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

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.

Typically presented by Annette Callaghan (bio)

Delivery: collaborative classroom

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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)

Delivery: collaborative classroom

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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.

Typically presented by Stuart Angell (bio)

Delivery: collaborative classroom

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An Introduction to ISO 22716 - GMP for Cosmetic Products

In-house & bespoke training

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.


Typically presented by Mustafa Edik (bio)

Delivery: collaborative classroom

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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: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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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
Delivery: collaborative classroom

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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 £450 per attendee
Delivery: collaborative classroom

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Data Integrity Auditor Master Class

In-house & bespoke training

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.

Typically presented by Mustafa Edik (bio)

Delivery: collaborative classroom

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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 £800 per attendee
Delivery: collaborative classroom

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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 £800 per attendee
Delivery: collaborative classroom

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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)

Delivery: collaborative classroom

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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.

Typically presented by Lukas Munzinger (bio)

Delivery: collaborative classroom

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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)

Delivery: collaborative classroom

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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.

Typically presented by Raymond Ng (bio) , Helen Ye (bio)

Delivery: collaborative classroom

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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

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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)

Delivery: collaborative classroom

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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 £800 per attendee
Delivery: collaborative classroom

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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 £800 per attendee
Delivery: collaborative classroom

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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 Stuart Angell (bio)

Delivery: collaborative classroom

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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 £800 per attendee
Delivery: collaborative classroom

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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)

Delivery: collaborative classroom

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Smart Packaging and Electronic Patient Information

In-house & bespoke training

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.

Typically presented by Graham Howieson (bio)

Delivery: collaborative classroom

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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 £800 per attendee
Delivery: collaborative classroom

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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)

Delivery: collaborative classroom

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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 £800 per attendee
Delivery: collaborative classroom

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Understanding Active Pharmaceutical Ingredients (APIs)

In-house & bespoke training

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.

Typically presented by Paul Palmer (bio)

Typical duration: 2 days
Delivery: collaborative classroom

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Understanding and Interpreting the Proposed Changes to EU GMP Annex 11

In-house & bespoke training

This half-day course will provide an essential update on the proposed changes to EU GMP Annex 11 and will enhance delegate's understanding of the implications on working practices, as well as including a control framework for AI and ML.

Typically presented by Bob McDowall (bio)

Typical duration: 1 day
Delivery: collaborative classroom

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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. 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.

Rated by attendees to the public programme

Typically presented by Paul Palmer (bio)

Typical duration: 2 days
Delivery: collaborative classroom

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It was excellent

Mfanafuthi Mbali, Production manager, NBI

Very useful, exhaustive and easy to understand and follow

Marco Marzulli, MES deployment Internship , MERCK SERONO

Very good

Jeļena Gurko, Leading Industrial Pharmacist, JSC

I thought it was overall a very good course that I would recommend people to take.

Marte Sønnervik, Clinical Study Coordinator, PHARMAQ

I'm very delighted with the course, the presentation and the speakers.

Cuong Nguyen, Associate Specialist, Clinical Research, MSD Animal Health Innovation GmbH

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

The course was very informative and the speaker explained the content very well.

Laura Sukacz, Quality Operations Officer, Kent Pharma UK Ltd

The course was very informative and the speaker explained the content very well. I've also liked that all relevant guidelines have been included in the slides.

Laura Sukacz, Quality Operations Officer, Kent Pharma UK Ltd

I really enjoyed the course and Rachel, Jenny and Donna were wonderfully engaging presenter and given us lots of opportunity to ask the questions. The course was mix of theory & few practical exercises. I took away lots of things which I can easily apply at my work .

Kritika Sengar Chauhan, Associate Specialist, Clinical Research, MSD Animal Health Innovation GmbH

Bruce seemed very knowledgeable thanks to all his years working within the industry.

Andrés Bueno Venegas, Scientific consultant, Emendo R&D