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.
Sale
Sign Up Free Now
21 reviews for
CMC Essentials: An Overview of CMC Development
Starts 23 February 2026 | 4-Day Live Online Course
Original price was: £1,295.£895Current price is: £895.
The price is for all 4-days | Register for Module 1-Free
Understand the core principles of CMC with this comprehensive introductory course
Register before 30 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.
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.
Who Should Attend?
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
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
23, 26 Feb and 2, 3 March 2026 | 12, 24, 28 & 30 September 2026
4-Day Live Online Training
Register at the top of the page. The largest price saving of £400 will be applied.
Introductory Module 1
FREE to Attend | Live & Recorded
Sign up
20 January 2026 | 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
Session 1
23 February 2026 | 3.5 Hours | 2:00 PM UK
Know Thy Product
- The Quality Target Product Profile (QTPP)
- Â Product Modalities overview (Drugs, Biologicals, and different Drug Products)
- Product Characterisation
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
26 February 2026 | 3.5 Hours | 2:00 PM UK
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
2 March 2026 | 3.5 Hours | 2:00 PM UK
Controls
- Controls (Overview)
- Quality Controls (QC)
- Analytical methods lifecycle and validation
- Impurities and characterization
When the Product Meets the World
- Stability and shelf life
- Packaging Labelling and Distribution
- CMC operations and clinical supply
Session 4
3 March 2026 | 3.5 Hours | 2:00 PM UK
Quality (Assurance, Design, and Risk Management)
- The Pharmaceutical Quality System
- Quality Risk Management
- Risk evolution and Phase appropriate GMP
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.
Format, Dates & Times
Find out when this course is running so you can plan your training. Scroll down to view the full agenda.
23, 26 Feb and 2, 3 March 2026
4-Day Live Online Training
Register at the top of the page. The largest price saving of £400 will be applied.
21, 24, 28 & 30 September 2026
4-Day Live Online Training
Register at the top of the page. The largest price saving of £400 will be applied.
On-Demand Access
Can’t wait for the next course date?
Get instant access to the training materials by selecting ‘On-Demand’ from the drop-down menu above. Start learning at your convenience. You’ll also be added to the next live session, giving you the opportunity to attend and interact directly with the trainer if you wish.
Course Times
For live online delivery, each sessions start time and duration can be found under the agenda tab. All times given are UK time.
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.
What is Included?
Certification
Download your official Educo Life Sciences Certificate of Attendance to showcase your achievement and professional development.
Reinforcement Session
Attend a live reinforcement session around four to five weeks after the course to refresh key topics and ask new questions.
Access to Recordings for 5 Weeks
Enjoy unlimited access to all session recordings for up to five weeks after the final session — perfect for revision or catching up.
Learner Reference Guide
Attendees receive an overview packed with key concepts, examples, and references from your training to support you long after the course concludes.
On-Demand or Live Online
This course is delivered live or you can access on-demand materials immediately to begin learning straight away.
15 Hours of Learning
This course includes a total of 15 hours of learning plus the reinforcement session.
Expert Trainer
Engage directly with leading trainers who bring real-world experience and insider knowledge to every session.
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.
Additional Course Information
Free Online Module
Free Online Module
- Some of our courses include a free to attend module 1. Please check above to see if this applies to this course.
- If applicable, 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 above.
- 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
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.
On-Demand Information and Pricing
On-Demand Information
- Most courses are available on-demand. If you select this option you will be able to begin training instantly.
- You will gain access to a previous live online session, slides and learner reference guide.
- You will also be added to the next live session, giving you the opportunity to attend and interact directly with the trainer if you wish.
- Depending on the course length you will have access to the on-demand materials for 1 to 3 months.
21 reviews for CMC Essentials: An Overview of CMC Development
Starts 23 February 2026 | 4-Day Live Online Course
You may also like…
-
Sale
This product has multiple variants. The options may be chosen on the product page
Original price was: £1,395.£995Current price is: £995.Completing the Quality/CMC Module of the CTD
24 & 25 March 2026 | Live Online Training
Related products
-
Stability Testing and Evaluation (ICH Q1E) for Pharmaceuticals
Register Your Interest
-
Sale
This product has multiple variants. The options may be chosen on the product page
Original price was: £895.£716Current price is: £716.Understanding Pharmacokinetics for the Non-Specialist
2, 3 & 4 November 2026 | 3-Day Live Online Course
-
Lean Six Sigma and Error Management for Pharmaceutical Professionals
Register Your Interest
Educo Life Sciences –
This is a new course – Reviews will be added after the first delivery!
Saja Pharma –
Very informative and well organized course.
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.
APC (verified owner) –
n/a
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.
Lonza –
I really liked the trainer, who was keeping everybody engaged.
Prothya (verified owner) –
n/a
Individual –
N/A
uniQure (verified owner) –
N/A
Galapagos (verified owner) –
N/A
Individual (verified owner) –
I very much appreciated the customer service support for registration, the flexibility and problem solving approach.
The training is very well structured in modules and it cover all the aspects of the CMC in drug development with clear explanations. The trainer is fantastic, has very high level of expertise and a real talent in sharing the knowledge. The training material is well organized and making recordings available, allow to review all the big amount of knowledge and support the learning.
Great trainer and great training! Thank you! I highly recommend.
Ludwig-Maximilians-University Munich, Project EpiCure –
Raz is a very experienced and organised trainer who was able to get the content across very well
Batavia Biosciences –
The Educo trainers are not only very knowledgeable in their fields, but have a talent for teaching. They know how to present the topics in a way that is immediately useful for the projects that we are working on. Thank you Educo!
Fresenius Kabi SwissBioSim GmbH (verified owner) –
The course was complete and the interactions were open. So the training sessions were interactive!
Gate2Brain (verified owner) –
CMC essentials was a great opportunity to learn about the complex world from CMC, with a small cohort and a great teacher.
BELUPO d.d. (verified owner) –
This course was great opportunity to get overall view on CMC development process which is not always easy to get from just working experience.
Crinetics Pharmaceuticals, Inc (verified owner) –
The course was extremely informative and helped my role as a clinical trial supply manager make more sense in the broader context of CMC. I heard terms and material from the course referenced in a meeting for my role later the same day!
Interdos Pharma B.V. –
It was an in depth course which gives the learner a good background of information from the conception of designing a new drug, to the steps required to manufacture the drug and putting it on the market. I have 9 years of experience in RA, and I was still able to learn a lot from this course.
Niven Biopharma –
Excellent overview of CMC and all the components and considerations that go into this important function in drug development. The course presented was very knowledgeable and answered all the questions from the participants well.
Locate Bio Ltd (verified owner) –
Course delivery was excellent – I really appreciated that the trainer was able to pause and answer relevant questions effectively during delivery. This helped compound understanding of key topics while the knowledge was still new.
BioNTech SE (verified owner) –
Trainer took the time to answer all the questions by the attendees, which helped to get the most out of the course for me.