Qualified Person Education Course Module B

Programm

Gesamtes Programm als PDF herunterladen

• 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

• 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

• 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)?

• 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

• 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

• 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

• Pharmaceutical Quality System
• Batch Record Review
• Management Review
  (With possibility for interaction)