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?
Certificate after successful completion.
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
Notes:
- This training content will be delivered via BSI’s Connected Learning Live Platform as a virtual classroom with the BSI tutor. This will provide the delegate with the flexibility of attending it from the convenience of home or office, without travelling to BSI facility. A stable internet connection, headset with USB connection, a quiet and suitable work area. In advance of the training a ‘testing room’ will be provided for delegates to confirm their hardware works and that they can fully participate in the training.
- Examination will be conducted online via an e-assessment platform 'Questionmark'. Invigilation will be done through delegate’s webcam and microphone.
Please Note: This training fee is applicable only for residents of India and the Indian subcontinent.
