German Qualified Person Association

Login
Bitte geben Sie Ihren Benutzernamen und Ihr Passwort ein:

Benutzer:

Passwort:

Nach Verlassen der Website angemeldet bleiben
Bitte klicken Sie hier, wenn Sie Ihr Passwort vergessen haben.
   

Events

Unsere Event-Seite informiert Interessierte über alle geplanten Events der German QP Association sowie andere relevante Veranstaltungen die im Interesse der Sachkundigen Person liegen.

Wir freuen uns über Ihr Interesse !

Qualified Person Education Course

Live Online Training: Qualified Person Education Course
(Module B) – Mastering the QP Role in daily Practice

30 June / 1 July 2021

Broaden your knowledge of the Qualified Person’s duties and see and discuss which responsibilities and tasks are parts of a QP’s daily life – besides batch certification. With fulfilling these tasks, the QP has a lot of interfaces and interactions. How this can be managed will be a topic in Module B and its pre-course session on soft skills.

Programme

  • QP Interfaces
  • Import – Export – Product Flow
  • Interpretation of Data (with a Focus on Batch Documentation and the PQR)
  • Interpretation of Data
  • Human Error
  • How to ensure that a Batch is in Compliance with the Requirements of its Marketing Authorisation (MA)
  • Quality Risk Management for the QP
  • QP Involvement in Investigations and CAPA
  • Thinking outside the Box: Certification of Plasma Products

Klicken Sie hier, um mehr zu erfahren und die Veranstaltung zu buchen.


Qualified Person Education Course

Live Online Training: Qualified Person Education Course
(Module A) – Understand the Implications of becoming a QP

26/27 October 2021

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.

Programme

  • The Legal and Professional Duties of the Qualified Person
  • Update on European Requirements
  • Delegation of Duties and Responsibilities
  • Case Studies: Certification by a QP and Batch Release (to certify or not)
  • Case Study: Deviations during the Manufacture of an API – What Actions should you take as the responsible QP?
  • What the QP needs to know regarding the Supply Chain (from Supplier Qualification to GDP)
  • How the QP fits into the Quality Systems
  • Liability and Indemnification
  • What the QP needs to know about Pharmacopoeias
  • Case Studies: What the QP needs to know about OOS/OOT

Klicken Sie hier, um mehr zu erfahren und die Veranstaltung zu buchen.


Virtuelles Mitgliedertreffen der GQPA

Die Mitgliederversammlung fand am Abend des 24. April 2021 Live Online statt. Weitere Informationen finden Sie hier.

Klicken Sie hier, um mehr zu erfahren.

 . Impressum . Datenschutz . Cookie-Einstellungen .