The Legal and Professional Duties of the Qualified Person
- The Qualified Person within the EU legislation and regulation framework
- Professional tasks, duties and responsibilities
- Expectations of an EU GMP Inspector
Update on European Requirements
- EU GMP Guide Chapters
- EU GMP Guide Annexes
- Other important News
- What the QP needs to be aware of
Delegation of Duties and Responsibilities
- Possible scenarios according to Annex 16
- Mutual Recognition Agreements (MRA)
- Documentation review issues
- The QP in the quality system
Workshop on Case Studies: QP Discretion and Batch Certification
- Batch certification: degrees of freedom and limits
- Batch deviations and QP Certification: To certify or not, that’s the question
What the QP needs to know about Pharmacopoeias
- The world of different Pharmacopoeias
- Pharmacopoeias are more than just Monographs
- How to deal with different methods
Workshop: What the QP needs to know about OOS/OOT
- Involvement of the QP
- Role and responsibility of the Head of Quality Control
- Responsibility of the QP
What the QP needs to know regarding the Supply Chain (from Supplier Qualification to GDP)
- 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
How the QP fits into the Quality Systems
- How much involvement is needed in systems like:
- Product Quality Review
- Inspection Management
- Batch Record Review
- CAPA
- Change Control
- Validation
- Complaints and recalls
Liability and Indemnification
- 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
Workshop: Deviations during the Manufacture of an API – What Actions should you take as the responsible QP?