European QP Association (EQPA), KisselPharmaConsulting
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
Objectives
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.
Background
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.
Target Group
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.
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?
Testimonials
Seminar Programme as PDF