96064 Risk Management for Pharmaceutical Operations
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Subject handbook information prior to 2019 is available in the Archives.
Credit points: 6 cp
Result type: Grade and marks
There are course requisites for this subject. See access conditions.
Description
This is a foundation subject in the Master of Good Manufacturing Practice (GMP). This subject introduces the key principles and functions of compliance for an organisation, describes what a compliance program consists of and how to set up a company program. The subject introduces the key principles and risk models for the introduction of a risk management program into regulated life sciences organisations. The requirements of AS4360 – Risk Management are reviewed. The subject also provides guidance on how risk management practices are used to support compliance programs.
Subject learning objectives (SLOs)
| 079. | Apply appropriate risk evaluation and risk management strategies for GMP compliance |
|---|---|
| 080. | Apply given risk management tools to analyse and control risks |
| 081. | Conduct risk assessment and control using the principles and theories of risk management to manage risks in selected case studies |
| 082. | Evaluate compliance measures against acceptable risk |
| 083. | Evaluate the application of risk analysis and risk management to quality management systems and processes |
| 084. | Explain Quality by Design ? Risk analysis in design and development of products |
| 085. | Explain regulatory guidance for applying risk management in pharmaceuticals ? FDA, EU/PICs/TGA, ICH |
| 086. | Prioritise actions for risk management through qualitative and quantitative evaluation tools |
Course intended learning outcomes (CILOs)
The learning outcomes for this subject are as follows:
- Reflect on the knowledge, skills and attributes required for the evaluation and integration of emerging evidence into practice, promoting the growth of personal and professional learning, and the education of others. (01.09)
- Demonstrate accurate and comprehensive knowledge of risk management practices and models, and implement and evaluate them in a range of contexts. (02.01)
- Test, audit and validate pharmaceuticals manufacturing and distribution processes using appropriate methodologies. (02.02)
- Design, implement and evaluate control systems for pharmaceuticals manufacturing. (02.03)
- Demonstrate ethically and legally accountable approaches to pharmaceuticals manufacturing and control. (02.04)
- Analyse and synthesise knowledge of relevant concepts and theory, and apply skills of scientific research and reasoning to support Good Manufacturing Practice. (02.05)
- Produce accurate technical documentation, and communicate effectively and accurately with clients and stakeholders in written or spoken language appropriate to their needs. (02.06)
- Demonstrate knowledge of Good Manufacturing Practice in local, national and global contexts. (03.11)
Contribution to the development of graduate attributes
Here students become familiar with the skills and knowledge necessary to apply Risk Management principles to ensure quality manufacturing, packaging and management of pharmaceutical operations.
Thus in 96064 students progress towards achievement of the course's Lifelong Learning, Professional Capacity and Global Citizenship graduate attributes.
Lifelong Learning:
Graduates of the Master of GMP are lifelong learners, committed to and capable of reflection and inquiry in their quest for personal development and excellence in professional practice.
Professional Capacity:
Graduates of the Master of GMP are industry-focused, ethical practitioners with the understanding and proficiency to be leaders in their profession, capable of effectively analysing and implementing solutions in a global context under international regulatory guidelines.
Global Citizenship:
Graduates of the Master of Good Manufacturing Practice contribute to society, resolving to undertake those actions and responsibilities that will enhance their role in local, national and global communities.
Teaching and learning strategies
On Campus Mode
This subject is delivered on the City campus and requires attendance for three face-to-face contact hours per week.
Students will learn in this Subject through online content comprising videos, set reading, directed research, activities and self-check quizzes. This independent learning will be supported by group learning experiences, in which ideas and concepts can be tested and refined. Workshops are held to provide an opportunity to apply online content to simulated real life pharmaceutical industry situations.
Students will start learning about the regulatory requirements for risk management. With a fundamental understanding of risk management principles, this subject will elaborate on the identification, analysis and management of risks in the manufacturing processes to ensure pharmaceutical products that are safe, pure and effective. Specifically, students will follow a top-down process from planning to risk management, using risk management tools such as Hazard Analysis and Critical Control Point (HACCP) and Failure Mode and Effects Analysis (FMEA) to address and control risks. The concept of Quality by Design (QbD) is introduced to emphasise the importance of designing quality into a pharmaceutical product while in the early R&D phases and continue with process inprovemnet as manufacturing knowledge is established.
Strategy 1: Student preparation for learning: Students read articles and use online resources, such as online course material, videos, directed research, activities, self-check quizzes and case studies, provided via Canvas. Students prepare for their participation in activities such as facilitated discussion of solutions to industry case studies, assessable end of module quizzes, and collaborative discussion of fundamental concepts drawn from online content and international regulatory guidelines and practices. This preparation lays the foundation for application of this understanding in collaborative workshops.
Strategy 2: Collaborative and interactive learning in workshops: Workshops provide students with an opportunity to discuss and clarify concepts from the online content, thus providing the students the opportunity for deeper understanding. Each workshop aims to apply online content in real life pharmaceutical industry scenarios and collaboration with fellow students is encouraged. Students will engage in group discussions and problem solving. There will be 2 hours of workshop each week.
Strategy 3: Early and consistent feedback: Early feedback is provided face to face prior to the census date during class discussions and workshops. Feedback regarding the quizzes is provided following each quiz, via provision of answers and/or in-class review. The collaborative learning approach utilised in class will enable ongoing feedback to be provided in class, as areas of learning need are identified through class discussions. Students will make use of the feedback received to improve on their next assessment. In particular the two-part assessment in this subject enables students to utilize feedback directly in preparation of the second part of the assessment.
Strategy 4: Group work: students work in groups during workshop sessions. Students will need to coordinate group work, fostering negotiation, team building and teamwork skills, and respect for diverse ways of working.
Strategy 5: Students are encouraged to critically reflect on their learning throughout the subject to identify areas where they may improve their performance and develop lifelong learning skills.
Online Mode
This subject is delivered online and does not require on campus attendance.
Students will learn in this Subject through online content comprising videos, set reading, directed research, activities and self-check quizzes. This independent learning will be supported by group learning experiences using online discussions, in which ideas and concepts can be tested and refined. In addition, online students will have regular access to the class teacher.
Students will start learning about the regulatory requirements for risk management. With a fundamental understanding of risk management principles, this subject will elaborate on the identification, analysis and management of risks in the manufacturing processes to ensure pharmaceutical products that are safe, pure and effective. Specifically, students will follow a top-down process from planning to risk management, using risk management tools such as Hazard Analysis and Critical Control Point (HACCP) and Failure Mode and Effects Analysis (FMEA) to address and control risks. The concept of Quality by Design (QbD) is introduced to emphasise the importance of designing quality into a pharmaceutical product while in the early R&D phases and continue with process inprovemnet as manufacturing knowledge is established.
Strategy 1: Student directed learning: Students read articles and use online resources, such as online course material, videos, directed research, activities, self-check quizzes and case studies, provided via Canvas. Self directed learning prepares students for participation in activities such as facilitated discussion of solutions to industry case studies, and collaborative online discussion of fundamental concepts drawn from course material and international regulatory guidelines and practices.
Strategy 2: Online discussion forums: These discussion forums provide students with an opportunity to discuss and clarify concepts from the study material provided online, thus providing the students the opportunity for deeper understanding. Each online discussion aims to apply course material in real life pharmaceutical industry scenarios and collaboration with fellow students is required by posting and responding to other students’ posts in the discussion forum. Students participate in the online discussions by writing their comments in the Canvas platform in their own time and also read and respond to posts from peers. Each discussion has an end time designated by which students must have contributed.
Strategy 3: Early and consistent feedback: Early feedback is provided prior to the census date during ‘open office’ hours and discussion forums. Feedback regarding the self-check quizzes is provided via Canvas immediately upon submission of each quiz .The collaborative learning approach will enable ongoing feedback to be provided to students, via teacher responses to posts, as areas of learning need are identified through online discussions. Students will make use of the feedback received to improve on their next assessment. In particular the two-part assessment in this subject enables students to utilize feedback directly in preparation of the second part of the assessment.
Strategy 4: Collaborative work: students work collaboratively through online discussions. Students will need to respond respectfully and constructively to their peers' posts fostering communication, constructive criticism and respect for diverse ways of working.
Strategy 5: Students are encouraged to critically reflect on their learning throughout the subject to identify areas where they may improve their performance and develop lifelong learning skills.
Subject Delivery: This subject is delivered entirely online in the Canvas Learning Management System.
Content (topics)
Within the broad context of risk management, you will initially learn about the regulatory requirements to ensure pharmaceutical product safety and effectiveness. You will learn about the risk management tools used. Case studies are presented where students develop skills to identify, analyse and control risks. Students also learn to assess and prioritise risk management in accordance with product safety characteristics and process complexities.
Assessment
Assessment task 1: On-going Graded Assessment
| Intent: | Throughout the semester student will have the opportunity to check their understanding of the course content via graded assessments through the Canvas platform. |
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| Objective(s): | This task is aligned with the following subject learning objectives: 079, 080, 081, 082, 083, 084, 085 and 086 This task is aligned with the following course learning outcomes: 02.01, 02.02, 02.03, 02.04, 02.05 and 03.11 |
| Groupwork: | Individual |
| Weight: | 15% |
| Criteria: | Tasks are marked by the lecturer according to the specific requirements of each task. The tasks are designed to allow assessment of the student’s ability to apply and evaluate the principles learned. |
Assessment task 2: Risk Assessment in Pharmaceutical Manufacturing
| Intent: | This assignment is designed for you to show how you can apply the risk management tools in GMP. Through this assignment you will experience the importance of evaluating risks in pharmaceutical manufacturing and the implementation of appropriate controls to ensure products are safe, effective and pure. |
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| Objective(s): | This task is aligned with the following subject learning objectives: 079, 080, 081, 083 and 085 This task is aligned with the following course learning outcomes: 01.09, 02.01, 02.03, 02.04, 02.05, 02.06 and 03.11 |
| Type: | Report |
| Groupwork: | Individual |
| Weight: | 20% |
| Length: | Approximately 1500 words, excluding references |
| Criteria: | Provided via Canvas in the Assignments menu |
Assessment task 3: Case Study - Risk Management Assignment
| Intent: | This assignment is designed for you to demonstrate further understanding about how to apply risk assessment and management in pharmaceutical design and manufacturing processes. The risk assessment and management aspects extend through the lifecycle of pharmaceutical products. You will show your understanding of the concept of Quality by Design (QbD). |
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| Objective(s): | This task is aligned with the following subject learning objectives: 079, 080, 081, 082, 083, 084, 085 and 086 This task is aligned with the following course learning outcomes: 01.09, 02.01, 02.02, 02.03, 02.04, 02.05, 02.06 and 03.11 |
| Type: | Report |
| Groupwork: | Individual |
| Weight: | 30% |
| Length: | Approximately 1500 words, excluding references |
| Criteria: | Provided via Canvas in the Assignments menu |
Assessment task 4: Final Examination
| Intent: | This final exam is for you to show how to analyse risks associated with manufacturing processes, and to overcome these risks through controls and validations. You will demonstrate your knowledge by providing and explaining a risk management master plan for pharmaceutical products. |
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| Objective(s): | This task is aligned with the following subject learning objectives: 079, 080, 081, 082, 083, 084, 085 and 086 This task is aligned with the following course learning outcomes: 01.09, 02.01, 02.02, 02.03, 02.04, 02.05, 02.06 and 03.11 |
| Type: | Examination |
| Groupwork: | Individual |
| Weight: | 35% |
| Length: | 1 hour and 40 mins; including 10 minutes of reading time |
| Criteria: | Provided via Canvas in the Assignments menu |
Minimum requirements
On Campus Mode
In order to pass this Subject, a minimum grade of 50% must be achieved.
Students are required to attend a minimum of 85% of classes, and submit all assessment tasks
Online Mode
In order to pass this Subject, a minimum grade of 50% must be achieved and students must submit all assessment tasks.
Required texts
Provided via the Canvas site
Coursework Assessments Procedures
Graduate School of Health Policy, Guidelines and Procedures (login required)
Recommended texts
ICH Q9 – Quality Risk Management
ASTM E55.03 (Draft) (WK9864) Standard Guide for Science and a Risk Based Approach to Qualification of Biopharmaceutical and Pharmaceutical Manufacturing Systems)
EU/PICs/TGA cGMP – Annex 15 Qualification and Validation*
FDA Guidance for Industry Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations*
ICH Q8 – Pharmaceutical Development* ICH Q10 – Quality Management Systems*
ANSI/AAMI/ISO Standard 13485:2003 Medical devices – Quality Management Systems – requirements for regulatory practices
ISO 14971:2000 – Application of Risk Management to Medical Devices
Other relevant references as identified throughout course notes and workshops.
