Quality Risk Management (QRM) is a mandatory regulatory requirement for pharmaceutical manufacturing organisations.
The ICH Q9 guideline on Quality Risk Management (Annex 20 of the PIC/S GMP Guide) is now expected to be adopted by manufacturers to ensure compliance with clauses 1.12 and 1.13 of Part I of the PIC/S Guide to GMP:
1.12 Quality Risk Management is a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. It can be applied both proactively and retrospectively.
1.13 The principles of Quality Risk Management are that:
(i) The evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient;
(ii) The level of effort, formality and documentation of the Quality Risk Management process is commensurate with the level of risk.
You must have a comprehensively designed and correctly implemented Pharmaceutical Quality System (PQS) incorporating Good Manufacturing Practice (GMP) and Quality Risk Management (QRM). The QRM elements of your quality system will drive decision-making.
SeerPharma presents this highly interactive, hands-on course that will show you how to apply risk management principles, techniques and tools to real-life situations.
The course is designed to service a wide range of participants from various disciplines within the pharmaceutical industry and particularly managers or supervisors with experience in GMP (e.g. Production, Quality Assurance (QA), Validation, Technical Services) who need to apply Quality Risk Management (QRM) in their role. Alternatively, you may be looking for professional development to enhance your opportunities of securing a more senior position.
You will gain an understanding of the current trends and changes in GMPs within Australia and Internationally. You will learn through interactive presentations, case studies and group activities specifically designed for optimum learning and on completion of the course you will be able to:
- Apply QRM to company GMP compliance and audit programs
- Evaluate the principles and apply the practices of risk management in pharmaceutical operations
- Make sound judgments based on risk management principles
- Utilise risk evaluation techniques to analysis pharmaceutical products, operations and systems
- Propose control strategies and plans to mitigate unacceptable compliance risks
- Apply risk based principles to validation programs
This course consists of four modules or topics:
1 – Application of Risk Management to Quality Systems and Compliance
This module introduces an approach for the implementation of risk management to GxP compliance programs, explaining the concepts within ICH Q9 – Quality Risk Management Guideline – and providing advice on how to audit compliance using risk-based principles. The module also provides guidance on how risk management practices are used to support compliance programs and uses an industry case study as an example.
2 – Applying Practical Risk Management Tools
ICH Q9/Annex 20 makes recommendations concerning the appropriate use of risk management tools. Generally there are a number of alternate approaches to development of risk profiles and different tools are applicable to different situations. For example, Failure Modes Effects Analysis (FMEA) tools can be useful for analysing product design risks, but Hazard Analysis and Critical Control Point (HACCP) tools may be best for process risk analysis. Knowing when to apply qualitative or quantitative analyses is an important skill to master. This module describes a number of different tools that may be applicable to risk management for risk identification, risk assessment, risk control and post-market feedback.
3 – Applying Risk Management to Product and Process Design
This module expands on the role of design control and application of risk management in the design and development of life sciences products. The concepts within ICH Q8(R2) – Pharmaceutical Development Guideline – and the principles within CFR 820.30 (design control) will be presented along with an illustrative case study on how to use risk assessment in design and development. HACCP techniques are also presented as a means to evaluate the risks associated with processes and unit operations. The module illustrates the application of risk management to product and process design using practical examples and case studies.
4 – Applying Risk Management to Validation
Validation is a key element in any life sciences manufacturing operation. It is mandated by all international cGMPs and is regularly reviewed as part of a regulatory inspection and often required for product submissions. Validation is however time consuming and often expensive to conduct. A newer paradigm, based on the ASTM E2500 standard and the FDA guidance for process validation is presented. This module also presents specific risk assessment techniques applicable to equipment qualification and process validation. Case studies and specific techniques such as process mapping are included.
Format and Course Length:
The 2-day course involves a lively mix of case studies / workshops and intensive tutorial sessions. The delivery method is collaborative with a small group and facilitator, which has been shown to enhance learning and critical thinking skills of participants. You will receive copies of all presentation slides and a Certificate.
Scheduled sessions run from 9am to 5pm unless otherwise specified.
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