2021-12-01 2021-12-01 , Online Online, 3.815,- € zzgl. MwSt. Jan-Jaap Scherpbier, MSc https://www.forum-institut.de/seminar/22122491-qualification-course-cmc-specialist-in-regulatory-affairs/referenten/22/22_12/22122491-qualification-course-pharma-cmc-specialist-in-regulatory-affairs_scherpbier,-msc-jan-jaap.jpg Qualification course: CMC-Specialist in Regulatory Affairs

With this qualification course, you can continue your education in a structured manner in all CMC topics, with a technical focus on development methods, manufacturing processes, CMC documents, change management, and much more.

Topics
    You determine the main topics of the training course yourself. Possible areas of focus are:
  • Development methods
  • Manufacturing pocesses
  • CMC documents
  • Change management
  • Analytics
  • Specifics for biologics
  • Requirements in different countries/regions
  • and more
Aims and objectives
Would you like to have profound know-how in CMC topics, remain flexible in terms of time and set your own content priorities? Then this is right for you.

The concept: You start with a two-day basic seminar "CMC Management in Regulatory Affairs" (talking about the english course) and then select three further seminar modules (= 3 seminar days) that support your professional development.

You will qualify as a CMC-Specialist in a maximum of 18 months (or in just a few weeks) and receive certification from the FORUM Institute.

In this way, you can achieve your training goal efficiently and precisely.
Who should attend

This qualification course is aimed at employees of the pharmaceutical industry and their service providers who require in-depth know-how in CMC topics.

Qualification course: CMC-Specialist in Regulatory Affairs

Qualification course:
CMC-Specialist in Regulatory Affairs

- Qualification course -

Benefits
  • You get the basis in CMC management
  • You choose individually 3 advanced training modules
  • You save up to 30% compared to the regular seminar booking

Webcode 22122491

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Dr. Birgit Wessels
Conference Manager

+49 6221 500-652
b.wessels@forum-institut.de

Details

With this qualification course, you can continue your education in a structured manner in all CMC topics, with a technical focus on development methods, manufacturing processes, CMC documents, change management, and much more.

Topics
    You determine the main topics of the training course yourself. Possible areas of focus are:
  • Development methods
  • Manufacturing pocesses
  • CMC documents
  • Change management
  • Analytics
  • Specifics for biologics
  • Requirements in different countries/regions
  • and more
Aims and objectives

Would you like to have profound know-how in CMC topics, remain flexible in terms of time and set your own content priorities? Then this is right for you.

The concept: You start with a two-day basic seminar "CMC Management in Regulatory Affairs" (talking about the english course) and then select three further seminar modules (= 3 seminar days) that support your professional development.

You will qualify as a CMC-Specialist in a maximum of 18 months (or in just a few weeks) and receive certification from the FORUM Institute.

In this way, you can achieve your training goal efficiently and precisely.

Who should attend

This qualification course is aimed at employees of the pharmaceutical industry and their service providers who require in-depth know-how in CMC topics.

Workshops

Basiskurs: Der CMC-Manager in Regulatory Affairs

Besuchen Sie Tag 1 und Tag 2 des Seminars Der CMC-Manager in Regulatory Affairs und wählen Sie anschließend 3 weitere Module (=Seminartage) aus, die Sie sich aus unter anderem der folgenden Auswahl top bewerteter Seminare frei zusammenstellen können:

Option 1: All about ATMP

Das Seminar All about ATMP ist ein mögliches Wahlmodul (= 2 Module).

Option 2: Analytik kompakt für CMC

Das Seminar Analytik kompakt für CMC ist ein mögliches Wahlmodul (= 1,5 Module).

Option 3: APIs in Regulatory Affairs

Das Seminar APIs in Regulatory Affairs ist ein mögliches Wahlmodul ( = 1,5 Module).

Option 4: Tag 3 Der CMC-Manager in Regulatory Affairs

Tag 3 des Online-Seminars Der CMC-Manager in Regulatory Affairs ist ein mögliches Wahlmodul.

Option 5: ATMPs/Gentherapeutika: Qualitäts- und Risikomanagement

Das Seminar ATMPs/Gentherapeutika: Qualitäts- und Risikomanagement ist ein mögliches Wahlmodul.

Option 6: CMC Documents: Scientific writing for regulatory submission

Das englischsprachige Seminar "CMC Documents: Scientific writing for regulatory submission" ist ein mögliches Wahlmodul

Option 7: CMC für Biologicals

Das Seminar CMC für Biologicals ist ein mögliches Wahlmodul.

Option 8: CTD: CMC-Daten aufbereiten und aktuell halten

Das Seminar "CTD: CMC-Daten aufbereiten und aktuell halten" ist ein mögliches Wahlmodul (= 2 oder 3 Module).

Option 9: GMP-Daten für CMC/Regulatory Affairs kompetent aufbereiten

Das Seminar "GMP-Daten für CMC/Regulatory Affairs kompetent aufbereiten" ist ein mögliches Wahlmodul.

Option 10: IMPD: Anforderungen an CMC-Daten

Das Seminar "IMPD: Anforderungen an CMC-Daten" ist ein mögliches Wahlmodul

Option 11: Qualitäts- und GMP-Know-How für Regulatory Affairs/CMC

Das Seminar "Qualitäts- und GMP-Know-How für Regulatory Affairs/CMC" ist ein mögliches Wahlmodul (= 2 Module).

Option 12: Stabilitätsprüfung - CMC-Know-how

Das Seminar Stabilitätsprüfung: CMC-Know-how ist ein mögliches Wahlmodul.

Option 13: Verunreinigungen in Arzneimitteln - Fokus Nitrosamine

Das Seminar Verunreinigungen in Arzneimitteln: Fokus Nitrosamine ist ein mögliches Wahlmodul.

Option 14: 3 Sendungen aus unserem Portfolio: PharmaFORUM Webcast Biologics

3 Sendungen aus unserem englischsprachigen PharmaFORUM Webcast Biologicszählen als 1 Wahlmodul

The concept

This is how you create your individual training schedule

You attend the two-day basic course "CMC Management in Regulatory Affairs".
Afterwards you participate in 3 further modules (= seminar days), possible options we have mentioned here.
Alternative seminar modules from our portfolio can be selected and we are even happy to design new seminars on request. Please contact us!

Your benefits

  • You receive a comprehensive basis in CMC management.
  • You can individually select the advanced training modules according to your professional orientation.
  • You have up to 18 months to complete your individual training and you can even adapt the training schedule during the course.
  • You save up to 30% compared to individual bookings.
  • You receive a FORUM certificate on successful completion of the qualification .

How to book

This course is so individual that I will be happy to advise you personally. Please contact me directly at b.wessels@forum-institut.de or Tel. 06221 500 652. I will be happy to help you with the module selection and will be happy to assist you with financing questions too.

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