The provision of medicines and medical devices is a global business with active pharmaceutical ingredients, components and products being sourced using increasingly complex supply chains.
Recognising the limitations of regulatory oversight by individual countries, the US Government passed the Drug Supply Chain Security Act (DSCSA) as legislation requiring a national track-and-trace system for medicines and electronic tracing of production through the supply chain; enforced by the FDA from 01 May 2015. The EU has also enhanced their GDP requirements and these have been in place for some time.
These actions reinforce the need for all personnel in your organisation’s supply chain to understand their role and work to implement and maintain a robust and comprehensive quality system. The application of risk management principles within this system will help your organisation safeguard the quality and supply of product to your customers.
This course will provide you with a detailed understanding of the principles of responsible supply chain management and a framework for implementation and improvements. Specifically, you will learn the principles and practices of Quality and Risk Management Systems that you need to ensure the integrity of your supply chain, including:
- Management responsibility
- Regulatory and customer requirements: current and future
- Maintaining the cold chain
- Process control and validation
- Good documentation and record keeping practices
- Continual improvement
A selection of the following case studies, drawn from real life scenarios, will be used to demonstrate the application of Quality Risk Management to Supply Chain Management to you:
- Product contamination
- Management of 2nd tier suppliers
- Lack of formal contracts
- The use of brokers in the supply chain: raw material source of origin
- Temperature controlled transportation
- Change control
- Inconsistent analytical results
- When not all the links in the supply chain are known
- Reuse and potential infection of medical devices
This course is for you if you have a level of responsibility for the quality and/or integrity of your organisation’s supply chain, specifically in relation to the procurement, distribution and logistics of sourcing and supplying pharmaceuticals, pharmaceutical ingredients and medical devices.
Format and Course Length:
The 1-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 in a public session or having this course delivered on-site.