CMC Essentials: An Overview of CMC Development
Days
Hours
Minutes
Seconds
This course includes:
-
Collaborative environment that
encourages interaction - Case studies and Q&A sessions
- Training materials
-
Tools and techniques to apply
immediately in your role - Recording access
- Certificate of completion
Course outline
Understanding Chemistry, Manufacturing & Controls (CMC) is critical for ensuring regulatory compliance, product quality, and successful drug development. Regulatory bodies such as the FDA, EMA, and ICH require a well-structured CMC dossier that meets evolving industry standards.
This three-day masterclass will equip professionals with the essential knowledge to manage CMC documentation, regulatory expectations, GMP compliance, and lifecycle management. Gain expert insights into process validation, analytical controls, and quality risk management to streamline CMC strategies from R&D to commercialization.
Key Takeaways
- Master CMC regulatory requirements in alignment with FDA, EMA, and ICH guidelines.
- Develop expertise in QbD (Quality by Design) & risk management for process control.
- Enhance knowledge of GMP compliance and its impact on CMC documentation.
- Optimize manufacturing & technology transfers for seamless scale-up.
- Understand lifecycle management and how to keep CMC dossiers up to date.
Who Should Attend?
- CMC Documentation Specialists & Project Managers
- Regulatory Affairs & Compliance Professionals
- Quality Control (QC) & Quality Assurance (QA) Managers
- Pharmaceutical Scientists & Formulation Experts
- Process Development & Manufacturing Scientists
- Stability & Analytical Development Experts
Agenda Highlights
Day 1: Fundamentals of CMC Development
- Quality Target Product Profile (QTPP) & CMC dossier structure
- Manufacturing strategies & GMP considerations
Day 2: Process & Pharmaceutical Development
- API development, risk assessment & QbD
- Analytical method validation & regulatory control strategy
Day 3: Quality, Compliance & Lifecycle Management
- Stability testing, GMP compliance & risk management
- Regulatory updates & dossier maintenance
About Trainer
Dr. Helmut Vigenschow is a renowned CMC and pharmaceutical expert with over 30 years of industry experience. He has held senior roles in Quality Control, Project Management, and Regulatory Affairs and has led CMC training programs for global pharma companies. As a consultant and lecturer, he specializes in GMP compliance, CMC strategy, and regulatory dossier management.
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Companies Represented By Our Participants
Proud Stories
★★★★★
Marsha Miller
Pragmatic approaches and clarification on when statistics is useful and when not. Perfect guidance through the official guidances out there and pointing out where they are sometimes contradictory and therefore confusing during application in daily work. Very honorable teacher and very good at making complex things understandable. As the head is spinning after such intense training, the hand-outs and workshop documentation given will help in having the learned content re-called
★★★★★
Michael Durschlag
James provided a comprehensive, detailed, and complete view of Annex 1 updates, tied it to QRM and to PICS guidance. He delivered the material in an easy-to-understand format, and we did not experience any problems with the streaming. The slide material provided will be very useful as a reference.
★★★★★
Nancy Musik
This was a very in-depth training, and I especially appreciated the real-life examples or possible solutions and real industry examples and mitigation approaches. Trainer definitely a SME on this subject and was able to provide lots of information and background details to explain Annex 1 intentions.
★★★★★
Vyara Kuneva
The training offered a large scope of relevant information, presented in an understandable and interesting way. The hands-up approach, supported by examples and simulations makes the content easy to understand and remember. The lecturer was excellent, and the course was very well organized.
★★★★★
Walter Drexler
I have never seen such an extensive session on statistics for practitioners on all these burning topics provided. It basically covers all of them we also discuss in our company. A great spectrum of topics covered.
★★★★★
Seth Byers
Well organized presentation, very knowledgeable presenter, great atmosphere
★★★★★
Hassan Abdu Al Asmary
Touched my needs, Mr. James is a wonderful lecturer who made it easy and clear.
★★★★★
Gabriela Saucedo
The facilitator and expert, the documents shared, the excellent facilitation skills of James and being engaged in the session.
★★★★★
Vassia Papakonstantinou
I really liked the flow of the presentation, and the way modules were explained using the appropriate ICH references
★★★★★
Nereus Jethro Abad
I enjoyed the class and found it informative, engaging and filled with valuable insights.
What you'll get?
-
Collaborative environment that
encourages interaction - Case studies and Q&A sessions
- Training materials
-
Tools and techniques to apply
immediately in your role - Recording access
- Certificate of completion
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