Given the necessity of scaling manufacturing of existing products and developing more specialised, patient-centric drugs, the pharmaceutical industry is expanding into new markets. This market shift highlights the requirement to set up new, owned manufacturing sites or set up new contract manufacturing relationships. Therefore, the industry must ensure in parallel that individuals are upskilled to the GMP principles – it is paramount now more than ever.
This course is intended to provide you 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, so that the understandings can be utilized in the workplace on completion of the course.
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 is included title ?
- Includes refreshments, lunch and delegate manual, training course notes
- Loan copy of the standard (to be returned after the course)
Contact us
If you have any enquiries, let us know how can we help you.
Call: +91 80815 80815
Email us: info.in@bsigroup.com