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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 Sep 2022

& 13 Dec 2022 , 27 Mar 2023 , 14 Jun 2023 , 14-15 Sep 2023 , 1 Dec 2023

Book or reserve now

Details

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.

Programme

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

Presenter

Rob Hughes (More...)

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.


Book now

Book or reserve now

NEW higher discounts for booking multiple places - 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

Choose your date below - or reserve your place with no obligation for 7 days at ipi.academy: Reserve now
15 Sep 2022
Live webinar
09:30-17:00
UK (London)
15 Sep 2022
Live webinar
09:30-17:00
UK (London)
GBP 599.00
EUR 859.00
USD 970.00
+ VAT @ 20.00%
Enrol now
to attend Live webinar
13 Dec 2022
Face-to-face, Rembrandt Hotel London
09:00-17:00
UK (London)
13 Dec 2022
Face-to-face
Rembrandt Hotel London
09:00-17:00
UK (London)
GBP 699 599
EUR 979 839
USD 1,090 934
Until 8 Nov*
Enrol now
to attend Face-to-face
Rembrandt Hotel London
  • 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
27 Mar 2023
Live webinar
09:30-17:00
UK (London)
27 Mar 2023
Live webinar
09:30-17:00
UK (London)
GBP 649 549
EUR 929 789
USD 1,049 893
Until 20 Feb 23*
Enrol now
to attend Live webinar
14 Jun 2023
Face-to-face, Rembrandt Hotel London
09:00-17:00
UK (London)
14 Jun 2023
Face-to-face
Rembrandt Hotel London
09:00-17:00
UK (London)
GBP 749 649
EUR 1,079 939
USD 1,209 1,053
Until 10 May 23*
Enrol now
to attend Face-to-face
Rembrandt Hotel London
  • 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
14-15 Sep 2023
Live webinar
13:30-17:15
UK (London)
14-15 Sep 2023
Live webinar
13:30-17:15
UK (London)
GBP 649 549
EUR 929 789
USD 1,049 893
Until 10 Aug 23*
Enrol now
to attend Live webinar
1 Dec 2023
Live webinar
09:30-17:00
UK (London)
1 Dec 2023
Live webinar
09:30-17:00
UK (London)
GBP 649 549
EUR 929 789
USD 1,049 893
Until 27 Oct 23*
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. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.

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