Annex 20 – Quality Risk Management & ICH Q9 (R1)

Description

PIC/S Annex 20 – Quality Risk Management (QRM) guidelines and ICH Q9 (R1)

• PIC/S Annex 20 covers Quality Risk Management (QRM) requirements for GMP compliance
• This course will help you understand your QRM requirements for quality risk management (QRM) including QRM processes, risk assessment tools, integration with your PQS, and risk controls.
• Topics include the identification of potential hazards, risk analysis/risk assessment requirements, approval criteria, and related Regulatory Authority expectations for managing risks to quality (throughout the product’s lifecycle).
• It includes information on the latest ICH Q9 (R1) guidelines (ICH Q9 was recently updated).

This interactive GMP e-Learning course on PIC/S Annex 20 & ICH Q9 (R1) gives the GMP course participant an understanding of Quality Risk Management (QRM) within the pharmaceutical industry.

It covers principles of Quality Risk Management and the importance of hazard identification and risk assessments, risk management processes, risk assessment tools, and related controls.

About this Quality Risk Management training course:

This online cGMP/GMP course is based on guidance in PIC/S Annex 20 and ICH Q9 (R1), (recently updated), two key standards with which compliance is expected by Regulatory Authorities.

Learning objectives

The objectives of this training module are:

• to learn the importance of quality risk management processes and quality risk assessment tools in the manufacture of medicinal products
• to understand the quality risk management process and organisational requirements
• to learn what is generally expected by Regulatory Authorities in terms of formality of quality risk management procedures and documentation
• to review requirements for applying QRM to supply chains/supply chain protections (to ensure product availability for patients)
• to recognise that QRM continues throughout the product lifecycle

Who should take this PIC/S Annex 20 & ICH Q9 (R1) Quality Risk Management course?

This course is suitable for senior management members, Quality Management team members, production managers, business owners, operating personnel and pharmaceutical engineering personnel.

Certificate GMP eLearning Course

After successfully completing this course, GMP course attendees will have the option of printing or saving a personalised training certificate that meets regulatory GMP requirements.

Course duration: Allow 1 to 1.5 hours to complete this course.