities throughout the day will give you opportunity to illustrate your acquired knowledge of pharmaceutical GMP.
How will I benefit?
This course will help you to:
- Gain fundamental knowledge of pharmaceutical GMP and how it links regulation to the regulator(s) and related Good Practices (GxP)
- Identify the key requirements of pharmaceutical GMP
- Gain a fundamental understanding of GMP compliance on product quality
Who should attend?
The course is ideal for anyone involved in a pharmaceutical organization, including research and development (R&D), onsite dispensary/warehousing, production, packaging and labelling, quality control/quality assurance; or if you’re in a role within an organization that supplies such organizations with services or materials (raw materials, Active Pharmaceutical Ingredient (API), filters, packaging materials or consumables).
What will I learn?
Upon completion of this course, you’ll be able to:
- Describe what a medicine is
- Describe what pharmaceutical GMP is
- Identify types of GxP’s and the relationship to medicine life-cycle
- Define key requirements of pharmaceutical GMP
- Appreciate fundamental GMP principles
- Recognize the role of the GMP regulator in a global market
- Identify the quality management systems within GMP
What's included?
- Detailed course notes and lunch are provided
- On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate
Course Resources
