About CMC Writing
The online CMC writing training provides practical training on Chemistry, Manufacturing and Controls (CMC) requirements for drug applications. In fact, the course provides review processes for preformulation, non-clinical to clinical trial regulatory requirements for registration and post approval drug applications. Moreover, the course provides hands-on real life training on how to prepare drug submission dossiers. Hence, This online certificate course in CMC writing is ideal for CMC specialists, regulatory affairs professionals who are handling regulatory filing. Most importantly, this CMC writing course gives hands-on training through simulation on CMC preparation and strategic planning process, which helps to improve the dossier compilation process.
Online Interactive Regulatory CMC Writing Training
This online self paced training. Therefore the course can be accessed 24×7 across anywhere. Hence, the course can be completed at any pace, allowing the user to stop and start at their leisure.
This CMC writing training is ideal for the working professionals who are responsible for the R&D and Technical Writing, Quality Control and Quality Assurance Professionals, Regulatory Professionals specially working in CMC area pre and post approval.
- CMC Specialist
- Regulatory Affairs
- Post approval variation specialist
- Process Chemistry
- Scale-up and Technology Transfer
- Preformation and Formulation Development
- Analytical Chemistry
- Course Code: RYD-98
- Title of the course: Advanced Certification in Regulatory CMC Writing
- Duration: 1 Month. Free extendable up to 3 months.
- Nature of the course: Online learning course. So the course can be accessed online anywhere 24×7.
- Eligibility : Graduation in any discipline. Even final year graduation students can apply.
- Course Certificate: Certificate will be provided at the end of the successful completion of the course.
This online course utilizes interactive learning tools to guide each participant through the steps of CMC Writing process for different regulatory bodies and practical exposure in pre and post submission management. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.
Features of the Course:
- The course provides practical training on drug dossier preparation and submission with more emphasis on cmc writing sections with simulations.
- Therefore it helps the students to develop and nurture CMC writing skills.
- Most importantly, the course provides advanced simulation to real life working in drug dossier preparation and submission process.
- Therefore, this course helps to understand CMC and dossier submission requirements specific to regulatory agencies.
- Above all, this course provides access to sample dossiers to work and develop competency. Certainly, accessing these real life dossiers can be helpful for students to understand section wise requirements for the dossier preparation.
Key Points to Note:
First of all, this course provides practical understanding of the entire drug submission requirement specific to different regulatory bodies.
Secondly, hands-on training is provided on key aspects of the drug dossier preparation with focus on guidelines on dossier preparation.
Thirdly, courses come with how to prepare the different sections of the dossier. In fact, insight is provided on Page by page development of Drug Dossier Preparation. Moreover, the course provides more emphasis on CMC section writing.
Next, one more important point is, this course provides comprehensive understanding on drug master file and site master file preparation.,
To add a note, comprehensive eCTD filing, stability study, documentation error, data integrity and other dossier filing is part of this course.
Some related courses
CMC Writing training content is also part of the International Drug Regulatory Affairs (EPGIDRA) and Drug Biologic Medical Device Regulatory Affairs (PGDBMRA) course. Therefore, a separate course is not required if you already taking EPGIDRA or PGDBMRA course. We also have dedicated Drug Dossier Preparation course which covers the CMC writing.
- Drugs, Biologics, Medical Devices Regulatory Affairs Course
- International Drug Regulatory Affairs
- Pharmaceutical International Business Management
- Drug Regulatory Affairs Course
- ANDA filing
- Stability Study
- Drug Dossier Preparation
Things about CMC Writing you must know.
- What is the difference between Medical Writing and CMC Writing?
- What is Regulatory CMC Writing?
- Importance of CMC Documentation