Scheduled In-house

GxP Training Courses

We offer a range of essential GxP (Good x Practice) compliance training courses across a variety of areas to ensure you comply with the regulations and quality guidelines.

GxP 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 provide GxP training for the pharmaceutical, medical device, animal health and cosmetics industries, covering, manufacture, laboratory, distribution and clinical good practices. Focused topics include Quality Management Systems, Packaging and Labelling, Computer System Validation and the role of the Qualifed Person and Responsible Person. Staying constantly up-to-date with changes in requirements can be challenging, so keep abreast of changes and their implications on good practices by attending our extensive training series.

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  • Next: 29 Feb-1 Mar 2024 Live online
  • Also: 27-28 Jun 2024 Live online
  • Also: 17-18 Oct 2024 Live online

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

Live online

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 Focused
  • Presented by Andrew Willis
  • Next: 12-13 Mar 2024 Live online
  • Also: 2-3 Jul 2024 Live online
  • Also: 25-26 Nov 2024 Live online

The Common Technical Document

Live online

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

  • 12 CPD hours Focused
  • Presented by Hans van Bruggen
  • and Marloes van der Geer
  • Next: 12 Apr 2024 Live online
  • Also: 22 Jul 2024 Live online
  • Also: 6 Dec 2024 Live online

Data Integrity and Document Management

Live online

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 Focused
  • Presented by Dr Laura Brown
  • Next: 30-31 Jan 2024 Live online
  • Also: 30 Apr-1 May 2024 Live online
  • Also: 24-25 Jul 2024 Live online
  • Also: 16-17 Oct 2024 Live online

Data Integrity Auditor Master Class

New for 2024

Live online

During this course data integrity will be discussed from the perspective of GxP audits, and practical advice for successful data integrity audits will be provided. Important guidance about data integrity concepts and guidelines will be covered, and the skills required by personnel performing the audits will be discussed.

  • 12 CPD hours Focused
  • Presented by Mustafa Edik
  • Next: 12-13 Feb 2024 Live online
  • Also: 25-26 Jun 2024 Live online
  • Also: 7-10 Oct 2024 Live online

Development of Combination Products: Critical Interactions

Live online

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

  • 12 CPD hours Focused
  • Presented by Andrew Willis
  • Next: 23-24 Jan 2024 Live online
  • Also: 16-17 Apr 2024 Classroom
  • Also: 16-17 Jul 2024 Live online
  • Also: 7-8 Oct 2024 Classroom

Effective Technology Transfer

Live online, Classroom

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

  • 12 CPD hours Focused
  • Presented by Bruce Davis
  • Next: 31 Jan 2024 Live online
  • Also: 1 May 2024 Live online
  • Also: 25 Sep 2024 Live online

ICH Q9(R1) Quality Risk Management (QRM)

New for 2024

Live online

ICH Q9(R1) Quality Risk Management has recently been updated by the regulators. This training course will bring participants right up-to-date with the latest Q9(R1) requirements. It will explain the changes and give context as to how these impact pharmaceutical products and processes. It will cover a range of product types and situations.

  • Presented by Bruce Davis
  • Next: 6 Mar 2024 Live online

In the Light of Annex 1: Use of Barrier Systems for Aseptic Pharmaceutical Manufacturing

Free

Live online

This free webinar will familiarise attendees with Restricted Access Barrier System (RABS) technologies. An excellent opportunity to receive detailed information about barrier systems with a main focus on isolator technology, particularly since the implementation of EU GMP Annex 1.

  • 1.5 CPD hours High impact
  • Presented by Lukas Munzinger
  • Next: 1 May 2024 Live online
  • Also: 11 Nov 2024 Live online

An Introduction to Ethylene Oxide (EO) Sterilization for Medical Devices

New for 2024

Live online

Sterile devices are free of viable microorganisms and EO sterilization is one of the key processes in the production of sterile medical devices. This course provides an introduction to the regulatory requirements as they relate to EO sterilisation and how manufacturers may demonstrate compliance.

  • 3 CPD hours
  • Presented by Annette Callaghan
  • Next: 21 May 2024 Live online
  • Also: 18 Nov 2024 Live online

An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices

New for 2024

Live online

Sterile devices are free of viable microorganisms and the sterile barrier system is the key to maintaining this sterility until the medical device is ready to be used on a patient. This course provides an introduction to the regulatory requirements as they relate to typical sterile barrier systems used for single-use and reusable medical devices, and how manufacturers may demonstrate compliance.

  • 3 CPD hours
  • Presented by Annette Callaghan
  • Next: 6 Mar 2024 Live online
  • Also: 4 Jul 2024 Classroom
  • Also: 20 Nov 2024 Live online

An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices

New for 2024

Live online, Classroom

This course has been specifically designed to provide an essential introduction to ISO 13485 and the QMS and provides a comprehensive and valuable overview of the requirements and responsibilities involved. Where ever you and your company sit within the medical device arena this is an excellent opportunity to become appraised of the requirements.

  • 6 CPD hours Focused
  • Presented by Stuart Angell
  • Next: 19-20 Mar 2024 Live online
  • Also: 17-18 Jul 2024 Live online
  • Also: 19-22 Nov 2024 Live online

An Introduction to ISO 22716 - GMP for Cosmetic Products

New for 2024

Live online

This course will provide an essential overview of GMP in the production and manufacture of cosmetics. It will be particularly useful for Pharmaceutical and Biotech companies considering entering this market and it will also provide an opportunity for those who need to refresh their knowledge about the requirements.

  • 12 CPD hours Focused
  • Presented by Mustafa Edik
  • Next: 30 Jan-1 Feb 2024 Live online
  • Also: 20-22 May 2024 Live online
  • Also: 25-27 Sep 2024 Classroom

An Introduction to Pharmaceutical Packaging

Live online, Classroom

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 Focused
  • Presented by Chris Penfold
  • Next: 25-26 Mar 2024 Live online
  • Also: 4-5 Jul 2024 Live online
  • Also: 28-29 Nov 2024 Live online

Medical Device Single Audit Programme (MDSAP)

Live online

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 Focused
  • Presented by Stuart Angell
  • Next: 1 Feb 2024 Live online

Navigating China’s API Regulations: An Essential Guide to DMF Registration

New for 2024

Live online

Enhance your knowledge of the regulatory requirements for Active Pharmaceutical Ingredients and the Drug Master File in China. An opportunity to learn the quickest pathway options for DMF registration and to hear from industry leaders in this important region.

  • 1.5 CPD hours
  • Presented by Raymond Ng
  • and Helen Ye
  • Next: 12-14 Mar 2024 Live online
  • Also: 2-4 Jul 2024 Live online
  • Also: 26-28 Nov 2024 Live online

New EU GMP Annex 1: Compliant Aseptic Operations

New for 2024

Live online

Maintaining a sterile production environment on an ongoing basis is critical in the production of sterile pharmaceuticals, and strict adherence to guidelines and relevant standards is required to minimize contamination risks and ensure product quality and safety. During this training, all changes in Annex 1 will be evaluated, and the minimum requirements that aseptic operations must meet will be discussed and presented to the participants through examples.

  • 18 CPD hours
  • Presented by Mustafa Edik
  • Next: 5-8 Feb 2024 Live online
  • Also: 18-19 Jun 2024 Live online
  • Also: 14-15 Oct 2024 Live online

Pharmaceutical Development of ATMPs

Live online

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

  • 12 CPD hours Focused
  • Presented by Andrew Willis
  • Next: 19-20 Mar 2024 Live online
  • Also: 26-27 Nov 2024 Classroom

Practical Implementation of GCP in Veterinary Field Studies

Live online, Classroom

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 Focused
  • Presented by Donna Taylor
  • and Jenny Webster
  • Next: 7-8 Feb 2024 Live online
  • Also: 5-6 Jun 2024 Classroom
  • Also: 15-16 Oct 2024 Live online

Process Validation for Medical Devices

New for 2024

Live online, Classroom

This course focuses on the Regulatory and Quality Management System links to Process Validation for medical devices, and reviews the Installation Qualification, Operation Qualification and Performance Qualification Processes and how these fit with regulatory needs and technical documentation.

  • 12 CPD hours
  • Presented by Stuart Angell
  • Next: 16-17 Jan 2024 Live online
  • Also: 21-22 May 2024 Live online
  • Also: 23-24 Sep 2024 Classroom

Process Validation with Qualification

Live online, Classroom

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 Focused
  • Presented by Bruce Davis
  • Next: 14 Feb 2024 Live online

Robotics and Digitalization in Aseptic Pharmaceutical Manufacturing

Free

Live online

This free webinar will provide an essential overview of robotics and digitalization in aseptic pharmaceutical manufacturing.

  • 1.5 CPD hours High impact
  • Presented by Daniel Sturm
  • Next: 14 Mar 2024 Live online
  • Also: 10 Jul 2024 Live online
  • Also: 4-5 Nov 2024 Live online

Smart Packaging and Electronic Patient Information

New for 2024

Live online

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 Focused
  • Presented by Graham Howieson
  • Next: 4-7 Mar 2024 Live online
  • Also: 11-12 Jul 2024 Live online
  • Also: 11-12 Nov 2024 Live online

Stability Testing of Pharmaceuticals and Biopharmaceuticals

Live online

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 Focused
  • Presented by Paul Palmer
  • Next: 1-2 Feb 2024 Live online
  • Also: 6-7 Jun 2024 Live online
  • Also: 17-18 Oct 2024 Live online

Sterilization of Medical Devices

Live online

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 Focused
  • Presented by Annette Callaghan
  • Next: 13-14 Mar 2024 Live online
  • Also: 17-18 Jul 2024 Live online
  • Also: 18-19 Nov 2024 Live online

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

Live online

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 Focused
  • Presented by Paul Palmer
  • Next: 19-20 Mar 2024 Live online
  • Also: 24-25 Jul 2024 Live online
  • Also: 25-26 Nov 2024 Live online

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

Live online

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 Focused
  • Presented by Paul Palmer
  • Recorded webcast

New EU GMP Annex 1 and its Impact on Pharmaceutical Manufacturers

Free

Recorded webcast

This free webinar will explain the reasons for the revision of Annex 1 and will address the changes and implications for pharmaceutical manufacturers. Topics to be covered will include how to prepare your Contamination Control Strategy (CCS) document, and how to adapt to the principles of Quality Risk Management. The expectations of the regulatory authorities and the questions that may be encountered in audits/inspections will also be discussed.

  • 1.5 CPD hours High impact
  • Presented by Mustafa Edik