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CMC Essentials: An Overview of CMC Development
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CMC Essentials: An Overview of CMC Development

17 February 2025 | 1 Week Live Online Course

£795.00 – £1,195.00

(7 customer reviews)

The price is for all 8 Modules | Register for Module 1-Free

Understand the core principles of CMC with this comprehensive introductory course

Register For Module 1 | Free-To-Attend

 

Module 1 of this course is free to attend and delivered online. Register to receive joining instructions for the live event, recording and presentation slides.

Register Early To Save

 

Enrol before 24 January to Save £400 (Feb Course)

Discount has been applied to the price above. VAT, if applicable, will be added.

Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.

Course Overview

 

CMC, Chemistry, Manufacturing and Controls is the term used to describe all the aspects of making pharmaceutical, biologic or cell & gene products. CMC activities begin from product inception and evolve through pre-clinical, clinical and finally marketing approval. Many elements make up CMC with the goal of producing a safe product that is compliant with regulatory requirements.

 

This training course has been designed to provide a complete overview of CMC development from early stages through to clinical trials and marketing approval. You will review key areas such as technology, GMP, process development, quality controls, product lifecycle and analytics. Once completed, you will have a holistic understanding of core CMC activities. This will give you the confidence to progress in your career or interact with CMC technical departments.

 

The course is ideal for those working in CMC related departments, professionals looking to advance their career in CMC and those who regularly interact with CMC departments.

 

With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development.

Learn more about how we deliver classroom and live online training.

Key Learning Objectives

 

  • Understand all the critical steps involved in manufacturing a therapeutic product.
  • Speak the language of CMC so you have the confidence to engage with subject matter experts in technical departments like QC, MSAT or operations.
  • Examine the specific CMC differences between small molecules, biologicals and cell & gene therapies.
  • Be aware of the regulatory requirements of drug approval that affects CMC development.
  • Understand the real-life implications of CMC development- from the nuances of specific products to the general principles of GMP and quality risk management.
  • Understand Module 3 of the Common Technical Document (CTD) and draft its sections for your project.
  • Examine the concept of quality and controls from analytical methods, in-process controls and validation, all the way to Quality by Design (QbD).
  • Know the CMC jargon which will help you work with suppliers and CDMOs.
  • Identify potential CMC gaps and pitfalls in your ongoing projects.

What is Included in a Live Online Course?

 

  • Direct access to an expert trainer.
  • Interactive and engaging sessions with exercises and discussions.
  • Bitesize learning.
  • Access to the Educo Life Sciences Training Portal.
  • Unlimited access to the recordings for 4 to 5 weeks after the last session.
  • A reinforcement session delivered 4 to 5 weeks after the course (online) providing you with extra time with the trainer.
  • A validated certificate of attendance is available for you to download.

Course Dates

 

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

w/c 17 February 2025

1 Week Live Online Training

Register at the top of the page. The largest price saving of £400 will be applied.

w/c 15 September 2025

1 Week Live Online Training

Register at the top of the page. The largest price saving of £400 will be applied.

Group Discount

 

If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.

 

For a quote, complete our contact form by following the link. Get in touch.

Customised Team Training

 

We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.

 

For more information, complete our contact form by following the link. Get in touch.

Free Online Module

 

  • Module 1 is free to attend and delivered online at a date 3 to 8 weeks before the full course start date.
  • To register for module 1, please submit your details in the form located in the agenda.
  • Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.

 

Full Course Information and Pricing

 

  • To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
  • There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
  • The full training course is delivered either online or in a classroom. Please check which course format you have booked.
  • For hybrid training – In the event we do not have enough people on one of the options we will contact you to discuss switching.
  • For live online courses – The dates and times of modules/sessions are subject to change.
  • For live online courses – The module/session durations are approximate.

 

Frequently Asked Questions (FAQs)

Learn more about the course by toggling through the tabs below (Agenda, Trainer and Who Should Attend?)

Post Learning Implementation Plan (PLIP)

Pre-course

  • Access to the Educo Training Portal
  • Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

  • At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

  • Delivered 3 to 4 weeks after the training
  • It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges
Introductory Module 1
FREE to Attend | Live & Recorded

Sign up

16 January 2025 | 60 mins | 1:00 PM UK

Introduction to Drug Development and CMC

  • The Journey of Drug Development
  • The CMC Triangle
  • The Regulatory framework of CMC and Drug Development

Register For Module 1 | Free

There are limited spaces on module 1. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.

By clicking register, you agree to our Privacy Policy

 

Session 1

17 February 2025 | 3.5 Hours | 2:00 PM UK

Module 2: Know Thy Product

  • The Quality Target Product Profile (QTPP)
  •  Product Modalities overview (Drugs, Biologicals, and different Drug Products)
  • Product Characterisation

Module 3: Manufacturing

  • Manufacturing sites and CMOs
  • CMC outsourcing 101
  • Good Manufacturing Practice 101
  • Overview of manufacturing technologies
  • Types of pharmaceutical products and their nuances:
    • Small molecules
    • Biologics
    • Cell therapies
Session 2

20 February 2025 | 3.5 Hours | 2:00 PM UK

Module 4: Manufacturing Process and Pharmaceutical Development

  • Process Development Milestones
  • From Lab to GMP- a typical workflow
  • Technical Aspects of Process Development
  • Raw materials and Starting Materials
  • Upstream process development
  • Downstream and DP Process Development
  • Comparability and Tech Transfers
  • Process Validation and QBD
  • Pharmaceutical Development and Product Lifecycle
Session 3

24 February 2025 | 3.5 Hours | 2:00 PM UK

Module 5: Controls

  • Controls (Overview)
  • Quality Controls (QC)
  • Analytical methods lifecycle and validation
  • Impurities and characterization

Module 6: When the Product Meets the World

  • Stability and shelf life
  • Packaging Labelling and Distribution
  • CMC operations and clinical supply
Session 4

27 February 2025 | 3.5 Hours | 2:00 PM UK

Module 7: Quality (Assurance, Design, and Risk Management)

  • The Pharmaceutical Quality System
  • Quality Risk Management
  • Risk evolution and Phase appropriate GMP

Module 8: The View From the Top of the Development Mountain

  • Course recap
  • Pharma 4.0 and the (near) future
  • Wrap up

Raz Eliav is the founder of Beyond CMC, on a mission to help startups in Drug Development leverage the existing knowledge, know-hows and Data Technologies in reducing development risks, with a focus on the Drug Quality and Manufacturing aspect, known as CMC.

 

Raz Eliav offers hands-on and strategic consulting in CMC Development, Operations and Regulatory Affairs, and training courses in those realms. He brings over 12 years of experience in all clinical development phases and diverse product modalities, mainly Biologicals and Advanced Therapies.

The course introduces you to all aspects of CMC development and is ideal for professionals new to their CMC related role. They will understand how their role contributes to the wider CMC development. It is also ideal for those professionals looking to progress in their CMC career. These include:

  • Quality Assurance (QA)
  • Quality Control (QC)
  • Regulatory Affairs (RA-CMC)
  • Analytical scientists
  • Technicians
  • Bioprocess scientists/engineers
  • Manufacturing operations and development

 

It is also ideal for professionals who interact with CMC departments on a regular basis such as:

  • Management
  • CMC programme managers
  • Project managers
  • Business development and sales
  • Non-CMC R&D
  • Medical experts
  • Computer and data scientists

7 reviews for

CMC Essentials: An Overview of CMC Development

17 February 2025 | 1 Week Live Online Course

  1. Educo Life Sciences –

    This is a new course – Reviews will be added after the first delivery!

  2. Saja Pharma –

    Very informative and well organized course.

  3. SGS –

    The course is well organized. The Trainer led us smoothly through all relevant topics, giving you a lot of important information. At each section underlying appropriate guidelines.

  4. APC (verified owner) –

    n/a

  5. The Health Products Regulatory Authority (Ireland) –

    I gained a huge amount of knowledge and practical understating from this course. The tutor was truly excellent and the information was provided in a very clear and concise manner and in a way that was extremely relevant. I can directly apply the knowledge in my current role and also feel I have upskilled for future roles.

  6. Lonza –

    I really liked the trainer, who was keeping everybody engaged.

  7. Prothya (verified owner) –

    n/a

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