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Advanced Good Distribution Practice (GDP) Part III - Change control, subcontracting and outsourcing, contracts

Medicines - Europe

The Change Control chapter describes how an organization should deal with important changes. Change Control can relate to all areas covered by the quality control system. A proportionate and effective Change Control system should facilitate a systematic and documented approach and incorporates the principles of quality risk management.

Third-party suppliers of products and services must meet the organization's quality requirements and standards. It is essential that the processes, products and services provided do not adversely affect on the organisation's ability to consistently comply with its obligations.

Quality contractual agreements are essential in the communication between parties and ensure that tasks are correctly defined, agreed and controlled in order to avoid misunderstandings which could affect compliance with norms and regulations.


  • Change control theory
  • Change control practical exercise
  • Subcontracting and outsourcing
  • Supplier qualification and monitoring
  • Contractual agreements

For whom

  • Experienced Responsible Persons for Good Distribution Practice
  • Responsible Persons who wish to update and extend their Good Distribution Practice knowledge
  • Managers of a pharmaceutical wholesale company or those who plan to obtain a European pharmaceutical wholesale license
  • QA managers

knowledge of GDP essentials is highly recommended

Practical arrangements

  • The training will take 1/2 day (3-4 hours)
  • Note pages will be available in pdf format
  • Participants who require a training certificate can take a multiple choice quiz (10 items, 80% correct answers to qualify)
  • Maximum 6 participants

A discount is granted from the third participant of the same company.

Contact us if you want a tailor-made course or if you want the training to take place in your offices

Course details

Date and time



+32 476 41 51 35

€ 750.00 excluding VAT