Events
Good Distribution Practices (advanced course) – QA / Responsible Person

About the session

This advanced course will provide a thorough view on legal requirements for Good Distribution Practices and will focus on Quality Assurance and the role of the GDP Responsible Person in Belgium and The Netherlands.

The course will highlight the importance of GDP in ensuring the safety of pharmaceutical products during transport and storage and how it is an essential part of the healthcare supply chain.

Compliance with GDP requirements demonstrates that organisations are capable of delivering good quality products as intended by the pharmaceutical manufacturer.

The course is intended for Quality Assurance profiles working in warehousing or distribution. Or for persons who would like to become RP or for RPs who wish to refresh their knowledge of GDP.

This interactive training will be held in English. The presentation slides will be provided. Upon passing the test, a certificate will be provided.

Speaker

April Van De Mieroop – Director Q-support – GDP expert

Program

9:00 – Welcome (coffee & pastries)
9:30 – Course start
12.00 – Lunch
12:45 – Course restart
16:30 – Q&A
16:45 – Test
17:00 – Networking (drinks)

Price

878.90 € (excl. VAT)

Location

Fosbury & Sons Alfons – Coworking Brussel
Alfons Gossetlaan 40
1702 Groot-Bijgaarden

Topics covered by the training:

1. Introduction to GDP
2. EU guideline 2013/C 343/01
3. BE and NL legislation governing medicinal products
4. Quality Management
   • Management of outsourced activities, including technical agreements
   • Management review
   • Quality Risk Management
   • Change Control
   • Deviation Management
   • Documentation
   • Self-inspection
5. The Responsible Person / Personnel
6. Other: tips and tricks for compliant and pragmatic QMS, what’s we’ve learned from inspections, GDP for veterinary products, GDP for active pharmaceutical ingredients…
7. Warehouse operations
8. Qualification of suppliers and customers
9. Handling of complaints, returns, falsified products (incl Regulation 2016/161), recalls and returns
10. Transportation, brokers