CMC Primer
CMC Primer explores the essential considerations in drug development known as Chemistry, Manufacturing, and Controls (CMC). It starts by explaining the critical importance of CMC implementation using the Common Technical Document to ensure patient safety. The course then analyzes in detail the significance of CMC across every stage of drug development, from discovery to preclinical and clinical development, ending with post-launch considerations. Furthermore, CMC Primer focuses on the key aspects of CMC, such as Chemistry, Manufacturing, and Controls, through three practical case studies. The course ends by showcasing CMC’s regulatory implications, post-
approval measures, and common challenges encountered in the field. Enroll today and gain insight into CMC’s pivotal role in drug development, manufacturing, and patient safety.
Section 1: CMC Drug Development Considerations
Gain a comprehensive understanding of Chemistry, Manufacturing, and Controls (CMC) in the pharmaceutical industry. By examining the interplay between chemistry, manufacturing, and controls, you’ll grasp how each contributes to pharmaceutical development and regulation. You’ll also learn about the importance of CMC data within the Common Technical Document (CTD) for regulatory compliance. This knowledge equips you to navigate CMC effectively, contributing to pharmaceutical innovation and patient care.
Section 2: CMC In Action
Explore Chemistry, Manufacturing, and Controls (CMC) in pharmaceuticals. You’ll learn about the specific evaluations in Chemistry for drug purity and stability, Manufacturing’s role in quality and compliance, and Controls’ importance for product efficacy and safety. By understanding these elements, you’ll grasp CMC’s vital role in pharmaceutical product lifecycle and industry standards.
Section 3: CMC Regulatory Considerations
Master the critical significance of Chemistry, Manufacturing, and Controls (CMC) from both regulatory and industry perspectives in this section. Discover how CMC data is pivotal in ensuring product quality, safety, and regulatory compliance during the submission process, as well as its role in continuous post-marketing surveillance.Â
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Five Takeaways
- Discuss the purpose of CMC in drug development and manufacturing.
- List the three CMC components and provide an in-depth explanation of their focus.
- Specify what CMC data is found in the Common Technical Document (CTD) and its importance.
- State three reasons CMC is critical to patient safety.
- Identify and compare Control studies for CMC, including the study establishing drug product
shelf life and studying degradation over time.
Features
- Closed Captioning in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
- Transcripts in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
- Course materials
- Real-time tracking
- Progress reporting
- Accessibility features
- Corporate account upgrades
- LinkedIn certificate attachment
- Verified certificates
FAQ
- How long do I have to complete an on-demand course? You have one year from the date of purchase to complete the course. During that year, you may watch the class an unlimited number of times.
- What happens if I don’t complete the course in one year? There are no time extensions. If you want to complete the course, you must purchase it again.
- How long are the on-demand classes? Our longest course has a running time of 90 minutes. However, most have a running time of 45 minutes. The running time is listed for each class on its registration page. The assessment at the end of each course takes between 10-20 minutes to complete.
- Are there any downloadable class materials? No. All course slides and transcripts remain on your Biotech Primer dashboard, but they are always available for review.
- What is the format of the on-demand classes? The online class begins with the class objectives and the course itself and ends with a summary of what you learned. The course is a series of images and text accompanied by a professional voice-over and subtitles. Subtitles are available in 9 languages. The course ends with a quiz to assess your understanding.
- Can I repeat the course? You can repeat the course as often as you like within your one-year access.
- How many times can I take the course quiz? You have three chances to pass the quiz. A passing score is 75% or higher. You must pass the quiz to receive the class certificate. Your quiz score will be shown on your class certificate.
- May I share a course I purchased with others? Each course is to be taken by one individual. If you want to learn as a group, please contact us at training@biotechprimer.com for group pricing.