Overview:
Are you trying to interpret and understand more precisely what good distribution practice means?
It could be that you’re new to the company or role. You could work for a supplier and want to learn and appreciate what good distribution practice means for you and your customers.
The Good Distribution Practice (GDP) training is a foundation or refresher course useful for individuals who need to understand what GDP means for the pharmaceutical manufacturer and subsequently their suppliers.
Organisations who store or transport pharmaceutical products need to understand and comply with GDP to ensure the safety and efficacy of pharmaceutical products throughout their shelf life and demonstrate commitment in providing a quality service for the delivery of pharmaceutical products in an ever increasing complex supply chain.
Content:
Investigate a review of the industry regulations
What is the scope of good distribution practice?
Directive 2001/83/EC and EU Guidelines on Good Distribution of Medicinal Products for Human Use 2013/C343/01
The Falsified Medicines Directive
Consider a number of subject areas relating to GDP including:
Essential quality management system elements
Good storage practices
Temperature mapping
Use of quality risk management
Equipment qualification and validation
Good transportation practices
Managing outsourced activities
Use case studies to explore the causes and implications of deviation from GDP