Course Brochure – London GDP Academy Sept 2018CERTIFICATED GDP TRAINING FOR PHARMACEUTICAL AND LIFE SCIENCE PRODUCTS
In the international world of transporting and distributing temperature-sensitive pharmaceutical and life science products by air cargo, compliance with Good Distribution Practice (GDP) regulation is mandatory. Revised EU guidance and other international rules also make it clear that all those involved in processing and handling these sensitive commodities must be properly trained and is an essential part of any UKMHRA/HPRA WDA authorisation.
IAG Cargo, through its Constant Climate service, is one of the worlds leading airline carriers of pharmaceutical and life science products and has invested heavily in facilities, processes and systems to meet GDP requirements, gaining UKMHRA approved status for its Heathrow facility. Exelsius Ltd has provided GDP Certificated training programme to IAG Cargo staff for over 4 years and has also trained over 2000external students internationally through in-house training courses.
Now in a unique collaboration, IAG Cargo and Exelsius have formed the Good Distribution Practice Academy and are able to offer this training to pharmaceutical manufacturers, logistic service providers, ground handlers and all others involved in the logistics process.
This course allows you an exclusive opportunity to combine classroom training with a ‘live’ visit to the airport airside area. See the handling processes used by IAG Cargo for its Constant Climate product and meet the operational team handling pharmaceutical and life science shipments across the globe to Good Distribution Practice standards.
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Course content includes:
- An examination of the latest global GDP regulations such as EU 343/01, including:
- Chapter 1 – Quality Management
- Chapter 2 – Personnel
- Chapter 3 – Premises & Equipment
- Chapter 4 – Documentation
- Chapter 5 – Operations
- Chapter 7 – Outsourced Activities
- Chapter 8 – Audits and Self Inspections
- Chapter 9 – Transportation
- Mapping a typical supply chain and examining critical control points
- Temperature control solutions – Active and Passive
- Quality Management Systems and audits
- Temperature Monitoring technology
- Service Level (Quality) Agreements and SOP’s
- Understanding and using CAPA in the logistics process
- Examining the application of IATA Temperature Control Regulations/Chapter 17 including correct use of the Healthcare label
- Understanding the requirements of the latest UK MHRA directives that require providers to hold a WDA licence
- The role of the Responsible Person in pharmaceutical logistics
How you will benefit from attending:
- Gain a detailed understanding of the world of international healthcare logistics
- Understand the application of Good Distribution Practice guidelines
- Experience an airport operational environment and witness airside procedures for IAG Constant Climate services
- Understand the essentials of Good Temperature Management and how to use Active and Passive transportation solutions
- Learn how to create and use SOP’s in your working environment
- Understand how to mitigate risk in the temperature-sensitive supply chain
- Learn how to choose and manage your outsourced suppliers
- Understand the role of audits in the Quality Management process
Return the form with your remittance at least 14 days in advance to receive confirmation of your course place and joining information.
This course is also available on an exclusive-company basis that will maximize your team’s effectiveness.
Please contact GDPAcademy@exelsiusglobal.com or call +44 1420 520498 for further details