An in-depth look at the EU GDP Guidelines and their application in areas of transport. Topics covered during the training will highlight deficiencies identified during regulatory inspections of wholesale distributors involved in the transport of temperature-sensitive medicinal products. This will include ambient medicinal products as they are also temperature-sensitive products.
Day 2 will focus on the practical application of how to perform risk assessments and perform qualification activities to meet regulatory expectation, reduce product waste/rejection and ensure quality products are distributed to patients.
Premises and equipment
Management of subcontractors
Qualification of temperature-controlled sea shipments
Passive shipping systems qualification
Qualification of temperature-controlled vehicles
Thermostability and Temperature excursions management
Digital supply chain
Your role in the supply chain is critical to ensure patient safety
A quality culture needs to be led and seen from top down
Compliance is a driver for business and continuous improvement
The course was packed with lots of really useful information and insights. The trainers perspectives demonstrated their extensive experience and they took the time to discuss course attendees particular challenges in detail.
The event was well organized and the trainers
very competent, demonstrating hands-on knowledge both from the industry itself as well as having worked at a medicines agency (MHRA). Very trustworthy. The attendees also shared experience from „real life“, I learned a lot from that too
I have found the event interesting, exciting and
stimulating. Knowledgeable and experienced trainers will guide you through the best distribution practices for temperature-controlled Pharma products, willing to advise also on specific challenges you may encounter within your company. Beneficial is also experience sharing with other participants.