Master Class: Quality Management

In this live online master class, you will learn everything you need to master GMP Quality Management, maintaining an effective quality system.

The 80-hours master class consists of seven workshops:

  1. Deviations and Issue Management Systems (8 hours)
  2. Root Cause Analysis Process (16 hours)
  3. Corrective Actions and Continual Improvement Management System (8 hours)
  4. Good Documentation Practice (8 hours)
  5. Writing Standard Operating Procedures (8 hours)
  6. Quality Risk Management (16 hours)
  7. Change management systems (16 hours)

Dates and time below.

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Quality Managers (QM) and Qualified Persons (QP) need to make tough decisions every day. In fact, those decisions have an impact on the business and the quality of the product. Therefore, QMs and QPs must be a generalist and have an excellent understanding of the overall GMP quality system.

To be a good Quality Manager or Qualified Person in a GMP environment, you need to know how to:

  1. manage documentation correctly,
  2. write clear Standard Operation Procedures (SOPs),
  3. deal with deviations quickly and efficiently,
  4. investigate the root cause of issues effectively,
  5. evaluate, analyze and deal with risk in an appropriate manner,
  6. create useful CAPAs and establish a continuous improvement system across the organization,
  7. and manage all of the above with an adequate change control system.

It sounds complicated, but don’t worry- with our simplified and engaging Master Class, you will master all of the above within next year.

The 80-hours Master Class consists of seven workshops, which are spread across the year. Additionally, you will have the option the choose one of the available two dates to suit your schedule.

 

Topics: Deviations

  • Deviation/investigation Process overview
  • Correct documentation of deviations
  • Impact/Risk assessment
  • Efficient Event Investigation
  • Correction and follow-up
  • Implementation of Deviation/investigation process

Topics: CAPAs

  • CAPA process overview
  • Sources of CAPA and documentation
  • SMART actions
  • Status reporting/rescheduling
  • Effectiveness checks
  • Implementation of a CAPA process

Topics: Root Cause Analysis

  • Root Cause Analysis Overview
  • Correct Documentation of RCA
  • Impact / Risk assessment
  • Team set up and planning
  • Defining the problem
  • Process flow map
  • IS / IS NOT
  • Cause and Effect
  • 5-Whys
  • Fault tree analysis
  • Root Cause and Causal Factors
  • Embedding the process

The workshop will allow you to align yourself with all the requirements of ICH Q10 and ISO 9001:2015 regarding events investigation.

Topics: Good Documentation Practice

  • Document lifecycle/types of documents overview
  • Data integrity
  • Document control
  • Good Documentation Practice
  • Document retention and destruction
  • Implementation of document control system

Topics: Change Management Systems

  • Overview of Change Management
  • How to write change proposals
  • Procurement process
  • Regulatory Affairs process
  • Impact & risk assessment
  • Role of Change management board
  • Project management
  • Implementing change
  • When to close a change control
  • Effectiveness checks
  • Failure of change
  • Embedding the process

Topics: Quality Risk Management

  • 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

Topics: SOPs

  • SOP vs. instructions
  • Overview of different types of SOP/instructions
  • Standard content
  • Writing styles
  • Documentation control
  • Implementation of the SOP system

Dates & Time

You can choose suitable session dates for you during checkout. 

Every lesson begins at 09:00 (CET)

 

Deviations and Issue Management Systems Workshop

Sessions:
27 – 28 July 2021 (4 hours per day)

Corrective Actions and Continual Improvement Management System Workshop

Sessions:
21 – 22 September 2021 (4 hours per day)

Root Cause Analysis Process Workshop

Sessions:
01 – 04 June 2021 (4 hours per day)

Good Documentation Practice Workshop

Sessions:
09 – 10 March 2021 (4 hours per day)
07 – 08 September 2021(4 hours per day)

Change Management Systems Workshop

Sessions:
05 – 08 July 2021 (4 hours per day)
22 – 25 November 2021 (4 hours per day)

Quality Risk Managemen Workshop

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

Writing Standard Operating Procedures Workshop

Sessions:
13 -14 April 2021 (4 hours per day)
12 – 13 October 2021 (4 hours per day)

 

*Plus 30 minutes break per day.

5.775

Plus 19% VAT

Limited Spots Available

You will be able to select suitable session dates during checkout.

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)

What People Say About Our GMP Online Training

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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