Quality Management Systems

ICH Q7: API Guidelines

The ICH Q7 guideline ensures consistent quality and safety in the production of Active Pharmaceutical Ingredients (APIs) by defining globally recognized Good Manufacturing Practices (GMP) for all stages of API manufacturing.

ICH Q8: QbD in Manufacturing

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.

ICH Q10: Pharmaceutical Quality System (PQS)

The Pharmaceutical Quality System (PQS), as defined by ICH Q10, ensures product quality and continuous improvement throughout the lifecycle of pharmaceutical products. Overview This fundamental online course introduces the Pharmaceutical Quality System (PQS), which is a framework that ensures...

ICH Q9(R1): Guidelines on Pharmaceutical Risk Management

Delivery Mode: Webinar An introduction to the ICH Q9(R1): Guidelines on Pharmaceutical Risk Management. This lesson covers the fundamentals for assessing and mitigating risks during drug product lifecycles and incorporates the latest requirements from ICH Q9(R1), which was updated in 2023, and...

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...

Advancing Pharmaceutical Quality™ (APQ) Quality Management Maturity Training Course (T74)

The ISPE Advancing Pharmaceutical Quality™ (APQ) Program has been developed by industry representatives, for industry use, to provide a practical framework that organizations can use to assess and advance the state of quality within their organization. The APQ program recognizes that the ability to....

CAPA / RCA / Investigations Training Course (T73)

Coming Soon 2024 - CAPA and Continuous Improvement using Process Performance & Product Quality Monitoring (PPPQMS), are elements of the Pharmaceutical Quality System (PQS), supported by ICH Q10. By practicing effective CAPA and PPPQMS a Pharmaceutical Quality System can realize Quality Management....

Implementation of ICH Q12 Guideline

Delivery Mode: Webinar ISPE Team Assists Training Health Canada with Implementation of ICH Q12 Guideline, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Regulatory Background International Council for Harmonisation’s (ICH) guideline entitled, “Technical and...

Quality Management Systems Training Course (T57)

Through lecture and group exercises this course illustrates how quality systems work, the purpose of the different elements, how they connect to each other and how to recognize and transfer knowledge/connectivity throughout the organization. The diagram below from ICH Q10, covers the product life....