Available courses

Module 2: Fundamentals of Risk Management V2.0

Module 2: Fundamentals of Risk Management V2.0

Module Learning Objectives

Knowing

Gain clarity on the core Risk Management concepts. 

Know the distinction between the management of risk and the assessment of risk.

Understand the impact of human bias on decision-making.

Doing

Be able to complete a risk ranking and a risk scoring exercise and perform rudimentary data analysis for estimating probabilities.

Identify appropriate strategies  to reduce the influence of bias on Risk Management outcomes.

Being

Be OK with saying, “I don’t know the answer to that question”.

Be curious.

Be transparent and brave when contributing to a Risk Management activity.

Together, these should ensure you are confident to participate in a range of risk management activities and continue to emphasise the potential impact of your behaviours on the reduction of risk for your patients and your organization.

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Module 1: Patient Focused Risk Management V2.0

Module 1: Patient Focused Risk Management V2.0

Learning Objectives, Fundamentals of Effective Risk Management for Biopharmaceutical Manufacture

Knowing

Understand what is meant by biopharmaceutical product risk. 

Be able to explain the importance of examining risk through the lens of the patient.

Doing

Be able to identify and classify different types of product risk.

Be able to identify the key stakeholders and explain why the patient comes first.

Being

Embrace the importance of a proactive risk culture.

Make a personal commitment to always prioritize patient safety.

Together, these should enable you to confidently participate in a range of risk-based decision making activities. 

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Module 3 Regulatory Requirements for QRM in the Biopharmaceutical Industry V2.0

Module 3 Regulatory Requirements for QRM in the Biopharmaceutical Industry V2.0

The main focus of this module is to familiarize you with the key regulatory requirements, industry guidance and international standards associated with Risk Management and to make the connection to the underpinning current cGMPs.  Armed with this knowledge you should feel confident to contribute to QRM activities.

Module Learning Objectives

Knowing

Know the current Risk Management regulations for biopharmaceutical manufacture.​

Be aware of what the regulators are looking for in your Risk Management programs and practices.​

Understand the connection between the GMPs and Risk Management.

Doing

Identify the core frameworks from the relevant regulations (e.g. ICH Q9, ISO 14971, WHO TRS 981) 

Distinguish between formal and informal risk management tools.

Being

Practice the behaviors necessary to meet and exceed the minimum compliance requirements.

Confidently contribute to risk management activities .​

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Course Assessment: Fundamentals of Effective Risk Management for Biopharmaceutical Manufacture V2.0

Course Assessment: Fundamentals of Effective Risk Management for Biopharmaceutical Manufacture V2.0

In this scenario, as part of the corporate Learning and Development Emerging Leader program for new employees, you will take the role of Jane, a new QA Executive, who is spending a week on job rotation with John, the Risk Management Lead for the site.  Jane will shadow John this week to gain a greater understanding of the overall Corporate QRM Program and to experience first-hand how risks are managed on a day-to-day basis on the site. 

Included in this scenario-based course assessment are 33 multiple choice questions. You will need a score of 80% to pass. You may re-take the assessment as many times as you wish. 

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Module 6: Your Role in Preventing and Reducing Product and Patient Risk V2.0

Module 6: Your Role in Preventing and Reducing Product and Patient Risk V2.0

Module Learning Objectives

Knowing

Understand that Risk Management is everyone's job.

Doing

Practice risk awareness and risk curiosity everyday. 

Being

Demonstrate by your actions that you appreciate the fact that your individual actions may either uncover or contribute to a risk event.


Teacher: Joe Brady

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Module 5: Application of Quality Risk Management Every Day V2.0

Module 5: Application of Quality Risk Management Every Day V2.0

Module Learning Objectives

Knowing

Have an opportunity to review worked examples of everyday QRM examples. 

Participate in a Validation Risk Management Scenario.

Doing

Be able to select appropriate actions or tools for a range of given risk events. 

Being

Describe the importance of involving individuals with a diverse range of skills and perspectives.

Demonstrate the importance of maintaining vigilance and personal accountability.   

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Module 4: Implementing Effective Risk Control Strategies V2.0

Module 4: Implementing Effective Risk Control Strategies V2.0

Module Learning Objectives

Knowing

Be clear on what the “State of Control” means. 

Describe what a Product Control Strategy is. 

Gain further clarity about integration across the Risk Control Lifecycle. 

Doing

Actively engage in structured risk planning.

Critically evaluate the effectiveness of current risk controls.

Be able to access publicly available sources of risk control failures. 

Being

Be confident. 

Be curious.

Communicate, communicate, communicate. 


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Course Assessment: Fundamentals of Effective Risk Management for Biopharmaceutical Manufacture

Course Assessment: Fundamentals of Effective Risk Management for Biopharmaceutical Manufacture

Course Assessment: Fundamentals of Effective Risk Management for Biopharmaceutical Manufacture

This unique scenario-based assessment provides competency-based assessment and certification to test your comprehension of how to apply effective behaviour-based Quality Risk Management within the biopharmaceutical industry.


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Module 6: Your Role in Preventing and Reducing Product and Patient Risk

Module 6: Your Role in Preventing and Reducing Product and Patient Risk

Module 6: Your Role in Preventing and Reducing Product and Patient Risk

This module is designed to enable you to reflect on your learning across the course and to reinforce the importance of the role that you play everyday in preventing and reducing product and patient risk.

After completing this module, you will have achieved the following “Knowing, Doing, Being” learning objectives:

Knowing

  • Understand that Risk Management is everyone's job.

Doing

  • Practice risk awareness and risk curiosity everyday.

Being

  • Demonstrate by your actions that you appreciate the fact that your individual actions may either uncover or contribute to a risk event.

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Module 5: Application of Quality Risk Management Every Day

Module 5: Application of Quality Risk Management Every Day

Module 5: Application of Quality Risk Management Every Day

In this module you will review some examples of the everyday application of Risk Management.

After completing this module, you will have achieved the following “Knowing, Doing, Being” learning objectives:

Knowing

  • Have an opportunity to review worked examples of everyday QRM examples.
  • Participate in a Validation Risk Management Scenario.

Doing

  • Be able to select appropriate actions or tools for a range of given risk events.

Being

  • Describe the importance of involving individuals with a diverse range of skills and perspectives. 
  • Demonstrate the importance of maintaining vigilance and personal accountability.

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Module 4 Implementing Effective Risk Control Strategies

Module 4 Implementing Effective Risk Control Strategies

Module 4: Implementing Effective Risk Control Strategies

In this module you will have the opportunity to familiarize yourself with the typical risk controls in place for products and processes in a biopharmaceutical manufacturing setting.

After completing this module, you will have achieved the following “Knowing, Doing, Being” learning objectives:

Knowing

  • Be clear on what the “State of Control” means.
  • Describe what a Product Control Strategy is.
  • Gain further clarity about integration across the Risk Control Lifecycle.

Doing

  • Actively engage in structured risk planning.
  • Critically evaluate the effectiveness of current risk controls.
  • Be able to access publicly available sources of risk control failures.

Being

  • Be Confident.
  • Be Curious.
  • Communicate, communicate, communicate.

Click to enter this course

Module 3 Regulatory Requirements for QRM in the Biopharmaceutical Industry

Module 3 Regulatory Requirements for QRM in the Biopharmaceutical Industry

Module 3 Regulatory Requirements

The main focus of this module is to familiarize you with the key regulatory requirements, industry guidance and international standards associated with Risk Management and to make the connection to the underpinning current cGMPs. Armed with this knowledge you should feel confident to contribute to QRM activities.

After completing this module, you will have achieved the following “Knowing, Doing, Being” learning objectives:

Knowing

  • Know the current Risk Management regulations for biopharmaceutical manufacture.
  • Be aware of what the regulators are looking for in your Risk Management programs and practices.
  • Understand the connection between the GMPs and Risk Management.

Doing

  • Identify the core frameworks from the relevant regulations (e.g. ICH Q9, ISO 14971, WHO TRS 981).
  • Distinguish between formal and informal risk management tools.

Being

  • Practice the behaviors necessary to meet and exceed the minimum compliance requirements.
  • Confidently contribute to risk management activities.

Click to enter this course

Module 2 Fundamentals of Risk Management, Fundamentals of Effective Risk Management for Biopharmaceutical Manufacture

Module 2 Fundamentals of Risk Management, Fundamentals of Effective Risk Management for Biopharmaceutical Manufacture

Module 2

In this module you will build your awareness of the science and tools of risk management and understand the potential impact of your behaviours on the reduction of risk for your patients and your organization.

After completing this module, you will have achieved the following “Knowing, Doing, Being” learning objectives:

Knowing

  • Gain clarity on the core Risk Management concepts.
  • Know the distinction between the management of risk and the assessment of risk.
  • Understand the impact of human bias on decision-making.

Doing

  • Be able to complete a risk ranking and a risk scoring exercise and perform rudimentary data analysis for estimating probabilities. 
  • Identify appropriate strategies to reduce the influence of bias on Risk Management outcomes.

Being

  • Be OK with saying, “I don’t know the answer to that question”.
  • Be curious.
  • Be transparent and brave when contributing to a Risk Management activity.

Click to enter this course

Module 1: Patient Focused Risk Management, Fundamentals of Effective Risk Management for Biopharmaceutical Manufacture

Module 1: Patient Focused Risk Management, Fundamentals of Effective Risk Management for Biopharmaceutical Manufacture

Module 1: Patient Focused Risk Management
After completing this module, you will have achieved the following “Knowing, Doing, Being” learning objectives:

Knowing

  • Understand what is meant by biopharmaceutical product risk.
  • Be able to explain the importance of examining risk through the lens of the patient.

Doing

  • Be able to identify and classify different types of product risk.
  • Be able to identify the key stakeholders and explain why the patient comes first.

Being

  • Embrace the importance of a proactive risk culture.
  • Make a personal commitment to always prioritize patient safety.

Click to enter this course

Test Course

Test Course

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