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Biomanufacturing, Biotech Courses, CGT Courses, CGT Manufacturing, Manufacturing & Quality, Pharmaceutical Training Courses
CMC Essentials: An Overview of CMC Development
30 October 2023 | 1 Week Live Online Course
£995.00
The price is for all 11 Modules | Register for Module 1-Free
Understand the core principles of CMC with this comprehensive introductory course
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.
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
- Reinforcement session delivered 4 to 5 week after the course (online) providing you with extra time with the trainer
- A validated certificate of attendance available for you to download
Register For Free Online Session
There are limited spaces on the introductory session. 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.
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.
Learn more about the course by toggling through the tabs below (trainer, agenda, 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
28 September 2023 | 60 mins | 1:00 PM UK
Pharmaceutical development – Overview and context
- The journey of drug development: – from bench to bedside
- The regulatory paradigm for drug approval
- The CMC Triangle and Module 3 of the CTD
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.
Module 2
30 October 2023 | 90 mins | 1:00 PM UK
The big picture of CMC
- The pillars of CMC (Chemistry, Manufacturing and Controls)- expansion and interrelations
- The regulatory context of CMC and regulatory authorities
- CTD Module 3
- CMC in practice and introduction to GMP
Module 3
30 October 2023 | 90 mins | 2:30 PM UK
The science and technology of CMC
- Types of pharmaceutical products and their nuances
- Small molecules
- Biologics
- Cell therapies
- Key manufacturing technologies- principles of organic chemistry, molecular biology
- Review common upstream and downstream technologies
Module 4
31 October 2023 | 90 mins | 1:00 PM UK
Manufacturing sites and GMP
- Manufacturing sites (In-house/CDMOs)
- Good Manufacturing Practice (GMP) 101
- From lab to GMP- a typical development workflow
Module 5
31 October 2023 | 90 mins | 2:30 PM UK
Manufacturing process development (drug substance)
- Upstream process development, starting materials and cell banks
- Downstream process development
- Process “lock” and Comparability (intro)
- Review the differences in process development between small molecules, biologics and cell therapies
Module 6
1 November 2023 | 90 mins | 1:00 PM UK
Pharmaceutical development and product lifecycle
- Pharmaceutical and formulation development
- Drug product process development
- Containers and labelling
- Case studies of specific product types
- Comparability
- Technology Transfers
- Review the differences between small molecules, biologics and cell therapies
Module 7
1 November 2023 | 90 mins | 2:30 PM UK
Know your product- characterization and impurities
- Characterization principles and techniques
- Types of impurities and their significance in product safety/efficacy
- Review the differences in characterisation between small molecules, biologics and cell therapies
Module 8
2 November 2023 | 90 mins | 1:00 PM UK
Quality Controls (QC)
- Analytical methods overview
- Quality Controls (QC) and Specifications
- Analytical methods lifecycle and validation
Module 9
2 November 2023 | 90 mins | 2:30 PM UK
When the product meets the world
- Stability and shelf life
- CMC operations and product logistics
Module 10
3 November 2023 | 90 mins | 1:00 PM UK
Quality and design
- Quality Assurance (QA)
- Pharmaceutical quality systems
- Quality risk management
- Introduction to Quality by Design (QbD)
Module 11
3 November 2023 | 90 mins | 2:30 PM UK
The view from the top of the development mountain
- Quick recap of all course topics
- Pharma 4.0, PAT, IoT, big data and current tech stack
- Predictive modelling and AI
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
Free First Module and Pricing
- Module 1 is free to attend and is delivered online and is recorded.
- To enrol onto module 1, please submit your details in the form.
- Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.
- There are price tiers for this course. The dates of these are at the located above the course overview.
Could your team benefit from this course?
We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.
For more information you can email us at [email protected] or call +44 (0) 203 111 7357.
Complete our contact form by following the link. Get in touch.
| * | • The training course is delivered either online or in a classroom. Please check which course format you have booked. |
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Educo Life Sciences –
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