Quality Risk Management

This interactive and engaging online workshop will help you master the essential elements of a proactive Risk Management System. By the end of this hands-on workshop, you will have the right tools and knowledge to establish a compliant Risk Management System across the systems and processes of your organization. Those new skills will take the operation at your workplace and your career to a new level.

Sessions:
10 – 13 May 2021 (4 hours per day)
or
08 – 11 November 2021 (4 hours per day)

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Quality Risk Management is one of the most critical pillars of GMP driven industries. It is also one of the main focuses of regulatory bodies these days. Yet, many companies poorly understand the concept of correct risk management and act reactively instead of proactively. For this reason, regulatory bodies issue compliance warnings and warning letters to such companies regularly.

Therefore, to avoid such situations and comply with regulations, you need to understand the concept of proactive risk management correctly and your processes. This workshop covers the essential elements for performing proactive quality risk management tasks within:

  • manufacturing
  • testing
  • control
  • distribution

Additionally, You will learn the best practice frameworks for embedding Quality Risk Management into the business and Pharmaceutical Quality System, with practice sessions for risk identification, risk scoring, and failure mode identification.

By the end of this hands-on workshop, you will have the right tools and knowledge to establish a compliant Risk Management System across your organization. Those new skills will take the operation at your workplace and your career to a new level.

Topics

  • Overview of Quality Risk Management (QRM) Systems
  • Critical Documentation for QRM
  • Proactive Vs. Reactive QRM
  • Planning a QRM (including responsibilities)
  • Defining the scope of a QRM
  • Process flow mapping
  • Risk scoring systems
  • Defining action criteria
  • FMEA – what is a failure mode?
  • Impact of the possible root cause
  • Risk Ranking & Risk Register
  • Embedding the QRM process in your systems

Target Group

This course is of particular importance to quality professionals in all GxP fields (pharma, medical devices, cosmetics, dietary supplements, and food).

Regulators expect companies to embed Quality Risk Management in all aspects of a pharmaceutical business, as evidenced by the words ‘risk-based approach’. This workshop will help you interpret the meaning and implement a proactive risk-based approach in your department or across your organization.

Event Details

The workshop lasts about 16 hours and spreads across four days.
That way, you don't get overwhelmed with too much information at once. Also, you can get back to your urgent projects after your launch break.

Start time: 09:00 CET

End time: 13:00 CET

1.445

Plus 19% VAT

Limited Spots Available

Your Instructor

Alex Hall

QP Trainer & Consultant

Alex is an expert in Pharmaceutical Quality Assurance with 30 plus years in the pharma industry, 20 of those as a Qualified Person. As an instructor, Alex builds on her experience and her previous role as a UK QP Assessor to support QA professionals and QP trainees. She helps trainees achieve the best results through supportive coaching, mentoring, and a straightforward training approach.

You can learn more about Alex from her appearance on The Qualitalks Podcast:

1. When You Deal With Risk, Don’t Be a Firefighter!

2. The Role of the Qualified Person (QP)

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What People Say About Our GMP Online Training

Our online interactive workshops will be presented to you live through a specialized classroom platform. You will be able to attend from home or work, yet feel like we share the same room.

Live Online
GMP Training

Communication

See and communicate with the tutor through a webcam and chat

Interactions

Raise your virtual hand to ask questions

Activities

Partake in polls and quizzes

Teamwork

Participate in exercises with other delegates

Let us Know Your Needs

Please share with us several suitable dates for private training sessions and the number of attendees. We will get back to you with a customized offer as soon as possible. 

Wait, don't leave empty-handed!​

Download our free FMEA guide, which is dedicated to GMP and pharma professionals.

This extensive yet simplified guide to Failure Mode and Effects Analysis (FMEA) will help you master one of the most vital instruments in your risk management toolbox.

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