概览

The regulations surrounding Chemistry, Manufacturing, and Controls (CMC) can often seem daunting and challenging. However, with proper training and by knowing where to look among FDA regulations and other important resources, you can become an informed and knowledgeable regulator who can tackle CMC issues. This on-demand course has been assembled for the beginner in CMC as well as the intermediate professional who is looking for a refresher course in several facets of CMC. This course will review the tools to write and/or assemble CMC sections of regulatory submissions (INDs, NDAs, DMFs, ANDAs, etc.), prepare for and orchestrate CMC meetings with the FDA, and provide a clear understanding of how to avoid noncompliance. While the course is primarily focused on CDER and some CBER-related products, some biologics and device CMC-specific requirements will also be addressed.

This on-demand training course takes an average of 10.75 hours to complete. Learners have access to the course for one year from the date of purchase.

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FEATURED TOPICS
- Selected types of submissions affected by chemistry, manufacturing, and controls (CMC)
- The drug development process
- Pre-formulation and formulation development
- Requirements for an Investigational New Drug
- The EU Investigational Medicinal Product Dossier
- Environmental impact (IND and NDA)
- Designing the clinical trial material label
- Special Protocol Assessment
- Drug Master Files
- Common Technical Document (CTD) and Electronic CTD (eCTD)
- Designing the final New Drug Application labels
- FDA briefing package
- Preparing for CMC meetings with FDA
- Designing a Stability Protocol and Contents of a Certificate of Analysis (COA)
- CMC inspections – Pre-Approval Inspection (PAI)
- FDA enforcement actions – Form FDA 483 and warning letters
- Beyond approval – post-approval changes
- Changes reportable in an Annual Report
- Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children (BPCA)

谁应该参加？

This course is designed for professionals involved in or interested in learning about:

Regulatory affairs professionals
Quality assurance and compliance personnel
CMC and manufacturing personnel
CMOs, clinical supplies personnel, and those involved in drug development requiring some CMC background
IP professionals who would like to obtain a better understanding of the CMC processes
Document management personnel who assemble CMC sections and would like to have a clear understanding of CMC and the eCTD modules

学习目标

At the conclusion of this course, participants should be able to:
- Recognize FDAs regulatory expectations and the regulatory framework
- List the CMC sections of INDs/NDAs/CTDs/DMFs
- Define the CMC sections of INDs and NDAs/CTDs
- Identify regulatory documents affected by CMC
- Outline the FDA expectations regarding pediatric formulations
- Distinguish how to design labels required for INDs and NDAs
- Identify the FDA inspection process and how to avoid or minimize 483s and Warning Letters
- Determine ways to construct a stability protocol

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Navigating Chemistry, Manufacturing, and Control Through the Drug Development Process

概览

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谁应该参加？

学习目标

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