GDP Forum
Objectives
Background
In the last few years the world of GDP has changed in scope and complexity and continues to evolve to meet new challenges with the continued aim of safeguarding public health. The Falsified Medicines Directive (2011/62/EU) was transposed into the laws and regulations of the EU Member States alongside the introduction of revised EU guidelines on Good Distribution Practice. Many other countries followed adopting these Guidelines or implementing very similar approaches.
Target Group
Question and Answers Session
Answers will be given by the expert speakers in a dedicated session and published in the members are of the GDP Association’s website (www.good-distribution-practice-group.org).
Programme
Performance beyond Compliance
- Benchmarks with sense
- When is a system or process robust?
- Easily understandable key figures
- Case studies
Brexit Implications
- Import/ export issues
- Drug shortage challenges
- Falsification
- Serialisation
- Co-operation of the agencies
GDP Challenges in Africa
- Background
- Evolution of GDP over the years
- Problems involved
- Steps taken to improve
Customer Master Data
- Definitions
- Parties involved
- Responsibilities and RP oversight
- Managing Customer Master Data
- Lifecycle Management
3 parallel Workshops:
1. Risk Management in GDP Warehousing
- Challenges and possible solutions
- Examples
2. When things go wrong – what can happen in the real World
- Experiences made in examining problems in the supply chain – and what to learn from them.
3. How to deal with suspected and confirmed falsified Medicines
- What is a suspected falsified medicine
- How to identify falsified medicine in your workplace
- How to approach the investigation of a suspected pack
- What should the end user do with the pack – who should manage communication with the end users
You will be able to attend TWO of these workshops. Please choose the ones you like to attend when you register.
Case Studies:
The Roche Quality Governance Model for Distribution to Direct Markets
- Selection, implementation, operation and decommissioning of partners
- Key Performance Indicators (KPIs)
- Compliance score card
The Switch from Air-freight to Sea-Freight
- Challenges and Benefits
- Examples
From external to internal Solutions - Insourcing of Warehousing and Logistics
- Implementation of own storage areas for minimum supply at the site
- Container and transport vehicle purchasing (refrigerated, warm, hazardous)
2 parallel Workshops:
1. Master Data and Serialisation
- Master Data for Serialisation
- Alerts Handling
- Exercises
2. Distribution of ATMPs
- Challenges when dealing with ATMP
- What information is needed to help service providers
- Examples
You will be able to attend ONE of these workshops. Please choose the one you like to attend when you register.
Costs
| ECA-Member*: | € 1590,- |
| Non ECA Member*: | € 1790,- |
| EU/GMP Inspectorates*: | € 895,- |
| APIC Member Discount*: | € 1690,- |
| GDP Association Member Discount*: | € 1590,- |
(All prices excl. VAT). Important notes on sales tax.
not available
not available
This course is part of the GMP Certification Programme "ECA Certified GDP Compliance Manager"
Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
Testimonials
