Compliance Seminars®

Good Distribution Practice
- A Practical Approach

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.


Course description:

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 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.

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.

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.

 

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Course facts

Course no:
5222
Industry:
Medicinal/Pharmaceutical industry; storage and distribution of pharmaceutical products including raw materials (excipients and APIs), intermediates and final dosage forms.

Level:
Basic / Intermediate
GMP region:
EU and US

Language:
English
Instructor:

Mr Robert J. Hayes

Date, location and venue:

This course is only offered in-house.
Click here for more info and inquiry form.


Time:
2 days