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Risk Management for Pharma and Biopharma Professionals Training Course

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.

29 Apr 2022

& 14 Oct 2022

Book now

Details

Course overview

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 ISO standards.

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

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.

Programme

An overview of risk management

  • Why risk management is important
  • Definitions of key risk management terminology
  • Brief overview of regulations and guidelines which cover up 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)

Presenter

Laura Brown (More...)

Dr Laura Brown is an independent pharmaceutical QA, management and training consultant and Senior Lecturer for the MSc in Clinical Research, School of Pharmacy, University of Cardiff. Laura has more than 20 years’ experience of quality assurance and managing international clinical trials including risk identification and management. She has worked for several leading companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International and is an international expert on GCP and clinical trial requirements. Laura was chair of the Institute of Clinical Research GCP Forum for six years and writes regularly on clinical research regulatory requirements.

Book now

Book now

29 Apr 2022
Live webinar
29 Apr 2022
Live webinar
GBP 599 499
EUR 859 719
USD 970 814
Until 25 Mar 22*
Enrol now
to attend
Live webinar
14 Oct 2022
Live webinar
14 Oct 2022
Live webinar
GBP 599 499
EUR 859 719
USD 970 814
Until 9 Sep 22*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

Continuing professional development

This course qualifies for 6 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

Previous customers include...

  • Ipsen Innovations
  • St George's University Hospital