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Quality Management Refresher Training Course

This seminar has been designed to provide a highly interactive session to refresh key personnel in the principles and practices of Quality Management and bring them up-to-date with the latest legal requirements. The seminar will review the key elements of the Pharmaceutical Quality System (PQS) and the roles and responsibilities of all staff involved in the PQS, including management.
It will also provide a comprehensive overview of the essential principles and requirements of "The Orange Guide” and other relevant regulatory requirements.

23 Sep 2022

& 26 Jan 2023 , 8-9 May 2023 , 28 Sep 2023

Book or reserve now

Details

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. Effective design, implementation, maintenance and monitoring of the PQS are important in meeting customer needs.

This seminar has been designed to provide a highly interactive session to refresh key personnel in the principles and practices of Quality Management and bring them up-to-date with the latest legal requirements.  The seminar will review the key elements of the Pharmaceutical Quality System (PQS) and the roles and responsibilities of all staff involved in the PQS, including management.

It will also provid e a comprehensive overview of the essential principles and requirements of "The Orange Guide” and other relevant regulatory requirements.  

This is an excellent opportunity to hear from an experienced QP and discuss the challenges of Quality Management and its successful application. 

Benefits in attending

  • Keep abreast of the latest regulatory requirements
  • Know your legal and operational responsibilities 
  • Understand the key principles of 'The Orange Guide' and their application 
  • Review how to respond to inspection observations

Who should attend

This course will be suitable for all experienced personnel who need to keep up-to-date with the latest requirements, including those working in the following departments: 

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

Attendance by Qualified Persons is recommended. 

Programme

Introduction and course objectives

Our customers

  • How to meet their needs

Regulatory requirements

  • Overview of legal requirements and recent developments
  • Key licensing requirements
  • PQS and the GMP
  • How to comply

The Pharmacuetical Quality System (PQS)

  • What is a PQS?
  • Key elements
  • Role of the PQS
  • PQS and Supply Chain Management

Roles and responsibilities

  • Leadership at all levels in the PQS
  • Legal and operational responsibilities
  • Culture and the PQS

Principles and requirements of 'The Orange Guide'

  • Overview and use of 'The Orange Guide'
  • Relationship to legal requirements
  • Key chapters
  • Key principles and their application

Regulatory inspections

  • Preparing for inspection
  • Regulatory trends
  • Responding to inspection observations

Q & A

  • Review of key points
  • Questions and discussion

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
23 Sep 2022
Face-to-face, Rembrandt Hotel London
09:00-17:00
UK (London)
23 Sep 2022
Face-to-face
Rembrandt Hotel London
09:00-17:00
UK (London)
GBP 699 599
EUR 979 839
USD 1,090 934
Until 19 Aug*
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
26 Jan 2023
Live webinar
09:15-17:00
UK (London)
26 Jan 2023
Live webinar
09:15-17:00
UK (London)
GBP 649 549
EUR 929 789
USD 1,049 893
Until 22 Dec*
Enrol now
to attend Live webinar
8-9 May 2023
Live webinar
13:30-17:30
UK (London)
8-9 May 2023
Live webinar
13:30-17:30
UK (London)
GBP 649 549
EUR 929 789
USD 1,049 893
Until 3 Apr 23*
Enrol now
to attend Live webinar
28 Sep 2023
Face-to-face, Rembrandt Hotel London
09:00-17:00
UK (London)
28 Sep 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 24 Aug 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

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