Risk management is becoming increasingly important to drug and medical device development and ensuring compliance with regulatory expectations and during challenging times such as a pandemic. There are now numerous pharmaceutical guidelines covering risk management including ICH Q9, ICH GCP R2, drug and device risk-based guidance during a pandemic, regulatory risk-based approaches, and the recently finalised FDA Risk-based monitoring of Clinical Investigation questions and answers guidance.
This essential course will explain the importance of using risk management techniques in drug and device development to comply with the latest focus on inspection in this area. It will show you how risk management can improve the quality of your development projects and demonstrate the importance of using risk analysis and risk management techniques in the pharma, biopharma and medical device industries. You will learn how to identify, evaluate and implement specific risk-based techniques for risk management, including a quality management framework.
The course will enable you to develop quality risk management principles applicable to pharma, biopharma and device development, as well as to identify and share best practices for risk management tools and approaches.
Benefits of attending
- Understand risk management tools and when and how the tools are used in pharmaceutical, biopharmaceutical and medical device projects
- Learn how to plan risk-based approaches, how to document and where to focus to meet regulatory requirements and expectations
- Develop and apply risk management principles and tools to your development projects
- Identify and share best practices for implementing risk-based tools and principles
Agenda
A brief overview of risk management
- Why risk management is important
- Definitions of key risk management terminology
- Brief overview of regulations and guidelines which cover risk management applied to the pharma and biopharma industry
Risk-based quality management system (QMS) - what does this really mean? How does it look?
- What are the elements of a QMS which include risk
- What does a regulatory inspector expect to be in place for clinical trials?
- Group discussion on using a clinical QMS, including risk
Risk-based processes/tools and techniques
- Examples of risk management processes
- Risk based tools including:
- Root cause analysis
- Risk breakdown structure
- Risk log
- Failure mode and effect analysis
- Risk Matrix
- Examples of pharmaceutical risk tools for clinical trials included Risk Assessment Categorization Tool
Brief review of risk-based approaches to auditing
- Example of best practice guide - RQA (Research Quality Association)
Speakers
Dr Laura Brown,
Pharmaceutical QA and Training Consultant ,
University of CardiffDr Laura Brown MBA, BSc,PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’ experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including “The Planning of International Drug Development”, in the Clinical Research Manual, Euromed and the “Impact of Brexit”, RQA Journal 2017.
Who Should Attend
Anyone who is needs to understand risk management working in the pharmaceutical and medical device industry. Particularly those needing to understand the regulatory expectations, associated guidance and be able to apply different tools and techniques in their role.
