GLP, GMP and quality control with Prof. Dr. Mona Tawab
1 March 2024 | 9:00 – 17:00 | in person workshop
This course will give a comprehensive overview on the concept of quality assurance in the framework of the pharmaceutical industry, including fundamental aspects and tools applied in practice, with an emphasis on GMP. Modern approaches of risk assessment will be addressed just as the implementation of CAPAs (corrective and preventive actions), dealing with OOS (out of specification) results and realizing change control in a fixed process. Also data integrity is an important issue of the course. Practical units at the end of the course will give participants the chance to practically implement the knowledge acquired on the example of case studies.
In details the course will deal with the:
- need for and origin of quality assurance
- concept and definition of quality
- regulatory key players and requirements
- applied quality standards on the example of GMP
- main pillars of a quality assurance system
- modern tools in quality assurance (risk analysis, CAPA, change control, OOS….)
Workshop: Wie funktioniert ein Unternehmen?
26.02.2024 | 9:00–13:00 Uhr | in Präsenz (Campus Westend)
In diesem Workshop erhalten Sie einige grundlegende Informationen über Wirtschaftsunternehmen, die Ihnen im Bewerbungsverfahren und zum Berufsstart hilfreich und nützlich sein können. Wir schauen uns die Aufbau- und Ablauf-Organisation eines typischen Unternehmens an und sprechen über die Unterschiede zwischen Projekt- und Linienarbeit. Sie lernen die typischen Rollen und Funktionen in einem Unternehmen, die üblichen Berichtslinien und Entscheidungsprozesse kennen.
In diesem Workshop behandeln wir keine fachlichen Themen, sondern schauen uns an, wie ein Unternehmen ganz grundsätzlich funktioniert.
Diese Informationen geben Ihnen Sicherheit und Orientierung im Bewerbungsprozess und helfen Ihnen dabei, sich in einem Unternehmen schneller zurecht zu finden. Im Rahmen des Workshops können wir Ihre konkreten Fragen behandeln und konkrete Bewerbungsideen diskutieren.
Petra Becker-Horn, Bo-Ho Consulting, hat über 30 Jahre Erfahrung in verschiedenen Unternehmen in unterschiedlichsten Branchen und in unterschiedlichsten Rollen. Sie hat als Mitarbeiterin, Controllerin, Führungskraft, Projektmanagerin, Organisationsentwicklerin und externe Beraterin gearbeitet und dadurch einen tiefen Einblick in die Strukturen und die Kultur von Wirtschaftsunternehmen.
Miniserie: Einblicke und Einstiegsmöglichkeiten in die pharmazeutische Industrie
Referent: Dr. Felix Kern | online | Sprache: Deutsch
Teil 1: Regulatorische Grundlagen, Mittwoch, 17.01.2024 (17:00 – 18:00)
Teil 2: Qualitätskontrolle, Mittwoch, 24.01.2024 (17:00 – 18:00)
Teil 3: Pharmazeutische Produktion, Montag, 29.01.2024 (17:00 – 18:00)
Teil 4: Quality Assurance, Mittwoch, 06.02.2024 (17:00 – 18:00)
Teil 5: Audits, Mittwoch, 14.02.2024 (17:00 – 18:00)
GRADE Career Talk: "Hello Doctor - Daily live of a Medical Science Liaison" - Dr. Claus Schuh (GSK, Switzerland)
10. January 2024 | 16:30 | online
After studying life sciences and finishing a PhD most of us face the reality of “What the heck do I do now?”. Career fairs and PhD programs provide more and more ideas what to do next but often it is not clear what industry jobs really are about.
Medical Affairs is rather young function in pharmaceutical companies and is still developing and shaping. In short Medical Affairs provides the non-sales connection to Health Care Professionals (HCPs), Patient Organizations and the connection to Clinical Research, but also provides medical expertise inside the company to other functions. In this career talk I would like to give you an idea what Medical Affairs jobs there are in the pharmaceutical industry, how a normal week is looking like for office based and field based roles, how I came to Medical Affairs and what skills are helpful to get you there.
Since Medical Affairs is an integrative function in most pharma companies, I can also provide you some side views on what my colleagues in e.g. Marketing & Sales, Compliance, Market Access and Regulatory Affairs are doing if you are interested in these functions.
Dr. Claus Schuh studied Biology at the Technical University of Kaiserslautern in Germany before doing his PhD on “Prostanoids in central and peripheral pain processing” at Gerd Geisslinger‘s Institute of Clinical Pharmacology of the University Hospital Frankfurt in the group of Klaus Scholich. Afterwards, he worked six years as a Postdoc at the Institute of Anatomy of the University of Zurich (UZH) establishing and developing in vivo renal Multiphoton Imaging in the mouse. After a short project as coordinator for clinical studies at the University Hospital Zurich he joined Sandoz/Novartis Switzerland as Medical Scientific Liaison/ Medical Advisor in July 2020. In 2023 he joined GSK in Switzerland as field based MSL.
English version
