DEMISTIFYING CLINICAL QUALITY RISK MANAGEMENT…

Learn More About Risk Management Applied to Clinical Trials

“Clinical Quality Risk Management”

THAT´S WHAT INSPIRED US TO DEVELOP THIS NEW AND EFFECTIVE CQRM COURSE

All the guidance documents published by the Regulatory Authorities during the COVID-19 Pandemic, highlight the need for risk assessments to be conducted by the clinical trials sponsors and Clinical Research Organizations (CRO). However, conducting risk assessments and developing adequate Risk Management Plans (RMP) are not easy tasks, and not all the organizations conducting clinical trials have robust Quality Risk Management (QRM) programs.

Thankfully, all of that is behind you…

INTRODUCING THE CQRM COURSE

In clinical trials we manage risks every day, this training covers a systematic approach on how to better do it according to ICH GCP E6 (R2).

The complexity of current global clinical trials requires of a more systematic approach to ensure the quality that patients, regulators and society expect for the treatments we deliver.

This training is oriented to professionals like you who manage risks in organizations, make decisions, set and achieve objectives and improve performance.

 

Chapter

Topic

1

Training Goals and Course Content

2

Introduction

3

Principles of Quality Risk Management

4

Quality Risk Management Program

5

Quality Risk Management Process

5.1

Clinical Quality Risk Management Overview

5.2

Critical Process and Data Identification

5.3

Risk Assessment

5.4

Risk Control

5.5

Risk Communication

5.6

Risk Reporting

5.7

Risk Control

6

Quality Risk Management Tools and Methodologies

7

Conclusion

THIS CQRM COURSE WILL HELP YOU TO:

Save time when conducting risk assessment and provide clarity on the areas you need to focus on to guarantee a successful and stress free clinical trial.

Implement a clear process and receive a step by step guidance on how to conduct Quality Risk Management.

Understand Quality Risk Management principles (which are the key criteria for its success), goals, and how to achieve those goals in the Clinical Research setting.

Know how to identify, evaluate, prioritize and control risks and how to implement specific techniques for risk management according to ICH GCP E6 (R2).

Learn how the Quality Risk Management process can help companies to be more proactive and improve the quality in their clinical trials

WHAT MAKES THIS CQRM COURSE DIFFERENT?

Expertise

Years of GCP Auditing and Clinical Quality Assurance experience have been incorporated into this course aiming to provide practical advice to professionals managing clinical trials based on expert interpretation of GCP and other applicable regulations, and industry best practices.

Committed To Improve The Quality Of Clinical Trials

This course will help you to understand how QRM can improve the quality of your trial by guiding you through a powerful risk management process. We present risk management as a core element of an effective Quality Management System (QMS).

Focused On Key Areas

This training course reinforces the need to focus on errors that matters and not to treat every error equally to avoid unnecessary burden and overload resources. It clearly explains that potential issues should be identified before activities are undertaken and how to addresses them proactively.

You will discover how to identify those risks that matter associated with your clinical project, classify those risks, evaluate, and prioritize them.

Practical Advice

Our focus is not only on summarizing the QRM key steps, but we also include explanations and examples of the key deliverables such as for example Risk Management Log, Risk Management Plan.

The components of a QRM program are broken down including foundational elements and QRM methods appropriate for clinical development.

This training course provides you with the basics for risk management processes that can be immediately applied to your clinical trials.

LIMITED TIME FREE BONUSES!

fmea-image-sales-page-scaled

Course Bonus #1 | €100 Value
Most frequently used QRM tools

This is a limited time bonus for signing up today which will help you to implement the clinical QRM processes, covering:
  • Risk Management Log template (Excel)
  • FMEA template (Excel)
  • HACCP template (Excel)

MEET THE TRAINER

The course was designed and written by Dr Leire Zúñiga with the input from recognized clinical research professionals worldwide.

Dr Leire Zúñiga is the Founding Director and Principal GCP Consultant of Pharmity.
Leire has worked in the Pharmaceutical, Biotech and CRO industries since 2003 within Quality Assurance.
Just before moving to the consulting area and setting up Pharmity, Leire worked as a Senior Quality Assurance Manager in one of the largest CROs working as part of a global compliance team for internal and external clients worldwide.
During her professional career Leire has developed an in-depth knowledge in Quality Assurance, having conducted GxP and CSV audits across the globe.

The training course was recorded by one of the Pharmity’s native English speaker collaborators.

LOOK WHAT THEY SAY ABOUT THIS COURSE

Jörg

Quality Assurance Manager (Germany)


Easy to follow and assimilate while covering various and important aspects of risk management for clinical trials. The chapters were very well delivered with proper explanation of all the topics and lessons. Thumbs up!

Claudia

Global Project Manager (UK)


I found the chapter on quality risk management process especially interesting; it pulled the course together. Overall, the content was excellent.

Lisa

Clinical Operations Manager (US)


I’ve been trying to learn clinical quality risk management to increase my skills and this course was perfect! The video tutorials helped a lot. Great course!

FREQUENTLY ASKED QUESTIONS

So, you have questions? Let us try to answer those for you...

Who should join the course?
This course is for professionals who create and protect value in organizations by managing risks, and anyone who wants to elevate their CQRM knowledge, including but not limited to the following departments:
  • Project Management
  • Clinical Operations
  • Clinical Data Management
  • Statistical Departments
  • Quality Assurance
  • Regulatory Affairs
  • Pharmacovigilance
  • Information Technology
It doesn’t matter if you are completely new to CQRM, no prior CQRM knowledge is necessary to participate in this course.
How long do I have to access to the course?
You can work through the course chapters at your own pace. The course will remain available online for you for 6 months after your registration.
How is the course structured?
The course is made up of seven learning chapters consisting of narrated video tutorials.
Some of the chapters contain downloadable attachments that aim to complement the learning process.
How long does it take to complete the seven chapters?
This depends on how much time you have to spend each day on watching the videos. The total duration of the course videos is 2 hours.
Am I required to complete the seven chapters?
Yes, all seven chapters make up the training. The learners need to follow the pre-established chapters order, not being allowed to progress to the following section of the course until they have completed the previous one.
Will I obtain a Course Certificate?
Once you complete all the course chapters you will be requested to take an online exam which consists of multiple-choice questions. A certificate is issued once a minimum of 80% is achieved in the final quiz. The quiz can be taken multiple times until you pass with a satisfactory score.
Corporate licenses?
Multi-user licenses for corporate use are also available, please contact us for prices and further information. The larger the group, the better the price.

If there's anything at all that you're not certain about, anything we haven't made clear; any concerns or questions then please do contact us at and we'll help you out.

JOIN NOW TO SECURE THIS SPECIAL "COURSE LAUNCH" DISCOUNTED PRICE

 
favicon

Get Instant Access to the Course!

197One-time payment!

This is what you'll get:

  • 7 Chapters & 7 Subchapters
  • 10+ Video Tutorials
  • Certificate of Course Completion
  • ...and more!
©2020 Pharmity. All rights reserved.