Industry field:
Medicinal/Pharmaceutical industry; storage and distribution of pharmaceutical products including raw materials (excipients and APIs), intermediates and final dosage forms.
Course description:
This course is designed specifically for staff working in wholesale and distribution of medicines. It will assist them in understanding and applying Good Distribution Practice principles to practical workplace situations.
The development of the rules and guidelines of GDP will be discussed with the delegates, who will then go on to investigate the implications, potential risks to product safety and the control systems in place within their organization. By relating these findings back to the organization’s quality system, the delegates discover how quality is an integral part of their business.
The course includes a number of workshops and case studies to allow the delegates to put their learning into practice.
Course outline:
- Regulations and guidance
- The Quality System
- Risk management
- The responsible person
- Self inspection
- The inspection process
- Facility management
- Stock management
- Temperature control and monitoring
- Transport – including Cold Chain
- Counterfeit medicinal products
Learning objectives:
The objectives of the course are that delegates will understand the regulatory requirements and constraints facing wholesalers and distributors of medicinal products. The attendees will become familiar with the relevant sections and clauses of the EU Rules, as well as being able to develop their organization’s process and identify the controls necessary to ensure compliance with GMP/GDP regulations and guidelines and, at the same time, operate effectively in a competitive market.
Who should attend:
The course is aimed at anyone who has responsibility for finished pharmaceutical products, intermediates or raw materials during storage and distribution – including transportation. This will include staff working in Quality, Operations, Transportation etc.
The course includes a significant number of practical exercises, case-studies and workshops to allow delegates to investigate real situations and develop practical solutions.
Delegates will be encouraged to share personal experiences and solutions to the various challenges faced in everyday work.
To request further information on this course or to reserve a place (with no obligation) please contact us using the details below:
PO Box 3255,
Littlehampton,
BN17 9AD
Tel: 01903 730 622
e-mail: debra.stanfield@seerpharma.co.uk
