The course covers the requirements for regulatory submissions, good manufacturing practices, and quality assurance throughout the product life-cycle.
The course also includes topics such as analytical chemistry, biostatistics, process validation, stability testing, and document management.
The course is suitable for individuals involved in the development and manufacture of pharmaceuticals, biologics, and medical devices.
The course is designed to equip the participants with the tools and knowledge needed to manage their agency effectively and comply with the regulatory standards.
Eligibilities
course is a certification program for individuals involved in the development and manufacture of pharmaceuticals, as well as those preparing CMC documents for submission to regulatory agencies. And the course is open for those with pharmaceuticals- chemistry background.
To be eligible for this exam an applicant must meet the following requirements: Choose 3 core courses from a list of topics related to chemistry, manufacturing and controls.
Choose 1 elective course from any of the other classroom courses o Complete the courses within a 36-month period.
Note: Eligibility requirements may vary based on the specific course or program you choose. Please refer to the detailed course brochure for more information.
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(CMCCP) Chemistry, Manufacturing & Controls (CMC) Certified Professional
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