European QP Association (EQPA), KisselPharmaConsulting
Dr. Jens-Uwe Rengers
vorm. Akorn
Ewa Rybak
Polpharma Biologics
Dr. Sue Mann
Sue Mann Consultancy
Objectives
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.
Background
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.
Target Group
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
Human Error
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
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
Case studies: What the QP should know about
Pharmaceutical Quality System
Batch Record Review
Management Review (With possibility for interaction)
Testimonials
Seminar Programme as PDF