The ICH Q8 guideline ensures a systematic approach to pharmaceutical development by defining globally recognized Quality by Design (QbD) principles to enhance product quality throughout all stages of development.
This course provides a comprehensive overview of Quality by Design (QbD), emphasizing its science-and-risk-based methodology with a patient-centric focus specifically tailored to enhance manufacturing processes. Participants will gain a thorough understanding of QbD terminology, key steps, and the advantages it offers. Additionally, it covers regulatory and industry guidelines, offering valuable insights into linking QbD with the Process Validation lifecycle, including references to influential resources such as the ISPE PQLI Guides.
Included in the Regulatory CMC Essentials Certificate Program
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. Learn More and Register
Course Modules/Learning Objectives
Foundations of ICH Q8 and Quality by Design (QbD)
Core Concepts and Terminology QTPP and CQAs
Understanding CPPs and CMAs
Main DoE Example - Dissolution Response Surface
Analysis Risk Assessment using FMECA
Control Strategy
Process Validation
Continuous Improvement
Interactive Course includes:
Immersive Videos
Engaging graphics
Reference materials and links to regulatory information
Assessments to measure your comprehension
The ability to start and stop at any time, beginning where you left off
CEUs are provided once you achieve an 80% passing grade and complete the evaluation.
The course is self-paced. On average, the time required for completion ranges from 1 to 3 hours.
Gain the knowledge and competitive edge you need to succeed in the pharmaceutical and biopharmaceutical engineering industries and join more than 18,000 pharma professionals from around the world by becoming an ISPE Member.
Benefits include:
Online access to select ISPE Good Practice Guides that will help you learn how to practically implement best practices and principles
Member-only discounts on Guidance Documents, Conferences, and Training
Pharmaceutical Engineering® magazine
Communities of Practice access to pharma professionals in specific topics from around the world
ISPE training is priced using Global Access Pricing, a four-tier model designed to reflect what a course actually costs in your country, not just what the US price converts to.
Because course fees vary, tiered rates are applied as a percentage of the standard US price. Your rate is calculated automatically at registration based on your country, and applies to both member and non-member pricing.
Tier
Member
Non-member
Tier 1
Standard pricing
Standard pricing
Tier 2
US$ 620
US$ 805
Tier 3
US$ 454
US$ 575
Tier 4
US$ 300
US$ 345
Example: Rates shown are based on a course listed at US$ 2,000 for members and US$ 2,300 for non-members. Actual amounts vary by course.
