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Making pharmaceuticals is complex.

If you have just recently joined a QA team, Project management, or Regulatory Affairs and suddenly come in touch with the full picture of CMC, you are probably overwhelmed by the sheer amount of nuance and jargon.

It's too late to ask the basic questions- everyone around you speaks fluently, and you have the feeling "you should know by now"... 

What is the QTPP and CQAs?

What's the scope of GMP? 
 
Who is responsible for Quality?

Why is the world of Biologicals and Cell therapies so much more complex than Chemistry alone?

What are the key guidelines in the field that everyone must know?

And why oh why, didn't anyone teach us all that in one introductory course, when we were still in University?!

What if you could speak  fluently with the experts? 


Feel confident that you know enough not be afraid that the question is "too basic"?

 

Have a mental picture of the underlying context of ALL the moving parts in CMC:

  • Manufacturing and GMP

  • Quality Controls and Quality Assurance

  • Quality by Design

  • The Regulatory framework

Join us in the mini-course:

CTD Module 3- The Full Story of CMC

This mini-course is directly continuing the Free crash course on Drug Development and CMC- if you haven't taken it, please start there and come back when you are ready.

In this mini-course, we will map out the full picture of CMC as a first step in our deeper journey of the CMC Essentials Training Course (See below).

We will discuss:

  • The Regulatory framework of CMC:

    • Key guidelines and how to use them

    • Highlights on GMP

    • Module 3 of the CTD

    • Phase-appropriate GMP

  • We will expand on the main pillars of CMC and review:

    • Types of drug products- from small molecules, to cell therapies, and from pills to parenterals.

    • Manufacturing processes (Upstream, downstream, aseptic and all that's in-between)

    • Quality controls, Quality Assurance and of course- Quality by Design

COO in Software development

The module three roadmap was helpful. I enjoyed listening to the flow and relationships between sections.

Lead Scientist in a Cell-therapy startup:

As a beginner, I found the "CMC Essentials" course to be an excellent introduction to the field. The course was engaging, comprehensive and well-presented. I have definitely gained a valuable knowledge.

Data scientist in Software development:

For me with limited knowledge in the pharmaceutical production domain, it was very helpful 

Project manager at a CMO:

Loved the way it gave an overview of CMC world. Was extremely easy to follow-through.

Housekeeping

  • The course is self-paced interactive meaning:

    • Video-lessons are available on-demand (also as audio-only stream)

    • Student's forum open for Q&A  and discussion

    • Live weekly meeting for Q&A in The Treeclub 

  • Minimum Time commitment: 20-30 minutes per day over 1 working week (Extra materials will be provided for those who wish to dive deeper).

  • As a Mini-course student, you get a 1-month access to the course materials and the Tree club sessions.

  • Course is coming live very soon! Until then, you can benefit from an early birds discount: EARLYBIRD

99

Crash course: The Journey of Drug Development + Certificate

Mini-course: The Full Story of CMC + Certificate

Participate in live Tree club meetings

1-month Access to Tree club recordings and student forum

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