CMC Regulatory Affairs Professional Certificate
About 16 hours
Written for chemists, process engineers, and QA/QC staff who want to move into CMC regulatory roles.
$395 per person. Online and self-paced.
Who it is for
Chemists, process engineers, and QA/QC staff who want to move into CMC regulatory roles.
What you will learn
- Outline Module 3 content for a small molecule and a biologic
- Link CQAs and process parameters to a control strategy
- Classify a manufacturing change and choose the correct US filing category
- Use ICH Q12 tools to reduce post-approval filing burden
- Plan a comparability exercise for a biologics process change
How it works
Online and self-paced
The lessons are online, with an audio version of each, so you can study at your own pace.
Earn a certificate
Finish every lesson to receive a certificate with a unique ID that anyone can verify.
Enroll online
Pay securely by card, Apple Pay or Google Pay. Your account is ready as soon as the payment goes through.
Questions about this program
How long does CMC Regulatory Affairs Professional Certificate take?
About 16 hours of study. It is online and self-paced, so you can spread it over the weeks that suit you.
Who is this program for?
Chemists, process engineers, and QA/QC staff who want to move into CMC regulatory roles.
Do I get a certificate?
Yes. When you finish every lesson you receive a digital certificate of completion with a unique ID that anyone can check at regulatedscience.org/verify/. You can add it to your LinkedIn profile.
Is there an audio version?
Yes. Every lesson has an audio version, so you can listen on the go.
How much does it cost?
$395 per person. Email support@regulatedscience.org for team pricing.
How do I enroll?
Select "Enroll" on this page and pay securely by card, Apple Pay or Google Pay. Your account is ready as soon as the payment goes through.
Can my team take it together?
Yes. We offer group enrollment for companies, CROs and consultancies. Email support@regulatedscience.org with the programs and the size of your team.
Not ready to enroll?
Leave your email and we will send you the syllabus and news about this program. You can ask us to remove it at any time.
