Scheduled In-house

GxP Training Courses

GxP (Good x Practice) is a series of quality guidelines and regulations created to ensure that bio/pharmaceutical products that are consumed, or used by humans or animals are safe, meet their intended use, and adhere to quality processes during manufacturing, control, storage, and distribution. GxP is an abbreviation of referencing the various ‘good practice’ regulations in the life sciences industry. G (Good) P (Practice) x (variable depending on the application) covers a wide range of processes used in development, manufacturing and distribution of regulated products, such as; Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Distribution Practice (GDP) and Good Laboratory Practice (GLP) etc. We offer a range of essential GxP training across a variety of areas to ensure you comply with the regulations and quality guidelines.

  • Next: 31 Jan-3 Feb 2023 Live online
  • Also: 23-24 May 2023 Live online
  • Also: 27-28 Sep 2023 Live online

An Introduction to Pharmaceutical Packaging

Live online
Focused

This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.

  • 12 CPD hours
  • Presented by Mr Chris Penfold
  • Next: 13 Dec 2022 Classroom
  • Also: 27 Mar 2023 Live online
  • Also: 14 Jun 2023 Classroom
  • + 2 more

An Introduction to Quality Management for Managers

New for 2022

Live online, Classroom
Focused

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.

  • 6 CPD hours
  • Presented by Rob Hughes
  • Next: 20-21 Oct 2022 Classroom
  • Also: 2-3 Mar 2023 Live online
  • Also: 6-7 Jul 2023 Classroom
  • Also: 26-27 Oct 2023 Live online

Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products

New for 2022

Live online, Classroom
Focused

The regulatory requirements for Biological drug products are complex, and pharmaceutical companies are continuously under pressure to ensure regulatory compliance from drug discovery to post-marketing surveillance. This course has been designed to help you navigate the complex regulatory requirements for biological drugs, including ATMPs. It will clearly depict the differences between small and large molecules and the development approaches which reflect the type of molecule. It will address the key aspects of the CTD, look at the CMC regulatory requirements during different stages of development, and discuss the importance of change control.

  • 12 CPD hours
  • Presented by Mr Andrew Willis
  • Next: 10 Oct 2022 Live online
  • Also: 21 Apr 2023 Live online
  • Also: 24 Jul 2023 Classroom
  • Also: 1 Dec 2023 Live online

Data Integrity and Document Management

Live online, Classroom
Focused

Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 7-8 Nov 2022 Live online

Development of Combination Products: Critical Interactions

Live online
Focused

Linking the technical requirements of device design and pharmaceutical product development. Using QbD to deliver drug/device combinations.

  • 12 CPD hours
  • Presented by Mr Andrew Willis
  • Next: 11-12 Oct 2022 Live online
  • Also: 24-25 Jan 2023 Live online
  • Also: 19-20 Apr 2023 Live online
  • + 2 more

Effective Technology Transfer

Live online, Classroom
Focused

The ‘how to’ of technology transfer across the product lifecycle

  • 12 CPD hours
  • Presented by Mr Bruce Davis
  • Next: 18-19 Oct 2022 Live online
  • Also: 18-19 Jan 2023 Live online
  • Also: 19-20 Apr 2023 Live online
  • + 2 more

GMP Fundamentals

New for 2022

Live online, Classroom
Focused

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.

  • Presented by Rob Hughes
  • Next: 1-2 Dec 2022 Classroom
  • Also: 23-24 Mar 2023 Live online
  • Also: 6-7 Jul 2023 Live online
  • Also: 30 Nov-1 Dec 2023 Classroom

Medical Device Single Audit Programme (MDSAP)

New for 2022

Live online, Classroom
Focused

The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of the quality management systems (QMS) used by manufacturers of medical devices. This course will prepare you to host a MDSAP audit within your organisation, and allow you to determine if your own internal QMS processes are consistent with requirements of the MDSAP for the jurisdictions where your products are marketed, or for those markets which you are planning to access.

  • 12 CPD hours
  • Presented by Dr Eamonn Hoxey
  • Next: 6-7 Oct 2022 Live online
  • Also: 6-9 Feb 2023 Live online
  • Also: 20-21 Jun 2023 Classroom
  • Also: 16-17 Oct 2023 Live online

Pharmaceutical Development of ATMPs

Live online, Classroom
Focused

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

  • 12 CPD hours
  • Presented by Mr Andrew Willis
  • Next: 12-13 Dec 2022 Live online

Pharmaceutical Packaging, Labelling and Artwork Origination

Live online
Focused

This course has been designed to present a number of important developments in pharmaceutical packaging and labelling from regulations, standardisation and technology to innovation and artwork origination.

  • 12 CPD hours
  • Presented by Mr Christopher Waterhouse
  • + 6 more
  • Next: 29-30 Nov 2022 Live online
  • Also: 2-3 Mar 2023 Live online
  • Also: 17-18 Jul 2023 Classroom
  • Also: 27-30 Nov 2023 Live online

Practical Implementation of GCP in Veterinary Field Studies

Live online, Classroom
Focused

This seminar will take many aspects of animal health and veterinary research and development through a typical clinical trial, and pay attention to compliance with Good Clinical Practice (GCP) as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP.

  • 12 CPD hours
  • Presented by Donna Taylor
  • + 2 more
  • Next: 17-18 Jan 2023 Live online
  • Also: 17-18 May 2023 Classroom
  • Also: 27-28 Sep 2023 Classroom

Process Validation with Qualification

Live online, Classroom
Focused

Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.

  • 12 CPD hours
  • Presented by Mr Bruce Davis
  • Next: 26 Jan 2023 Live online
  • Also: 8-9 May 2023 Live online
  • Also: 28 Sep 2023 Classroom

Quality Management Refresher

New for 2023

Live online, Classroom
Focused

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.

  • 6 CPD hours
  • Presented by Rob Hughes
  • Next: 16 Mar 2023 Live online
  • Also: 12 Jul 2023 Classroom
  • Also: 6-7 Nov 2023 Live online

Smart Packaging and Electronic Patient Information

New for 2023

Live online, Classroom
Focused

Increased use of SMART technologies has become ever more prevalent in the delivery of healthcare solutions as well as in the electronic delivery of Patient Information (e-PIL) and leaflets (e-leaflets). This course will provide an overview of the current technologies, the patient and societal benefits and some building blocks for the establishment and delivery of e-PIL and SMART strategic initiatives, providing insight as to where organisations may be most significantly impacted.

  • 6 CPD hours
  • Presented by Mr Christopher Waterhouse
  • Next: 14-15 Nov 2022 Live online
  • Also: 6-9 Mar 2023 Live online
  • Also: 13-14 Jul 2023 Classroom
  • Also: 13-14 Nov 2023 Live online

Stability Testing of Pharmaceuticals and Biopharmaceuticals

Live online, Classroom
Focused

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

  • 12 CPD hours
  • Presented by Mr Paul Palmer
  • Next: 20-21 Oct 2022 Live online
  • Also: 2-3 Feb 2023 Classroom
  • Also: 1-2 Jun 2023 Live online
  • Also: 19-20 Oct 2023 Live online

Sterilization of Medical Devices

New for 2022

Live online, Classroom
Focused

Sterile devices are free of viable microorganisms and sterilization is one of the key processes in the production of sterile medical devices. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization is important and expected when demonstrating conformity with the regulations. This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them.

  • 12 CPD hours
  • Presented by Dr Eamonn Hoxey
  • Next: 28-29 Nov 2022 Live online

The Common Technical Document

Live online
Focused

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

  • 12 CPD hours
  • Presented by Hans van Bruggen
  • and Marloes van der Geer
  • Next: 17-18 Nov 2022 Live online

Understanding Active Pharmaceutical Ingredients (APIs) - A Comprehensive and Practical Introduction

New for 2022

Live online
Focused

This course has been designed to provide attendees with a fundamental understanding of best practice and the regulatory environment applicable to active pharmaceutical ingredients in the pharmaceutical industry. It will cover key terminology, the EU and USA regulatory framework, Good Manufacturing Practice (GMP) requirements including controls and validation, and consider Good Distribution Practice (GDP) and how to manage your supply chain.

  • 12 CPD hours
  • Presented by Mr Paul Palmer
  • Next: 28-29 Nov 2022 Live online

Understanding Computer System Validation (CSV) - A Comprehensive and Practical Introduction

New for 2022

Live online
Focused

This course covers the key concepts of computer systems validation and provides practical guidance on how to comply with the regulations applicable to the pharmaceutical industry. It will include the regulatory requirements, the industry standards and best industry practice based on Good Automated Machine Practice (GAMP®5). It will provide a practical and efficient framework for computerised systems validation and compliance, and gives attendees an appreciation of how these ideas may be applied to their own systems and processes.

  • 12 CPD hours
  • Presented by Mr Paul Palmer