Program Description

The Regulatory CMC Essentials Certificate is a comprehensive, competency-based training program designed to build foundational expertise in global pharmaceutical quality and Chemistry, Manufacturing, and Controls (CMC) regulation. Centered on the International Council for Harmonisation (ICH) Q6–Q10 and Q12 guidelines, this certificate provides learners with the critical, foundational knowledge required to navigate quality expectations across the product lifecycle including using the science and risk-based approach—from development and manufacturing to change management and continual improvement.

Participants will explore key regulatory frameworks that govern product specifications, GMP for active pharmaceutical ingredients, quality risk management, pharmaceutical quality systems, and lifecycle change management. Through clear explanations, case-based learning, and practical application of regulatory concepts, learners gain a foundational understanding of how these guidelines work together to ensure product quality, compliance, and regulatory success.

This certificate is ideal for professionals in Quality Assurance, Regulatory Affairs (CMC), Manufacturing, Technical Operations, Process Development, Validation, and Tech Transfer, as well as those transitioning into CMC focused roles.

Learning Outcomes

Upon completion of the program, participants will be able to:

• Interpret the roles and scope of ICH Q6–Q10 and Q12 within global pharmaceutical regulation.
• Apply regulatory expectations for drug substance and drug product specifications for small molecules (Q6A).
• Understand current principles and practices of GMP for active pharmaceutical ingredient manufacturing (Q7).
• Explain foundational elements of pharmaceutical development and Quality by Design (Q8).
• Understand the importance of Quality Risk Management principles (Q9).
• Describe the Pharmaceutical Quality System and its application across the product lifecycle (Q10).
• Apply ICH lifecycle management concepts, including post approval change frameworks including use of established conditions (Q12).
• Integrate Q6–Q10 and Q12 concepts to support compliant development, technology transfer, and commercial production activities.

Program Structure

The certificate comprises a sequence of six online, self-paced courses:

1. ICH Q6 – Specifications: Test Procedures and Acceptance Criteria
2. ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
3. ICH Q8 – Pharmaceutical Development
4. ICH Q9 – Quality Risk Management
5. ICH Q10 – Pharmaceutical Quality System
6. ICH Q12 – Technical and Regulatory Considerations for Pharmaceutical Lifecycle Management

Learners may take courses individually or as a bundled certificate pathway. Successful completion of all modules results in the Regulatory CMC Essentials Certificate.

Course Curriculum

Who Should Enroll

This program is designed for:

• Quality professionals seeking stronger regulatory context
• Regulatory Affairs (CMC) staff or those transitioning into CMC roles
• Manufacturing, operations, and technical staff needing regulatory understanding
• Process development and tech transfer specialists
• Early career scientists and engineers entering pharmaceutical development or manufacturing
• Professionals in CDMOs, CMOs, and suppliers supporting regulated operations

Program Benefits

• Strengthens regulatory literacy across the pharmaceutical quality lifecycle
• Enhances cross functional communication between QA, Regulatory, Development, and Operations
• Provides a globally recognized regulatory foundation applicable to FDA, EMA, PIC/S, and other health authority expectations
• Offers a stackable, career advancing credential for professionals in the life sciences industry

Pricing

Now Your Whole Team Can Participate in an ISPE Learning Experience

• 3 - 5 participants - Save 10%
• 6 - or more participants - Save 20%

Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, ask@ispe.org.

Cancellations/Refunds

Cancellations must be made in writing. If cancellations are received by 60 days prior to event start date, a full refund, minus a $150 handling fee, will be issued. After that time, no refunds will be granted. Please be advised that if your payment or written cancellation notice is not received prior to the cancellation date, your credit card will be charged the prevailing rate. Refund requests must be in writing and emailed or faxed to +1 (813)-264-2816. (Telephone messages are not accepted). ISPE reserves the right to modify the material or presenters for this event without notice, or cancel an event. If an event must be canceled, registrants will be notified by ISPE. ISPE will not be responsible for airfare penalties or other costs incurred due to cancellation.

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For an enhanced learning experience, ISPE also offers these learning activities as live courses and gives you an opportunity to learn with a live instructor, ask questions, and participate in exercises. View Upcoming Courses