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Management Forum

GMP (Good Manufacturing Practice) Fundamentals Training Course

An essential overview of the legal requirements for pharmaceutical manufacture, the PQS and the delviery of GMP

This two-day seminar will consider the relationship between the legal requirements for pharmaceutical manufacture, the PQS and the delivery of GMP. It will provide a highly interactive session to discuss the key elements of the PQS and the relationship with GMP as described in the “Orange Guide”, including the practical application of GMP in manufacturing and quality control.

30 Jun-1 Jul 2022 + 2 more dates

Need help?  Enrol now

  • Format: Live online

Overview

Pharmaceutical manufacturers are required to meet and maintain Good Manufacturing Practice (GMP) as a condition of the licence granted by the regulatory authorities.

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

This two-day seminar will consider the relationship between the legal requirements for pharmaceutical manufacture, the PQS and the delivery of GMP. It will provide a highly interactive session to discuss the key elements of the PQS and the relationship with GMP as described in the “Orange Guide”, including the practical application of GMP in manufacturing and quality control.

Benefits in Attending

  • Understand the legal requirements and how to comply
  • Learn the key elements and role of the PQS
  • Know your operational responsibilities
  • Gain insight in to the principles of the ‘The Orange Guide’  
  • Understand the key requirements of CAPA and Change Control
  • Consider the key elements of supply chain management
  • Get an introduction on how to prepare for regulatory inspections

Who Should Attend

This course will be suitable for all personnel in the pharmaceutical industry who have limited or no experience with the current GMP reqiurements working in the following departments: 

  • Production
  • Engineering
  • Quality Assurance (QA)
  • Technical Support
  • Regulatory Affairs
  • Supply Chain
  • Procurement
  • Warehousing

It will also be beneficial to Qualifed Persons, and experienced personnel who are working for the first time in a GMP regulated environment. In addition, it will be useful to suppliers who have to understand the quality requirements of their customers.

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The GMP Fundamentals course will cover:

Introduction and course objectives

Our customers

  • How to meet their needs

Regulatory requirements

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

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

Deviation and CAPA management

  • Key principles
  • Practical application

Change control/management

  • Key principles for an effective system

Complaints and recalls

  • Key requirements
  • CAPAs

Supply chain

  • Management of suppliers of materials, product and services
  • PQS considerations

Regulatory inspections

  • Preparing for inspection
  • Regulatory trends

Management review

  • Maintaining and improving the PQS
  • Regulatory trends

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 GMP Fundamentals 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*

30 Jun-1 Jul 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 12099

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 26 May

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18-19 Oct 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 12100

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 13 Sep

View basket 

18-19 Jan 2023

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 12667

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 14 Dec

Online registration unavailable: this date is nearing full capacity; please contact us to register.

* 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