ICH Q6A: Specifications, Test Procedures, and Acceptance Criteria for New Drug Substances and Products
Delivery Mode: Webinar
This course covers testing and quality control requirements in marketing authorization/new drug applications, emphasizing ICH guidelines. It focuses on ICH Q6A, detailing test procedures and acceptance criteria for new drug substances/products to ensure global consistency and safety. The course also integrates later guidelines (ICH Q8, Q9, Q10, Q11), introducing science and risk-based approaches. Participants will learn to navigate global marketing authorization/new drug applications, contributing to high-quality pharmaceutical product development.
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.
Included in the QC Lab Testing Fundamentals Certificate Program
The QC Lab Testing Fundamentals Certificate Program develops foundational competency for professionals who support quality control (QC) laboratory operations in GMP environments. Blending ISPE’s GMP essentials with practical QC laboratory skills and ICH recommendations, the program strengthens the knowledge needed to generate reliable data, make sound release decisions, and sustain inspection-ready performance across the product lifecycle. Learn More and Register
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
Registration Fee
| Member | Nonmember |
|---|---|
| US$270 | US$300 |