Dr Ulrich Kissel
European QP Association (EQPA), KisselPharmaConsulting
Referent:innen
Dr. Julia Gudd
Behörde für Justiz und Verbraucherschutz (BJV)
Dr Lance Smallshaw
UCB Pharma
Aidan Madden
FivePharma
Savvas Koulouridas
Fagron BV
Dr. Sue Mann
Sue Mann Consultancy
Zielsetzung
Broaden and intensify your knowledge of the Qualified Person’s duties and responsibilities. Experts from the EQPA Board of Directors, pharmaceutical industry and regulatory authority will share their experience on important issues of the QP’s daily business and will give first-hand information on current and future expectations.
Hintergrund
Over the last years the roles and responsibilities of the Qualified Persons 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. This education course is one important part to help the QP be on top of current developments in GMP and regulatory requirements.
Zielgruppe
New and future Qualified Persons, QPs who are looking for ongoing training and personnel who want to get a detailed overview of the role and responsibilities of a QP.
Programm
Gesamtes Programm als PDF herunterladen
The Legal and Professional Duties of the Qualified Person
- The EU legislation and regulation Framework
- Requirements for becoming a QP
- Role and duties of a QP
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
- Duties and responsibilities of a QP (summary)
- Delegation of duties and responsibilities
- Annex 16
- Importation
- Assessments by others - Summary
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)
- Introduction to Supply Chains and expectations
- QP´s role in supplier qualification and auditing
- Written confirmation and QP Declaration
- GMP meets GDP: where does the responsibility end?
- QP’s involvement in the recall process
- QP’s role in drug shortages
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
- Responsibility in the pharmaceutical Industry
- Types of drug-related product liability Claims
- Advanced tips -trends in liability
- Examples (interactive part)
Workshop: Deviations during the Manufacture of an API – What Actions should you take as the responsible QP?
| ECA-Member*: | € 1690,- |
| Non ECA Member*: | € 1890,- |
| EU/GMP Inspectorates*: | € 945,- |
| QP Member Discount*: | € 1690,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
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E-Mail: info@concept-heidelberg.de
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Seminarprogramm als PDF
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