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Management Forum

Quality Management Refresher Training Course

Keeping up-to-date with your legal and operational responsiblities

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.

29 Sep 2022 + 1 more date

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

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. 

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The Quality Management Refresher course will cover:

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

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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 Quality Management Refresher Classroom/Live online 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*

29 Sep 2022

Classroom
Rembrandt Hotel
London

09:00-17:00 UK (London)
Course code 12103

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

Until 25 Aug

  • 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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26 Jan 2023

Live online

09:15-17:00 UK (London) (UTC+00)
10:15-18:00 Paris (UTC+01)
04:15-12:00 New York (UTC-05)
Course code 12104

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

Until 22 Dec

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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