Introduction to CMC Regulatory AffairsCOURSE CALENDAR
What Is Introduction to CMC Regulatory Affairs Training?
This course will give delegates the understanding how to achieve good quality IMPD and MAA submissions.
Who Should Attend
An introductory course for those with minimal experience in CMC or new to the discipline.
- CMC in the drug development programme
- Drug substance - characterisation and synthesis related issues
- Drug master files and Certificates of Suitability
- Drug product and formulation considerations
- Control of Drug Substance and Drug Product
- Setting specifications - drug substance and drug product
- Stability - drug substance and drug product
- The Quality Overall Summary
- What level of CMC detail is needed in the IMPD in relation to clinical phases.
Available onsite or nationwide at any of over 50 centres, see below our open course availability. Alternatively, call 0844 335 8882.
The Introduction to CMC Regulatory Affairs course is accredited by the most recognised certificating body in the UK and supported by certification and credit card sized ID cards produced by XYZ Training Group - one of the UK's largest dedicated Industrial training organisations.
We train in excess of 100,000 delegates per year. For more information, please make your enquiry using the form below. The XYZ Training Group Customer Charter ensures that all enquiries are responded to the same day.
Available on client premises as an in-house course or at one of training venues, provided minimum delegate numbers are achieved. Whatever your requirement, simply complete the enquiry form below and we'll send you our quotation by return.
Make A Introduction to CMC Regulatory Affairs General Enquiry Here
Complete the form below and we'll send you some training options and / or a quote by return. Please only use this form if you are interested in Introduction to CMC Regulatory Affairs courses. For all other enquiries, please use the general contact page, refine your search above or call us on 0844 335 8882.