Quality Management Systems in Biotechnology (BIOT3009)

Course overview

This course will provide students with a comprehensive introduction to the shared principles of all quality management systems used within the biotechnology sector and beyond. It will then focus on critical quality standards encountered along the pathway to commercialisation for biotechnology / pharmaceutical products.

BIOT3009: Course Introduction

Biotechnology involves the use of biology to develop new products, methods and organisms intended to improve human health and society. It is multidisciplinary and is applied in areas as diverse as healthcare, agriculture, industry and the environment. Biotechnology products have the potential to directly impact human health and so it is absolutely critical to ensure the safety of these products. This is typically achieved through the application of strict regulatory requirements, overseen by relevant government authorities.

In order to achieve regulatory compliance, organisations implement a Quality Management System (QMS). This is a formalised system that documents processes, procedures and responsibilities for achieving quality policies and objectives. It is extremely important to recognise, at the outset, that a QMS is not simply a compliance tool. Utilised well, it can also drive consistency and reproducibility, increase cost efficiency, build customer trust, help mitigate risks, provide a competitive advantage and assist in the protection of intellectual property.

From small start-ups to large-scale, multinational organisations, a QMS is integral to every aspect of a biotech company's operations, from research and development to manufacturing and distribution. It helps ensure that products are safe, effective, and compliant with regulations and, ultimately, contributes to the company's success and its ability to deliver innovative solutions to address both today’s issues and tomorrow’s challenges.

Part 1: Course Introduction Lecture & Workshop (Week 1)

An overarching introduction to the course will be provided to students. This will provide an excellent opportunity to clarify course details, highlight critical dates and outline expectations. It will also allow any initial student questions to be addressed.

Part 2: General Quality Management Systems Lectures & Workshops (Weeks 2-6)

Students are provided with a comprehensive overview of the shared elements of all modern quality management systems (regardless of the field of application). Every lecture will be complemented by a fun, interactive and engaging workshop which allows the introduced GQMS concepts / ideas to be further developed, explored and applied within a contemporary setting.

Part 3: GxP Lectures & Workshops (Weeks 7-12)

Students will then build on these General Quality Management System concepts as they journey through some of the key quality standards encountered when taking products to market. This includes a detailed review of:

• GLP (Good Laboratory Practice) – Safety / Toxicology Studies (Pre-Clinical)
• GCP (Good Clinical Practice) – Human Studies (Clinical)
• GMP (Good Manufacturing Practice) – Manufacture of Products

Each GxP module will be deliveredﾠby industry experts familiar with the current expectations of both Sponsors and Regulatory Authorities. Workshops will be based on ‘real-life’ scenarios and, upon completion, it is expected that students will have a comprehensive understanding of the realities and practicalities of operating within a current GxP environment.ﾠﾠ

Part 4: GMOs / OGTR, Accreditation vs Certification Lecture (Week 13)

In this section, students will be introduced to the governance relating to Genetically Modified Organisms (GMOs) and the role of the Office of Gene Technology (OGTR) in regulating GMOs. Students will also be provided with a brief look at the key differences between accreditation and certification and other international standards they may encounter within a biotechnology context (e.g. ISO 13485 – Medical Devices).

Part 5: Site Visits (Dates to be confirmed)

Students will have the opportunity to visit organisations working under various quality management systems. Whilst these activities are optional (and not assessed), they are strongly encouraged as they will provide an excellent opportunity to observe the real-life implementation of the concepts covered in the course whilst also exposing students to the actual work undertaken by these companies.

Provisional dates are as follows:

Site Visit 1 = Week 5

Site Visit 2= Week 8

Site Visit 3 = Week 12

Note: Numbers may be limited for site visits and not all students will be able to attend every site visit.

Part 6: Quality Reflections (Date to be confirmed)

Students will have the opportunity to attend a seminar at St Lucia and learn from UQ Biotech graduates who have gained experience working under quality management systems. Whilst this activity is optional (and not assessed), attendance is strongly encouraged as it will provide an outstanding opportunity to link the theory of quality management systems with the everyday realities / practicalities of working under one.

Part 7: Undergraduate Tutorials (Provisionally Weeks 4, 7 & 9)

These will provide undergraduates with an additional opportunity to discuss / explore course content. They are optional and not assessed but attendance is strongly recommended.

Course Benefits:

This course represents an outstanding opportunity to understand how incredible scientific discoveries are transformed into commercially available products that have satisfied regulatory requirements. It is anticipated that students graduating from this course will possess a practical and competitive advantage when embarking on their own careers, whether it be in the development of biotech products or within any other regulated industries.

Course requirements

Recommended prerequisites

We recommend completing the following courses before enrolling in this one:

BIOT2002

Incompatible

You can't enrol in this course if you've already completed the following:

BIOT7031 (co-taught)

Jointly taught details

This course is jointly-taught with:

Lectures, workshops and assessments may be shared between BIOT7031 (Internal), BIOT7031 (External) & BIOT3009.

Course contact

Course staff

Timetable

The timetable for this course is available on the UQ Public Timetable.

Additional timetable information

Check your online timetable regularly

ﾠ

Aims and outcomes

The aims of this course include:

1. Familiarising students with the shared principles of all quality management systems and confirming they can be confidently applied. This will benefit both students remaining in academia and those transitioning to industry.
2. Outlining critical quality standards encountered along the pathway to commercialisation for biotechnology / pharmaceutical products.
3. Highlighting the importance of quality management systems, not just in terms of ensuring regulatory compliance, but also their role in driving consistency and reproducibility, increasing safety and efficiency, building customer trust, helping mitigate risks, providing a competitive advantage and assisting in the protection of intellectual property.

Learning outcomes

After successfully completing this course you should be able to:

Assessment

Assessment summary

A hurdle is an assessment requirement that must be satisfied in order to receive a specific grade for the course. Check the assessment details for more information about hurdle requirements.

Assessment details

In-Semester Exam

• Hurdle
• Identity Verified
• In-person

Mode

Written

Category

Examination

Weight

25%

Due date

In-semester Saturday

29/03/2025 - 12/04/2025

Other conditions

Time limited.

See the conditions definitions

Learning outcomes

L01, L07

Task description

Hurdle requirements

Exam details

Submission guidelines

Deferral or extension

You may be able to defer this exam.

GLP Study Plan (Group-Based)

• Hurdle
• Team or group-based
• In-person

Mode

Written

Category

Project

Weight

30%

Due date

7/05/2025 2:00 pm

Other conditions

Peer assessment factor.

See the conditions definitions

Learning outcomes

L02, L03, L04, L07

Task description

Hurdle requirements

Submission guidelines

Submission is via Blackboard

Submit through the course Turnitin submission point in Blackboard. Before submitting your assessment item to Turnitin please name your file in the following way. FAMILY NAME_GivenName_StudentID_CourseCode_AssignmentName For example: Bob Smith (ID: 54329876) would name his ABCD1234 essay 1 in the following way. SMITH_Bob_54329876_ABCD1234_Essay1

Deferral or extension

You may be able to apply for an extension.

Applications for Extensions

Information on applying for an extension can be found here: my.UQ Applying for an extension.

Extension applications must be received by the assessment due date and time.

If you are unable to provide approved documentation to support your application by the due date and time, you must still submit your application by the deadline but with an attached Word document that outlines why you cannot provide the approved documentation by the deadline. You will then need to acquire and upload the approved documentation to your request within 24 hours. Please note: When an extension request has been submitted and is pending, students are expected to continue to work on the assessment item, with the aim of submitting by the requested due date and time.

Prolonged Absence

If you have been ill or unable to attend class for more than 14 days, we advise you to carefully consider whether you are capable of successfully completing your courses this semester.

Extensions with Student Access Plans (SAP)

For extensions up to 7 days, your SAP is all that is required as documentation to support your application. However, extension requests longer than 7 days (for any one assessment item) will require the submission of additional supporting documentation e.g. a medical certificate.

Late submission

A penalty of 10% of the maximum possible mark will be deducted per 24 hours from time submission is due for up to 7 days. After 7 days, you will receive a mark of 0.

You are required to submit assessable items on time. If you fail to meet the submission deadline for any assessment item, then 10% of the maximum possible mark for the assessment item (assessment ‘marked from’ value) will be deducted as a late penalty for every day (or part day) late after the due date. For example, if you submit your assignment 1 hour late, you will be penalised 10%; if your assignment is 24.5 hours late, you will be penalised 20% (because it is late by one 24-hour period plus part of another 24-hour period). 10% will be deducted per day for up to 7 calendar days, at which point your submission will receive a mark of zero (0) unless an extension has been approved.

In most instances one or more hurdles will apply to your assessment item so you will need to submit it to fulfil the requirements of the course regardless of how late it is and the mark you are likely to be awarded.

GCP Clinical Protocol (Group-Based)

• Hurdle
• Team or group-based
• In-person

Mode

Written

Category

Project

Weight

30%

Due date

21/05/2025 2:00 pm

Other conditions

Peer assessment factor.

See the conditions definitions

Learning outcomes

L02, L03, L05, L07

Task description

Hurdle requirements

Submission guidelines

Submission is via Blackboard

Submit through the course Turnitin submission point in Blackboard. Before submitting your assessment item to Turnitin please name your file in the following way. FAMILY NAME_GivenName_StudentID_CourseCode_AssignmentName For example: Bob Smith (ID: 54329876) would name his ABCD1234 essay 1 in the following way. SMITH_Bob_54329876_ABCD1234_Essay1

Deferral or extension

You may be able to apply for an extension.

Applications for Extensions

Information on applying for an extension can be found here: my.UQ Applying for an extension.

Extension applications must be received by the assessment due date and time.

If you are unable to provide approved documentation to support your application by the due date and time, you must still submit your application by the deadline but with an attached Word document that outlines why you cannot provide the approved documentation by the deadline. You will then need to acquire and upload the approved documentation to your request within 24 hours. Please note: When an extension request has been submitted and is pending, students are expected to continue to work on the assessment item, with the aim of submitting by the requested due date and time.

Prolonged Absence

If you have been ill or unable to attend class for more than 14 days, we advise you to carefully consider whether you are capable of successfully completing your courses this semester.

Extensions with Student Access Plans (SAP)

For extensions up to 7 days, your SAP is all that is required as documentation to support your application. However, extension requests longer than 7 days (for any one assessment item) will require the submission of additional supporting documentation e.g. a medical certificate.

Late submission

A penalty of 10% of the maximum possible mark will be deducted per 24 hours from time submission is due for up to 7 days. After 7 days, you will receive a mark of 0.

You are required to submit assessable items on time. If you fail to meet the submission deadline for any assessment item, then 10% of the maximum possible mark for the assessment item (assessment ‘marked from’ value) will be deducted as a late penalty for every day (or part day) late after the due date. For example, if you submit your assignment 1 hour late, you will be penalised 10%; if your assignment is 24.5 hours late, you will be penalised 20% (because it is late by one 24-hour period plus part of another 24-hour period). 10% will be deducted per day for up to 7 calendar days, at which point your submission will receive a mark of zero (0) unless an extension has been approved.

In most instances one or more hurdles will apply to your assessment item so you will need to submit it to fulfil the requirements of the course regardless of how late it is and the mark you are likely to be awarded.

Online Quiz

• Hurdle
• Online

Mode

Activity/ Performance

Category

Quiz

Weight

15%

Due date

30/05/2025 2:00 pm

Other conditions

Time limited.

See the conditions definitions

Learning outcomes

L01, L02, L03, L04, L05, L06, L08

Task description

Hurdle requirements

Submission guidelines

Submission is via Blackboard

Deferral or extension

You may be able to apply for an extension.

Applications for Extensions

Information on applying for an extension can be found here: my.UQ Applying for an extension.

Extension applications must be received by the assessment due date and time.

If you are unable to provide approved documentation to support your application by the due date and time, you must still submit your application by the deadline but with an attached Word document that outlines why you cannot provide the approved documentation by the deadline. You will then need to acquire and upload the approved documentation to your request within 24 hours. Please note: When an extension request has been submitted and is pending, students are expected to continue to work on the assessment item, with the aim of submitting by the requested due date and time.

Prolonged Absence

If you have been ill or unable to attend class for more than 14 days, we advise you to carefully consider whether you are capable of successfully completing your courses this semester.

Extensions with Student Access Plans (SAP)

For extensions up to 7 days, your SAP is all that is required as documentation to support your application. However, extension requests longer than 7 days (for any one assessment item) will require the submission of additional supporting documentation e.g. a medical certificate.

Late submission

Late Submission Penalty

For submissions:

• less than 5 minutes late: 5% penalty
• between 5 minutes to less than 15 minutes late: 20% penalty
• more than 15 minutes late: 100% penalty.

Course grading

Full criteria for each grade is available in the Assessment Procedure.

Additional course grading information

Assessment Hurdles

In order to pass this course, you must meet ALL of the following requirements (if you do not meet these requirements, the maximum grade you will receive will be a 3):

1. You must obtain an overall course mark of 50% or more; and
2. You must obtain a minimum weighted average mark of 40% across all other non-examination course assessment items;

Additional course requirement:

1. To receive a grade above 4 you must obtain an overall mark of 40% or more in the in-semester examination.

Supplementary assessment

Supplementary assessment is available for this course.

Should you fail a course with a grade of 3, you may be eligible for supplementary assessment. Refer to my.UQ for information on supplementary assessment and how to apply.

Supplementary assessment provides an additional opportunity to demonstrate you have achieved all the required learning outcomes for a course. 

If you apply and are granted supplementary assessment, the type of supplementary assessment set will consider which learning outcome(s) have not been met. 

Supplementary assessment can take any form (such as a written report, oral presentation, examination or other appropriate assessment) and may test specific learning outcomes tailored to the individual student, or all learning outcomes.

To receive a passing grade of 3S4, you must obtain a mark of 50% or more on the supplementary assessment.

Additional assessment information

Assessment Submission

It is the responsibility of the student to ensure the on time, correct and complete submission of all assessment items.

Students are responsible for retaining evidence of submission by the due date for all assessment items, in the required form (for example, screenshot, email, photo, and an unaltered copy of submitted work).

In the case of a Blackboard outage, contact the Course Coordinator as soon as possible to confirm the outage with ITS.

Assessment/Attendance

Notify your Course Coordinator as soon as you become aware of any issue that may affect your ability to meet the assessment/attendance requirements of the course. The my.UQ website and the Course Profile (CP) for your course provide information about your course requirements, the rules associated with your courses and services offered by the University.

A note for repeating students in this course

Only learning activities and/or assessment items completed during the study period of enrolment, including any approved extensions, may contribute to your grade in this course. The whole or partial use of assessment items previously submitted for the same course, for a course at any institution, or for published material, is not permitted without written permission of the Course Coordinator.

Important Note

Turnitin is to be used for assignments/laboratory reports to check for plagiarism. Penalties can be severe for plagiarism.

The University has adopted the following definition of plagiarism: Plagiarism is the act of misrepresenting as one's own original work the ideas, interpretations, words or creative works of another either intentionally or unintentionally. These include published and unpublished documents, designs, music, sounds, images, photographs, computer codes and ideas gained through working in a group. These ideas, interpretations, words or works may be found in print and/or electronic media.

Students should read the UQ Student Integrity and Misconduct Policy.

Learning resources

You'll need the following resources to successfully complete the course. We've indicated below if you need a personal copy of the reading materials or your own item.

Library resources

Library resources are available on the UQ Library website.

Additional learning resources information

Blackboard

Lecture notes and other learning resources will be provided via the BIOT3009/BIOT7031 Blackboard site at learn.uq.edu.auﾠand/or distributed at the lectures. For copyright reasons access to lecture material is restricted to enrolled students. You will be required to enter your USERNAME and PASSWORD for access.

Please check the Announcements section of the Blackboard site regularly for information updates.

Learning activities

The learning activities for this course are outlined below. Learn more about the learning outcomes that apply to this course.

Policies and procedures

University policies and procedures apply to all aspects of student life. As a UQ student, you must comply with University-wide and program-specific requirements, including the:

• Student Code of Conduct Policy
• Student Integrity and Misconduct Policy and Procedure
• Assessment Procedure
• Examinations Procedure
• Reasonable Adjustments - Students Policy and Procedure

Learn more about UQ policies on my.UQ and the Policy and Procedure Library.