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In-house & bespoke training:
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
A Practical Introduction to Good Clinical Practice (GCP)
In-house & bespoke training
This highly interactive and practical one-day course will introduce you to both the principles of GCP and give you an understanding of how to practically apply it in different settings.
Typically presented by Sarah Gregory (bio) , Joe Milne (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
An Introduction to Ethylene Oxide (EO) Sterilization for Medical Devices
In-house & bespoke training
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.
Rated by attendees to the public programme
Typically presented by Annette Callaghan (bio)
| Typical duration: Half-day days | |
| Pricing from £350 per attendee | |
| Delivery: collaborative classroom |
An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices
In-house & bespoke training
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.
Typically presented by Annette Callaghan (bio)
| Typical duration: Half-day days | |
| Pricing from £350 per attendee | |
| Delivery: collaborative classroom |
An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices
In-house & bespoke training
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.
Rated by attendees to the public programme
Typically presented by Linda Garrod (bio)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
An Introduction to Pharmaceutical Packaging
In-house & bespoke training
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.
Rated by attendees to the public programme
Typically presented by Chris Penfold (bio)
| Typical duration: 3 days | |
| Pricing from £1,350 per attendee | |
| Delivery: collaborative classroom |
An Introduction to Technology Transfer for Solid Dosage Forms
In-house & bespoke training
This course covers technology transfer for solid dosage forms, focusing on best practices, strategies, and real-world challenges through interactive sessions and case studies.
Typically presented by Laura Buttafoco (bio)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
Balancing Costs and Compliance: The Financial Side of GMP
In-house & bespoke training
Explore how GMP impacts an organisation’s finances – does it hinder innovation and add costs, or unlock potential and boost financial health?
Typically presented by Jitan Bhudia (bio)
| Delivery: collaborative classroom |
Best Practices for Supplier Qualification in Life Science
In-house & bespoke training
Explore the intricacies of Life Science Supplier Qualification through our comprehensive course. Gain expert insights into regulatory compliance, supply chain optimization, and strategic sourcing. Elevate your proficiency in maintaining product integrity with proven industry best practices.
Rated by attendees to the public programme
Typically presented by Mustafa Edik (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products
In-house & bespoke training
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.
Rated by attendees to the public programme
Typically presented by Andrew Willis (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Cleaning Validation - Best Practice in Pharmaceuticals
In-house & bespoke training
Master the principles of cleaning validation to ensure pharmaceutical manufacturing equipment meets stringent regulatory standards, preventing contamination and safeguarding public health.
Typically presented by Mustafa Edik (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Data Integrity and Document Management
In-house & bespoke training
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.
Rated by attendees to the public programme
Typically presented by Laura Brown (bio)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
Data Integrity Auditor Masterclass
In-house & bespoke training
During this course, data integrity will be discussed from the perspective of GxP audits, with practical advice for successful data integrity audits given.
Typically presented by Mustafa Edik (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Development of Combination Products: Critical Interactions
In-house & bespoke training
Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.
Rated by attendees to the public programme
Typically presented by Andrew Willis (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Digital CMC: The Key To Realising Pharma 4.0
In-house & bespoke training
Whether you’re looking to optimise existing processes or lay groundwork for a digital transformation, the course will teach the tools to leverage Digital CMC as a cornerstone of Pharma 4.0 success.
Typically presented by Lewis Shipp (bio)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
Effective Technology Transfer
In-house & bespoke training
The ‘how to’ of technology transfer across the product lifecycle.
Rated by attendees to the public programme
Typically presented by Bruce Davis (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
GMP Principles in Vaccine Manufacturing
In-house & bespoke training
Vaccinology continues to advance and mature impressively, both in developing new and improved vaccines and in administering vaccines to prevent disease. On this course, explore GMP principles in vaccine manufacturing.
Typically presented by Mustafa Edik (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Golden Rules of Being a Successful GMP Auditor
In-house & bespoke training
Learn to conduct thorough audits, identify non-conformities, and recommend corrective actions while following the Golden Rules of successful GMP auditing.
Typically presented by Mustafa Edik (bio)
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Good Distribution Practices of Pharmaceuticals and APIs
In-house & bespoke training
Gain a comprehensive understanding of industry-leading practices, ensuring precision in distribution from manufacturer to end user. Navigate complex supply chains, focus on compliance, and elevate your commitment to quality assurance throughout the entire distribution process.
Rated by attendees to the public programme
Typically presented by Mustafa Edik (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
How to Audit Pharmaceutical Suppliers (Material and Service)
In-house & bespoke training
This training provides knowledge and practical skills to effectively audit material and service providers, covering key areas including raw materials, contract manufacturing, logistics, and packaging.
Typically presented by Mustafa Edik (bio)
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
How to Deal with Difficult Situations in GMP Audits
In-house & bespoke training
This training equips auditors with strategies to handle obstacles such as documentation errors, unethical behaviours, resistance, and time-wasting tactics, ensuring a smooth and productive audit process.
Typically presented by Mustafa Edik (bio)
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
How to Interview During GMP Audits
In-house & bespoke training
One of the most valuable tools for auditors in the pharmaceutical industry is the ability to conduct thorough and effective interviews during audits. This training will equip you with these essential skills.
Typically presented by Mustafa Edik (bio)
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
How to Manage Internal GMP Audits
In-house & bespoke training
This training programme provides essential skills for planning, managing, and executing internal Good Manufacturing Practices (GMP) audits.
Typically presented by Mustafa Edik (bio)
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
How to Pass International Health Authority Inspections
In-house & bespoke training
This training course prepares professionals in pharmaceuticals, healthcare, and manufacturing to navigate regulatory inspections by major health authorities including the FDA, MHRA, WHO, and EMA.
Typically presented by Mustafa Edik (bio)
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
How to Perform Bullet-Proof Good Distribution Practices (GDP) and Good Storage Practices (GSP) Audits
In-house & bespoke training
This training will equip attendees with the practical skills necessary to implement regulatory-compliant distribution and storage systems, ensuring both pharmaceutical integrity and patient safety.
Typically presented by Mustafa Edik (bio)
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
ICH Q9(R1) Quality Risk Management (QRM)
In-house & bespoke training
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.
Typically presented by Bruce Davis (bio)
| Typical duration: Half-day days | |
| Pricing from £350 per attendee | |
| Delivery: collaborative classroom |
In the Light of Annex 1: Use of Barrier Systems for Aseptic Pharmaceutical Manufacturing
In-house & bespoke training
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.
Rated by attendees to the public programme
Typically presented by Lukas Munzinger (bio)
| Delivery: collaborative classroom |
Making Financial Sense of GMP: Change Management
In-house & bespoke training
In this talk, explore how change management impacts the financials of an organisation and how well-managed change management can enhance an organisation's financial strength.
Typically presented by Jitan Bhudia (bio)
| Delivery: collaborative classroom |
Making Financial Sense of GMP: Pharmaceutical Quality System (PQS)
In-house & bespoke training
In this talk, explore how the Pharmaceutical Quality System (PQS) impacts the financials of an organisation and how it can enhance an organisation's financial strength.
Typically presented by Jitan Bhudia (bio)
| Delivery: collaborative classroom |
Making Financial Sense of GMP: Quality Risk Management (QRM)
In-house & bespoke training
In this talk, explore how the Quality Risk Management (QRM) impacts the financials of an organisation and how it can enhance an organisation's financial strength.
Typically presented by Jitan Bhudia (bio)
| Delivery: collaborative classroom |
Making Financial Sense of GMP: Validation Master Plan (VMP)
In-house & bespoke training
In this talk, explore how the Validation Master Plan (VMP) impacts the financials of an organisation and discover how a well managed VMP enhances an organisation’s financial strength.
Typically presented by Jitan Bhudia (bio)
| Delivery: collaborative classroom |
Medical Device Single Audit Programme (MDSAP)
In-house & bespoke training
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.
Rated by attendees to the public programme
Typically presented by Stuart Angell (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Molecule to Medicine: An Introduction to the ‘Soft Side’ of Technology Transfers
In-house & bespoke training
The ability to create a working relationship with your partners in a technology transfer is normally overlooked. In the current pharmaceutical landscape, gaining trust should never be an after thought.
Typically presented by Laura Buttafoco (bio)
| Delivery: collaborative classroom |
Molecule to Medicine: An Introduction to Upstream and Downstream Manufacturing in the Biopharmaceutical Industry
In-house & bespoke training
In this talk, explore the fundamental concepts, techniques, and processes that make up the backbone of biomanufacturing, pharmaceutical production, and biotechnology.
Typically presented by Mustafa Edik (bio)
| Delivery: collaborative classroom |
Navigating China’s API Regulations: An Essential Guide to DMF Registration
In-house & bespoke training
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.
| Typical duration: 90-minutes days | |
| Pricing from £200 per attendee | |
| Delivery: collaborative classroom |
Navigating Risk and Compliance in Pharma: Change Control, Manufacturing and Supply Operations
In-house & bespoke training
Master the essentials of change control in pharmaceutical manufacturing to ensure quality and regulatory compliance. Discover key processes, change types, and industry regulations to maintain high standards.
Typically presented by Gurpal Singh (bio)
| Delivery: collaborative classroom |
Navigating Risk and Compliance in Pharma: Effectively Managing Deviations
In-house & bespoke training
Master the management of pharmaceutical deviations to ensure product quality, safety, and compliance. Discover key steps, industry best practices, and regulatory requirements to prevent risks and drive continuous improvement.
Typically presented by Gurpal Singh (bio)
| Delivery: collaborative classroom |
Navigating Risk and Compliance in Pharma: Storage and Distribution Compliance
In-house & bespoke training
Discover how regulatory compliance and best practices in pharmaceutical storage and distribution ensure safe, effective medicines, with a focus on the vital role of 3PL suppliers in optimising supply chain efficiency.
Typically presented by Gurpal Singh (bio)
| Delivery: collaborative classroom |
New EU GMP Annex 1 and its Impact on Pharmaceutical Manufacturers
In-house & bespoke training
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.
Rated by attendees to the public programme
Typically presented by Mustafa Edik (bio)
| Delivery: collaborative classroom |
New EU GMP Annex 1: Compliant Aseptic Operations
In-house & bespoke training
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.
Typically presented by Mustafa Edik (bio)
| Typical duration: 3 days | |
| Pricing from £1,350 per attendee | |
| Delivery: collaborative classroom |
Pharmaceutical Development of ATMPs
In-house & bespoke training
This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.
Rated by attendees to the public programme
Typically presented by Andrew Willis (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Practical Implementation of GCP in Veterinary Field Studies
In-house & bespoke training
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.
Rated by attendees to the public programme
Typically presented by Rachel Anderson (bio) , Donna Taylor (bio) , Jenny Webster (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Process Validation for Medical Devices
In-house & bespoke training
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.
Typically presented by Mustafa Edik (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Process Validation with Qualification
In-house & bespoke training
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.
Rated by attendees to the public programme
Typically presented by Bruce Davis (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Responsible Conduct of Research (RCR): Good Clinical Practice (GCP)
In-house & bespoke training
This course covers Good Clinical Practice (GCP) principles, ensuring participants understand the ethical and regulatory foundations of clinical research, including integrity, safety, consent, data management, and compliance.
Typically presented by Samaa Al Tabbah (bio)
| Delivery: collaborative classroom |
Responsible Conduct of Research (RCR): Good Documentation Practice (GDocP)
In-house & bespoke training
Documentation is crucial for regulatory compliance, ensuring accuracy and integrity in clinical trials and laboratory work. GDP has evolved over time, guided by ALCOA & ALCOA-plus principles.
Typically presented by Samaa Al Tabbah (bio)
| Delivery: collaborative classroom |
Responsible Conduct of Research (RCR): Good Publication Practice (GPP)
In-house & bespoke training
This course will look at ethical research, responsible authorship, and data integrity while addressing conflicts, misconduct, and copyright issues.
Typically presented by Samaa Al Tabbah (bio)
| Delivery: collaborative classroom |
Responsible Conduct of Research (RCR): Good Writing Practice (GWP)
In-house & bespoke training
This course covers ethical standards, data integrity, audience tailoring, document structure, clarity, consistency, citation, and tools for quality control and compliance.
Typically presented by Samaa Al Tabbah (bio)
| Delivery: collaborative classroom |
Robotics and Digitalization in Aseptic Pharmaceutical Manufacturing
In-house & bespoke training
This free webinar will provide an essential overview of robotics and digitalization in aseptic pharmaceutical manufacturing.
Rated by attendees to the public programme
Typically presented by Daniel Sturm (bio)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
Smart Packaging and Electronic Patient Information
In-house & bespoke training
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.
Rated by attendees to the public programme
Typically presented by Graham Howieson (bio)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
Stability Testing of Pharmaceuticals and Biopharmaceuticals
In-house & bespoke training
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.
Rated by attendees to the public programme
Typically presented by Paul Palmer (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Sterilization of Medical Devices
In-house & bespoke training
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.
Rated by attendees to the public programme
Typically presented by Annette Callaghan (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
The Common Technical Document
In-house & bespoke training
A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.
Rated by attendees to the public programme
Typically presented by Andrew Willis (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
The Latest Updates in Global GMP
In-house & bespoke training
In this free 90-minute webinar, you will gain an insight into the latest updates in GMP, as well as consolidating your existing knowledge on the subject.
Rated by attendees to the public programme
Typically presented by Mustafa Edik (bio)
| Delivery: collaborative classroom |
Thinking Outside of the GMP Box
In-house & bespoke training
In this two-day course, you will be able to gain a whole new perspective on GMP requirements, including how to implement them.
Typically presented by Mustafa Edik (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Understanding Active Pharmaceutical Ingredients (APIs)
In-house & bespoke training
This course 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.
Typically presented by Paul Palmer (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Understanding Computer System Validation (CSV)
In-house & bespoke training
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.
Rated by attendees to the public programme
Typically presented by Paul Palmer (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |