Georg Göstl, Qualified Person, Takeda, Austria
Dr Ulrich Kissel, European QP Association
Sue Mann, Sue Mann Consultancy, U.K.
Jens-Uwe Rengers, JeRo Consulting, Switzerland
Ewa Rybak, Polpharma Biologics, Poland
Broaden your knowledge of the Qualified Person’s duties and see and discuss which responsibilities and tasks are parts of a QP’s daily life – besides batch certification. With fulfilling these tasks, the QP has a lot of interfaces and interactions. How this can be managed will be a topic in Module B and its pre-course session on soft skills.
Over the last years the role and responsibilities of the Qualified Person have been increasing considerably. As a key person in the company, the QP has to consider many issues and has to take up the challenges within its areas of responsibilities. Additionally, as laid out in Article 49 of the European Directive 2001/83/EC, the QP needs to be highly qualified and experienced. EQPA’s education course modules will help the QP to be well prepared and to be on top of current developments in GMP and regulatory requirements.
New and practicing Qualified Persons who are looking for ongoing training and want to improve their effectiveness and liaison with other functions.
- Which roles are essential for a QP to work efficiently and effectively (e.g. Head of Production, Head of Quality Control, QPPV, QA)
- Identifying the best working practice for QPs working with colleagues in supportive roles
- Links with regulatory authorities and inspectors
Import – Export – Product Flow
- Applicable legislation: a view on Annex 16 and Annex 21
- Different Mutual Recognition Agreements (MRAs)
- What’s expected with regard to Supplier Qualification, Supply Chain Overview, Re-Testing and PQ
Interpretation of Data (with a Focus on Batch Documentation and the PQR)
- Which key figures are relevant for the QP?
- Data verification: determining the acceptability of data
- When is a system or process deemed to be robust?
- Necessary key figures: always easy to understand?
- When is a trend a trend? And what to do with OOT (out of trend)?
Workshop: Interpretation of Data
- Learn how to interpret data and understand the consequences of appropriate and inappropriate performance Parameters
- Evaluate with other delegates the content and lay-out of given examples and discuss it with the speakers
- What is behind “Human Error”?
- What the QP needs to know about it
- Is Human error avoidable?
- Human error and Data Integrity issues
How to ensure that a Batch is in Compliance with the Requirements of its Marketing Authorisation (MA)
- Structure of the MA – which are the relevant parts for the QP?
- How to keep the QP Declaration up to date?
- How can the QP ensure compliance?
- Involvement in Change Control processes
- Challenges for the QP
- Possible Work Flows
Quality Risk Management for the QP
The term “quality risk management” is used throughout Annex 16. But how could the QP use this tool? In this session you will get some practical advice!
QP Involvement in Investigations and CAPA
- QP role in deviation process
- Product deviation
- Process deviation
- Reoccurring deviations
- QP role in handling of product deviations
- Does QP need to be involved in all deviations?
- QP final decision regarding product deviation and Batch certification
- QP involvement in product complaints
- Tools for performing investigations
- The importance of CAPA in the deviation process
- Workshop with examples
Thinking outside the Box: Certification of Plasma Products
New classes of medicines such as ATMPs, Blood and Plasma Products are creating special challenges for the QPs certifying these products. This session aims to provide insight into the challenges when certifying plasma products. Discuss These challenges and see what delegates from different areas can learn from each other.