Training courses & Webinars:
GxP

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.

 

Please note: full product details will be shown on our training portal IPI Academy where you can find out more and book

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

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

1 May 2024 - Online webinar
Also on: 11 Nov 2024

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.

Presented by Annette Callaghan (bio)

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

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

21 May 2024 - Online webinar
Also on: 18 Nov 2024

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.

Presented by Annette Callaghan (bio)

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

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

6 Mar 2024 - Online webinar
Also on: 4 Jul 2024

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.

Presented by Stuart Angell (bio)

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An Introduction to ISO 22716 - GMP (Good Manufacturing Practice) for Cosmetic Products Training Course

An Introduction to ISO 22716 - GMP for Cosmetic Products

19-20 Mar 2024 - Online webinar
Also on: 17 Jul 2024

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.


Presented by Mustafa Edik (bio)

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An Introduction to Pharmaceutical Packaging Training Course

An Introduction to Pharmaceutical Packaging

30 Jan-1 Feb 2024 - Online webinar
Also on: 20 May 2024

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.

Presented by Chris Penfold (bio)

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

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

29 Feb-1 Mar 2024 - Online webinar
Also on: 27 Jun 2024

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.

Presented by Andrew Willis (bio)

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Data Integrity and Document Management Training Course

Data Integrity and Document Management

12 Apr 2024 - Online webinar
Also on: 22 Jul 2024

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.

Presented by Laura Brown (bio)

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Data Integrity Auditor Master Class Training Course

Data Integrity Auditor Master Class

30-31 Jan 2024 - Online webinar
Also on: 30 Apr 2024

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.

Presented by Mustafa Edik (bio)

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Development of Combination Products: Critical Interactions Training Course

Development of Combination Products: Critical Interactions

12-13 Feb 2024 - Online webinar
Also on: 25 Jun 2024

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

Presented by Andrew Willis (bio)

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Effective Technology Transfer Training Course

Effective Technology Transfer

23-24 Jan 2024 - Online webinar
Also on: 16 Apr 2024

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

Presented by Bruce Davis (bio)

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ICH Q9(R1) Quality Risk Management (QRM) Training Course

ICH Q9(R1) Quality Risk Management (QRM)

31 Jan 2024 - Online webinar
Also on: 1 May 2024

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 (bio)

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

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

6 Mar 2024 - Online webinar

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.

Presented by Lukas Munzinger (bio)

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Medical Device Single Audit Programme (MDSAP) Training Course

Medical Device Single Audit Programme (MDSAP)

30 Nov-1 Dec 2023 - Online webinar
Also on: 25 Mar 2024

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.

Presented by Stuart Angell (bio)
Linda Garrod (bio)

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

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

1 Feb 2024 - Online webinar

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.

Presented by Raymond Ng (bio)
Helen Ye (bio)

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New EU (European Union) GMP (Good Manufacturing Practice) Annex 1: Compliant Aseptic Operations Training Course

New EU GMP Annex 1: Compliant Aseptic Operations

12-14 Mar 2024 - Online webinar
Also on: 2 Jul 2024

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.

Presented by Mustafa Edik (bio)

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Pharmaceutical Development of ATMPs Training Course

Pharmaceutical Development of ATMPs

5-8 Feb 2024 - Online webinar
Also on: 18 Jun 2024

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

Presented by Andrew Willis (bio)

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Practical Implementation of GCP (Good Clinical Practice) in Veterinary Field Studies Training Course

Practical Implementation of GCP in Veterinary Field Studies

19-20 Mar 2024 - Online webinar
Also on: 26 Nov 2024

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.

Presented by Donna Taylor (bio)
Jenny Webster (bio)

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Process Validation for Medical Devices Training Course

Process Validation for Medical Devices

7-8 Feb 2024 - Online webinar
Also on: 5 Jun 2024

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.

Presented by Stuart Angell (bio)

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Process Validation with Qualification Training Course

Process Validation with Qualification

16-17 Jan 2024 - Online webinar
Also on: 21 May 2024

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.

Presented by Bruce Davis (bio)

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Robotics and Digitalization in Aseptic Pharmaceutical Manufacturing Training Course

Robotics and Digitalization in Aseptic Pharmaceutical Manufacturing

14 Feb 2024 - Online webinar

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

Presented by Daniel Sturm (bio)

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Smart Packaging and Electronic Patient Information Training Course

Smart Packaging and Electronic Patient Information

14 Mar 2024 - Online webinar
Also on: 10 Jul 2024

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.

Presented by Graham Howieson (bio)

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Stability Testing of Pharmaceuticals and Biopharmaceuticals Training Course

Stability Testing of Pharmaceuticals and Biopharmaceuticals

4-7 Mar 2024 - Online webinar
Also on: 11 Jul 2024

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.

Presented by Paul Palmer (bio)

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Sterilization of Medical Devices Training Course

Sterilization of Medical Devices

1-2 Feb 2024 - Online webinar
Also on: 6 Jun 2024

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.

Presented by Annette Callaghan (bio)

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The Common Technical Document Training Course

The Common Technical Document

12-13 Mar 2024 - Online webinar
Also on: 2 Jul 2024

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

Presented by Hans van Bruggen (bio)
Marloes van der Geer (bio)

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Understanding Active Pharmaceutical Ingredients (APIs) Training Course

Understanding Active Pharmaceutical Ingredients (APIs)

13-14 Mar 2024 - Online webinar
Also on: 17 Jul 2024

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.

Presented by Paul Palmer (bio)

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Understanding Computer System Validation (CSV) Training Course

Understanding Computer System Validation (CSV)

19-20 Mar 2024 - Online webinar
Also on: 24 Jul 2024

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.

Presented by Paul Palmer (bio)

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The content of the webinar was good, thorough. Paul answered any questions which I asked. With clear and concise reasoning. He made it easy to follow and not boring for someone with 4 years stability testing experience and basic knowledge. This has given me the tools I need to go back and hopefully improve the stability studies for the future. I enjoyed, I feel like I'm better prepared to justify the requirements of a stability study to my company. With an understanding of how to reduce costs and apply it to the industry I am in.

Elinor Jarvis, Quality Control Team Supervisor, Purolite Ltd

Good speaker and content was very well explained. It met absolutely all my expectations.

Carmen Lopez, SCIENTIST, IMMUNOCORE

Paul gave a very informative and interactive course. He made the learning enjoyable, and it was obvious how knowledgeable he was.

Brid Hogan, R&D Project associate, Teva Pharmaceuticals Europe BV

My overall opinion is that this course was very worthwhile and well taught. I feel as though I learned a lot but I have learned in a way in which I will be able to apply this knowledge confidently to my job.

Rachel Power, R&D Project Technician, Teva Pharmaceuticals Europe BV

Laura Brown's webinar gave me more confident in data integrity she presented all the necessary information to gain my confident. I really appreciate it.

Kheira Heddi, Quality Assurance Officer, SGSUK

Training materials were detailed and easy to follow. Trainer was engaged and made sure that contents were delivered in a way that the Trainees could relate to.

Esther Okeudo, QA Specialist, JenaValve

Good, well presented and full of information and knowledge

Iti Sharma, QA Assosiate, Nox Medical

The content was very useful for my daily work. The presentation was well prepared and the speaker made it easy to listen online.

Christiane Rederath, Clinical Research Associate, MSD Animal Health Innovation GmbH

I certainly have more information after the webinar which set a good foundation for further research. I liked the biopharmaceuticals topics and the packaging slides. These were of particular interest to me. I liked the idea of breakout rooms. A good amount of material was covered over the two days and I enjoyed the idea of breaking up the presentations with exercises.

Ananthi Ramachandran, Quality Control Manager , Rentschler ATMP Limited

The speaker was very good, the slides were clear and the explanations exhaustive.

Chiara Giaconi, Global Regulatory Affairs Oncology CMC Manager, Menarini Ricerche S.p.A.