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
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.
An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices Training Course
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.
An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices Training Course
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.
An Introduction to ISO 22716 - GMP (Good Manufacturing Practice) for Cosmetic Products Training Course
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.
An Introduction to Pharmaceutical Packaging Training Course
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.
Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products Training Course
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.
Data Integrity and Document Management Training Course
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.
Data Integrity Auditor Master Class Training Course
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.
Development of Combination Products: Critical Interactions Training Course
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.
Effective Technology Transfer Training Course
ICH Q9(R1) Quality Risk Management (QRM) Training Course
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.
In the Light of Annex 1: Use of Barrier Systems for Aseptic Pharmaceutical Manufacturing Training Course
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.
Medical Device Single Audit Programme (MDSAP) Training Course
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.
Navigating China’s API Regulations: An Essential Guide to DMF Registration Training Course
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.
New EU (European Union) GMP (Good Manufacturing Practice) Annex 1: Compliant Aseptic Operations Training Course
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.
Pharmaceutical Development of ATMPs Training Course
Practical Implementation of GCP (Good Clinical Practice) in Veterinary Field Studies Training Course
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.
Process Validation for Medical Devices Training Course
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.
Process Validation with Qualification Training Course
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.
Robotics and Digitalization in Aseptic Pharmaceutical Manufacturing Training Course
14 Feb 2024 - Online webinar
This free webinar will provide an essential overview of robotics and digitalization in aseptic pharmaceutical manufacturing.
Smart Packaging and Electronic Patient Information Training Course
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.
Stability Testing of Pharmaceuticals and Biopharmaceuticals Training Course
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.
Sterilization of Medical Devices Training Course
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.
The Common Technical Document Training Course
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.
Understanding Active Pharmaceutical Ingredients (APIs) Training Course
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.
Understanding Computer System Validation (CSV) Training Course
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.