David Abraham, Quality Resource Solutions Associates, UK
Heike Gottschalg, Boehringer Ingelheim, Germany
Alfred Hunt, Hunt Pharma Solutions, Ireland
Savvas Koulouridas, Fagron BV, Netherlands
Dr Daniel Müller, GMP/GDP Inspector, Germany
Robert Müller, Boehringer Ingelheim, Germany
This Live Online Training provides practical guidance to bring and keep your organisation in compliance with the GDP regulations.
The globalisation of the pharmaceutical supply chain has created new challenges for the manufacture and supply of medicinal products in various markets, resulting in reduced control and increased security risk to the products.
The EU-GDP Guidelines have been extensively revised to take into account the changing nature of the globalised supply chain. The requirements have been effective since 2013. These requirements highlight the need for an effective quality management system supported by risk assessment and appropriate controls.
This two-day Live Online Training has been designed to bring you up-to-date with the current regulatory expectations and standards for Good Distribution Practice (GDP) and to provide you with tools and guidance to help you with identifying the gaps in your quality systems and planning and implementing the actions required.
GDP Compliance Managers and Responsible Persons from companies involved in the distribution and supply of medicinal products.
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical- information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Welcome and Introduction
The (new) GDP Guideline: What was it all about?
- Background to development and revision of the EU GDP Guidelines
- Overview of structure and Content
- What is the impact on industry and other stakeholders?
Quality Management System (QMS)
- What is a QMS and why do we need it?
- What does an effective QMS look like?
- How to develop and implement an effective QMS Operations
- Qualification of suppliers and customers
- Receipt, storage and return of medicinal products
- Deviation and Complaint Management in a wholesaler facility
- How to conduct a gap analysis, develop plans and implement the new requirements
Questions & Answers Session I
GDP Inspection Findings and what to learn from them
- Findings and their Ratings
- Examples from manufacturers, wholesalers, storage facilities and transport deviations
- Competency requirements for GDP personnel
- Overview of the role and responsibilities of the Responsible Person
- Necessary documentation
- Training matrix and managing continuous training
Questions & Answers Session II
Premises & Equipment
- What is a must for medicinal products
- How to plan and implement facility improvement ensuring compliance with the current requirements
- Key requirements for transportation of medicines
- How to develop and implement a GDP-compliant and cost effective transportation network.
Contracts in the Global Supply Chain
- International laws and systems – how they work and fit together
- Jurisdictions and conflict of law provisions
- Contract law, Technical/ Quality Agreement, Supply Agreement
- 3PL Providers: two bilateral agreements or one tripartite agreement?
- When things go wrong
Questions & Answers Session III
- What is an outsourced activity?
- How to set priorities to audit, approve and manage Service Providers
- How to develop and manage contracts and agreements
Case Study for a successful Implementation Approach
- How we approached the new requirements
- Challenges and best practice
Questions & Answers Session IV
Short Summary and Take Away Message
- Developing a take home action plan for the delegates
4 Q&A sessions ensure interaction and that your questions are answered.