Entry Level CMC MasterClass - US edition
20-21 November, 2023
The Entry Level CMC Masterclass covers the general requirements for small molecules and biologics.
Chemistry, Manufacturing and Control (CMC) is key in the development and routine production of a medicinal product, and this course helps you understand the basic requirements and how to reflect them in the CTD Module 3. The course covers the general requirements for small molecules and biologics.
20-21 November, 2023, Virtual
Time Zone: Eastern Standard Time (EST) / UTC−05:00
Are ICH guidelines compulsory? What is the difference between analytical validation and analytical transfer? Do we need to test a compendial excipient? Chemistry, Manufacturing and Control (CMC) is key in the development and routine production of a medicinal product, and this course helps you understand the basic requirements and how to reflect them in the CTD Module 3. The course covers the general requirements for small molecules and biologics.
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Since 2015, she runs her own consultancy, delivering advice in pharmaceutical development strategies and providing support in writing INDs and IMPDs, CTD Module 3 and QOS, preparing variations and answering questions from health authorities. Her experience covers a wide range of products (small molecules and biologics) and pharmaceutical forms.
Sophie also delivers training courses on European regulations for pharmaceuticals, writing of the Module 3, how to achieve global regulatory compliance, managing transfers of manufacturing sites and preparing variations for the ASEAN region.
Who should attend?
• Quality assurance specialists
• Regulatory Affairs CMC authors or reviewers
• Analytical and stability laboratory
• Project managers with CMC
• Chemistry, Manufacturing & Controls (CMC) regulatory
• Product scientists and test method technical experts (R&D and QC)
• Process analytical chemists and process development scientists
"High attention to detail in course content and very well delivered"
Product Development Manager
"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"
USP PD Team Manager
"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"
Manager, Senior Investigator
MT Sword Laboratories (BMS)
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