GDP RP - Follow-up (English)

In the training 'GDP RP - Follow-up' we refresh your knowledge en deepen your understanding of Good Distribution Practice as Responsible Person. This training complements our successful GDP-RP training. How has the GDP Directive developed? What is the importance of risk management within a GDP quality system? How can we apply validation in practice? What are the consequences of serialisation for a wholesaler/distributor? What developments are there to prevent the falsification of medicines?

On request

This training will be given on request only. This means that a date will be scheduled in case of >5 enrollments.

Target Audience

• Responsible Persons and other managers, supervisors and staff members who are involved (in)directly in the storage, transportation and distribution activities of pharmaceutical products.
• Participants are expected to have some prior GDP knowledge and experience and if possible followed the GDP-RP training.
• HBO level

 

Programma

GDP and RP: developments and responsibilities
Recent development - points for attention

• International GDP Certificates
• Risk management of the logistics process
• Temperature control during transport
• Introduce serialisation in EU as of Feb. 2019
• Definitive use of Eudra GMDP-database for supplier and customer monitoring
• GDP fo active commodities

The (changing) role of RP

Case study regarding responsibilities

Validation and Qualification

Validation principles

Validation in practice

• Qualification of refrigerated storage
• Mapping of a Warehouse
• Software validation (GAMP 5)

Quality Risk Management (QRM)

• ICH Q9, Quality Risk Management tools
• Application QRM within GDP

Workshop

• Risk Analysis

Practical information

• Amount of participants: minimum 5, maximum 12
• Start time: 09:00 AM & End time: 05:00 PM
• Extensive lunch is included