Program Objective

The objective of this training program is to equip the learner with comprehensive, end-to-end knowledge of Chemistry, Manufacturing, and Controls (CMC) as it applies to the development, registration, and lifecycle management of pharmaceutical drug substances and drug products, including biologics and advanced therapies. Upon completion, the learner will be able to independently navigate global regulatory requirements for CMC submissions (FDA, ICH), understand phase-appropriate CMC development, select and justify starting materials, establish control strategies, manage manufacturing changes, validate analytical procedures, and ensure product quality throughout the product lifecycle.

Program Scope

This program covers the full spectrum of CMC activities from early clinical development through commercial manufacturing and post-approval changes. The scope includes:

• Regulatory framework for CMC: 21 CFR Parts 210, 211, 312, 314, 601; ICH guidelines Q8, Q9, Q10, Q11; and CTD format (M4Q).
• Phase-appropriate CMC requirements for Phase 1, Phase 2, and Phase 3 INDs, and BLAs/NDAs.
• Drug substance development: synthesis, characterization, impurities (Q3A, Q3C, Q3D, M7), and specifications.
• Drug product development: formulation, manufacturing process, container closure systems, and stability (Q1A).
• Analytical procedures: development, qualification, validation (Q2), and reference standards.
• Process validation and continued process verification.
• Control strategy, design space, and Quality by Design (QbD).
• Starting material selection and justification (Q11).
• Post-approval changes: reporting categories (PAS, CBE, Annual Report) under 21 CFR 314.70.
• Comparability protocols and lifecycle management.
• Pharmaceutical Quality System (Q10) and Quality Risk Management (Q9).

Target Audience

• Chemistry, Manufacturing, and Controls (CMC) regulatory affairs professionals.
• Pharmaceutical development scientists (drug substance and drug product).
• Quality assurance and quality control personnel in pharmaceutical and biologics manufacturing.
• Analytical chemists and method validation specialists.
• Process development engineers.
• Regulatory affairs associates preparing INDs, NDAs, BLAs, and supplements.
• Auditors and inspectors reviewing CMC sections of regulatory submissions.
• Graduate students and researchers transitioning to industry CMC roles.

Certification

Learners who successfully complete the program will receive a dated, traceable certificate that provides verifiable proof of their achievement for professional records.