1. GDP Conference on 05.10.2017 in Düsseldorf

Regulatory Requirements

The regulatory requirements for Good Distribution Practice of medicines are a consistent continuation of the rules applied during the manufacturing of medicines for Good Manufacturing Practice. This represents another step towards the quality assurance of medicines and starting materials throughout the entire logistics chain, including distribution to pharmacies.

Why GDP?

Good Distribution Practice is increasingly coming to the forefront. Supply chains are becoming more complex due to various factors, such as outsourcing. Therefore, transportation and distribution are gaining ever greater importance. The entire supply chain, from the production of active and auxiliary substances to the marketing of the finished product, must be precisely described and controllable. GMP only leads to high-quality products if the last link in the chain, transportation and distribution, also contributes to this.

Controlling the entire supply chain is also of utmost importance in the context of preventing counterfeit medicines.

The Conference

Exchange with other companies and regulatory authorities is an important component of the conference. Through presentations, workshops, and Q&A sessions, various issues are discussed, allowing you to compare your own implementation of GDP requirements with others, and also to gain useful new ideas. Another important aspect of the conference is the opportunity to expand your network. The conference thus provides an ideal platform for authorities and industry.

Goals
•   You will receive a GDP update.
•   You will get an overview of all new developments.
•   You will learn from case studies.
•   You will exchange ideas with colleagues from other companies and with regulatory representatives.
•   You will understand expectations and issues related to GDP inspections and audits.

Contents

- GDP Update: Regulatory requirements, Rico Schulze, State Directorate Saxony, Chemnitz
- Workshops on Audits and Inspections: Audit preparation, experiences from inspections
- Auditing logistics service providers: Case studies, experiences, Christian Specht, EIPL European Institute for Pharma Logistics GmbH, Korntal-Münchingen
- Challenges for transporters: Trends, Stefan Thömmes, trans-o-flex Schnell-Lieferdienst GmbH, Weinheim
- Practical GDP Workshops: What does GDP mean for a small wholesale?, Practical implementation of Change Control, Deviations, and CAPA, Risk Management, Temperature Monitoring, Management Review
- GDP for wholesale: Challenges, Jan Beyersdorf, Sanacorp Pharmahandel GmbH, Saarbrücken
- Data Integrity in Temperature Mapping: Data integrity in temperature monitoring of storage rooms, Joachim Gau, ELPRO-BUCHS AG, CH Buchs

Leadership:
» Pharmacist Reinhard Schnettler, PTS Training Service

Topic Area:
GDP Good Distribution Practice

Target Group:  
Experts

PTS Code:  
2944

Participant Fee:  
870 EUR

Education Points:  
125

Date:
05.10.2017

Start:
09:30 AM

End:
approx. 4:45 PM