Aims and Objectives
Quality Risk Management is now at the cutting edge of the Life Sciences industry internationally. Recently, the ICH Q9 Guideline on Quality Risk Management (QRM) was incorporated as GMP Annex 20 by the MHRA, PIC/S and the EMEA. GMP Annex 11 is also currently under revision to include a clear reference to a risk-based approach for determining the level of validation.
Regulators expect that pharmaceutical professionals use risk management techniques and tools to manage product quality, manufacturing processes, validation and compliance within a risk based Quality Management System. SeerPharma presents this highly interactive, hands on course on how to apply risk management principles and tools.
The course consists of a lively mix of presentations, group exercises, and discussions. At the end of the course, there will be a short quiz to test understanding. Copies of all presentation slides and handouts will be provided.
Who Should Attend
The course is designed to service a wide range of participants from various disciplines within the pharmaceutical industry. Typically participants will be managers or supervisors who have experiences in a GMP related environment and need to QRM to perform in their current position. Participants wishing to enhance their professional development and advancement in Pharmaceutical management are particularly encouraged to apply.
This course is specifically designed for participants who have prior knowledge in GMP compliance, Quality Assurance, Validation or Product Development practices or those considering working in the pharmaceutical or biotechnology sectors. You should enroll if you have an interest in:
- Quality Assurance
- Production Operations
- GMP Compliance and Auditing
- Validation
- Technical Services
Learning Objectives
Upon completion of this course, participants will have gained an understanding of the current trends and changes in GMPs both within Australia and Internationally. Participants will learn through interactive presentations, case studies and group activities specifically designed for optimum learning. On completion of this course, participants 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
Course Content
This subject consists of four modules or topics:
Day #1 – Application of Risk Management to Quality Systems and Compliance
ICH Q9 is now included in the GMPs as Annex 20. Annex 20 is currently voluntary, however Clauses 1.5 and 1.6 of the revised Australian Code of GMP relate to Quality Risk Management (QRM), and are mandatory. This module introduces an approach for the implementation of risk management to GxP compliance programs. The module explains the concepts within ICH Q9 – Quality Risk Management Guidance and provides guidelines 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.
Day #1 - 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 FMEA tools can be useful for analysing product design risks, but 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.
Day #2 – 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 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.
Day #2 - Applying Risk Management to Validation
Validation is a key element is any life sciences manufacturing operation. It is mandated by all international cGMPs and is regularly reviewed as part of a regulatory audit and often required for product submissions. Validation is however time consuming and often expensive to conduct. A new paradigm, based on the ASTM E2500 standard and the recent FDA draft 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.
