Quality Risk Management – Quality System and Process

Principles of Quality Risk Management (QRM) mandate the assessment of risks to patient safety and product quality grounded in scientific knowledge, data, and experience. Regulatory expectations dictate that QRM is intricately integrated into the core of the Quality Management System (QMS), employing a lifecycle approach to implement both formal and informal risk tools. These tools align with the elements outlined in ICH Q9, encompassing risk assessment, risk control, risk review, communication of identified risks, and acceptance of residual risks. This advanced and interactive training utilizes case studies to offer practical tools and techniques, enabling participants to address current challenges through the application of QRM principles. The program also provides hands-on experience in preparing for and facilitating risk assessments.

Day 1 - Risk Management for Quality System Compliance

Within a Quality System (QS), the ability to make sound decisions based on facts and good science is key to being compliant with the regulatory requirements as well as being economical to the business. Whether it is tracking customer complaints, identifying non-conforming materials or products, managing audit findings, or implementing appropriate corrective and preventive actions (CAPA), having a well understood and integrated Risk Assessment process in place can improve product quality and regulatory or GxP compliance, and reduce legal liability. This training is designed to provide you with relevant knowledge and skills to effectively participate in quality and compliance-related risk assessments. It will provide you with a general understanding of quality systems and processes, as well as an understanding of the Risk Assessment Process that provides the basis from which to conduct a structured risk evaluation.

Day 1 Content

• Quality Risk Management Framework
• The goal of risk management in managing GMP compliance
• The key systems – how they integrate and where risk assessment can be applied to appropriate sub-systems, such as:
  • Auditing
  • Change Control
  • Product Complaints and Adverse Drug Events (ADEs)
  • Deviation Investigation
  • CAPA

Day 2 - Risk Management for Process

Quality Risk Management (QRM) was introduced to the GMPs in 2009 and should now be an integrated part of your daily pharmaceutical manufacturing operations…but is it? Do you know which QRM tool to use in different situations? Are you satisfied that the time and effort in conducting risk assessments is adding real value to your business? Are you confident that your risk evaluation has identified the appropriate level of manufacturing controls? This training can help by providing you with relevant knowledge and skills to effectively participate in process risk assessments. You will gain a general understanding of manufacturing processes and how they are controlled, as well as an understanding of the Risk Assessment Process to ensure you have a basis from which to conduct a structured risk evaluation.

Day 2 Content

• Manufacturing considerations: what can go wrong, complex processes and systems
• Overview of the Quality Risk Management Process
• GMP requirements for risk assessments
• The Quality Risk Management Toolbox: what to use and when
• Conducting Process Risk Assessments, considering:
  • Preliminary Hazard Analysis (PHA)
  • Hazard Analysis and Critical Control Points (HACCP)
  • Failure Mode and Effects Analysis (FMEA)

Participants

This course is designed for both personnel new to process risk assessment as well as more experienced QRM practitioners. You will benefit from this course if you have a simple interest in or have any level of responsibility for risk assessments of quality compliance and/or manufacturing processes.

Format and Course Length

The course will be delivered as an online virtual-classroom training session.

Participants will be provided with a PDF of the training material in advance of the training should they wish to print and annotate notes. Participants will be connected to the trainer and other participants via online collaboration tool Zoom with connected video (webcam / screen sharing) and audio (computer audio or phone dial-in). Theory will be delivered by the trainer sharing their screen of the PowerPoint presentation. Facilitated workshops will be run in digital breakout rooms (e.g. a group of 12 might split into 4 breakout rooms each with 3 participants to separately work on a problem). Breakout rooms can call the trainer in for support when required and the trainer can electronically bring everyone back to the main session to debrief when appropriate.

The training will be delivered as 2 full day sessions with breaks.

PDF Certificates will be provided to participants electronically.

What Do I Need?

Participant needs are very basic. You will need a computer or suitable device with a good internet connection. A headset (headphones with microphone) and second monitor/screen are recommended but not required.

Sessions

Times are based on Singapore time (SGT): UTC +8:00.

Participants to join at 8:45am in advance of a 9:00am start to address any technical issues.

Fee

• SGD $1400 (excluding tax) per participant
  • A 10% discount applies to 3 or more participants from the same company

Course Registration and Payment

To register, please contact Biju Kishor at biju.kishor@seerpharma.com.au 

Contact us to discuss your interest in a public or private delivery of this course.

Refer to the Terms and Conditions