Sprecher
Susanne Ding, Boehringer Ingelheim, Germany
Dr Ulrich Kissel, European QP Association
Savvas Koulouridas, Fagron BV, The Netherlands
Aidan Madden, FivePharma, Ireland
Sue Mann, Sue Mann Consultancy, U.K.
Rico Schulze, State Ministry of Social Affairs and Consumer Protection, Saxony, Germany
Lance Smallshaw, UCB, Belgium
Brenda Van Assche, Janssen, Belgium
Dr Ulrich Kissel, European QP Association
Savvas Koulouridas, Fagron BV, The Netherlands
Aidan Madden, FivePharma, Ireland
Sue Mann, Sue Mann Consultancy, U.K.
Rico Schulze, State Ministry of Social Affairs and Consumer Protection, Saxony, Germany
Lance Smallshaw, UCB, Belgium
Brenda Van Assche, Janssen, Belgium
Zielsetzung
Dear Colleagues,
The European Qualified Person Association (EQPA) has developed this Online Education Course for new, trainee and practising Qualified Persons to address general compulsory and regulatory issues. It has been compiled by the EQPA Board of Directors to provide a general idea of the special tasks and responsibilities of a QP, but also to discuss and convey possible solutions to problems addressed in case studies and workshops. Further impacts of the latest developments, specific tasks and detailed discussions will be part of the annual QP Forum of the European Qualified Person Association.
Best regards,
Ulrich Kissel
Chairman of the European Qualified Person Association
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.
Hintergrund
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.
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.
Technical Requirements
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programm
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
Case studies: Certification by a QP and Batch Release - to certify or not, that’s the Question
- Batch release: degrees of freedom and limits
- Batch deviations and QP Certification
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
Case studies: 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
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
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
- Batch certification and release
- Laboratory investigations
Case Studies: Deviations during the Manufacture of an API – What Actions should you take as the responsible QP?
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