QP Education Course - Recording Online Training

Programm

• The Qualified Person within the EU legislation and regulation framework
• Professional tasks, duties and responsibilities
• Expectations of an EU GMP Inspector

• EU GMP Guide Chapters
• EU GMP Guide Annexes
• Other important News
• What the QP needs to be aware of

• Possible scenarios according to Annex 16
• Mutual Recognition Agreements (MRA)
• Documentation review issues
• The QP in the quality system

• Batch release: degrees of freedom and limits
• Batch deviations and QP Certification

• The world of different Pharmacopoeias
• Pharmacopoeias are more than just Monographs
• How to deal with different methods

• Involvement of the QP
• Role and responsibility of the Head of Quality Control
• Responsibility of the QP

• The QP: ultimate responsibility for the supply-chain of a drug product?
• What is the expected scope of supply chain oversight
• Supply chain integrity
• Active Pharmaceutical Ingredient, Excipients, Bulk and Finished Product
• Shipping under quarantine, ship to label claim, importation testing
• The role of the QP in supplier qualification and auditing
• Written confirmation and QP Declaration
• GMP meets GDP: where does the responsibility end?
• The QP’s involvement in the recall process

• Liability and indemnification of QPs
• Role and responsibility of head of production and head of quality control (when things go wrong)
• Role and responsibility of upper management (when things go wrong)
• Delimitation of responsibilities with QPs in the same company
• Delimitation of responsibilities with QPs at a contractor

• How much involvement is needed in systems like:
• Product Quality Review
• Inspection Management
• Batch Record Review
• CAPA
• Change Control
• Validation
• Complaints and recalls
• Batch certification and release
• Laboratory investigations