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Management Forum

An Introduction to Quality Management for Managers Training Course

This seminar has been designed to provide a highly interactive introduction to Quality Management for managers and will provide the opportunity to share and consolidate the key elements of the Pharmaceutical Quality System (PQS). It will provide practical advice and guidance on how to ensure legal and operational responsibilities are fulfilled.

15 Jun 2022 + 2 more dates

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  • Format: Live online, Classroom
  • CPD: 6 hours for your records
  • Certificate of completion

Course Overview

The manufacture of pharmaceutical products requires the establishment and implementation of an effective ‘Pharmaceutical Quality System’ (PQS). The concepts of QA, GMP and Quality Control (QC), which are inter-related, form the basis of such a system for the manufacture of pharmaceutical products from initial development, through clinical phases to commercial and supply.

This seminar has been designed to provide a highly interactive introduction to Quality Management for managers and will provide the opportunity to share and consolidate the key elements of the Pharmaceutical Quality System (PQS). It will describe the roles and responsibilities of middle and senior management in the PQS and provide practical advice and guidance on how to ensure legal and operational responsibilities are fulfilled.

The seminar will also consider the importance of effective leadership and how leaders demonstrate the behavioural standards required for an effective “quality culture” that supports the PQS.

The seminar will also provide a comprehensive overview of the essential principles and requirements of the “Orange Guide” and other relevant regulatory requirements.  

Who Should Attend

This course will be suitable for Middle Management from the following: 

  • Production,
  • Engineering
  • QA
  • Technical Support
  • Regulatory Affairs
  • Supply Chain
  • Procurement
  • Warehousing

It will also be appropriate for Senior Management, including the head of any department who is a member of a site senior team, including departments listed above as well as HR and Finance.

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The An Introduction to Quality Management for Managers course will cover:

Introduction and Course Objectives

What is a PQS?

  • Key elements
  • Role of the PQS
  • PQS and Supply Chain Management

Regulatory Requirements

  • Key Licensing Requirements
  • PQS and the GMP
  • How to comply

Roles and Responsibilities of Managers

  • Leadership in the PQS
  • Legal and operational responsibilities
  • The importance of culture and interpersonal skills

Principles and Requirements of The Orange Guide

  • Overview and Use of the Orange Guide
  • Key principles and their application

Regulatory Inspections

  • Preparing for inspection
  • Responding to inspection observations

How to Successfully Monitor and Oversee the PQS

  • Management Review
  • Maintaining a robust PQS infrastructure

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Rob Hughes

Rob Hughes has worked in the pharmaceutical industry for more than 35 years.

Rob started his career in control laboratories before gaining accreditation as a “Qualified Person”.

During his career, he has held operational, project and senior strategic
leadership positions in commercial manufacturing and development QA. Rob has experience of the application of quality assurance in control laboratories, active substance, solids, creams and liquids manufacture, supplier evaluation and in regulatory inspections.

In the strategic roles, Rob was responsible for the leadership of global groups, which developed and rolled out quality systems across the company network of sites.

Rob spent two years in R&D project management with a focus on the reduction of development timelines, prior to establishing his consultancy in 2012.

Since then, Rob has worked with many different companies in the development, remediation and implementation of quality systems, training of staff from operator to management level and auditing of quality systems.


More details

Book An Introduction to Quality Management for Managers Live online/Classroom training

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

15 Jun 2022

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 12067

  • GBP 599
  • EUR 859
  • USD 970

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15 Sep 2022

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 12071

  • GBP 499 599
  • EUR 719 859
  • USD 814 970

Until 11 Aug

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13 Dec 2022

Classroom
Rembrandt Hotel
London

09:00-17:00 UK (London)
Course code 12072

  • GBP 599 699
  • EUR 839 979
  • USD 934 1,090

Until 08 Nov

  • 1 day classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

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* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy