2024-06-12 2024-06-12 , online online, 4,000 € plus tax 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 processes
  • 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.

Online course Pharma - CMC-Specialist in Regulatory Affairrs

Qualification course: CMC-Specialist in Regulatory Affairs

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 10019

Book now

JETZT Buchen

Everything at a glance

Appointment

Period

Venue

online

online

Fee
Your contact

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 processes
  • 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.

Ihr Nutzen

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!

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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To make the most of ICH Q12 opportunities, you have to be aware of the relation between ICH guidelines Q8 to Q12 and how...

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CMC for Biologicals

Get your know-how on creating and maintaining quality data for biotech products in our online training.

04.11.2024, online
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CMC dossier requirements for biologics: FDA vs EU

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16.10.2024, online
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Mastering FDA inspections: Preparation and Best Practices

FDA inspection readiness: Gain the knowledge and skills necessary to manage future FDA inspections with confidence and e...

15.10.2024, online
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You start with this module

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