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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
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 |
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 |
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 |
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 |
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 |
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.
Typically presented by Mustafa Edik (bio)
| 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 | |
| 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 £450 per attendee | |
| Delivery: collaborative classroom |
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 |
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 |
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 |
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.
Typically presented by Mustafa Edik (bio)
| 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)
| 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 |
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 |
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)
| 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 £800 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 £800 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)
| 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 £800 per attendee | |
| 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)
| Delivery: collaborative classroom |
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.
Rated by attendees to the public programme
Typically presented by Graham Howieson (bio)
| 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 Farah Nadeem (bio) , Paul Palmer (bio)
| Typical duration: 2 days | |
| Pricing from £800 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)
| 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 £800 per attendee | |
| Delivery: collaborative classroom |
The Latest Updates in Good Manufacturing Practices (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.
Typically presented by Mustafa Edik (bio)
| Delivery: collaborative classroom |
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 Farah Nadeem (bio) , Paul Palmer (bio)
| Typical duration: 2 days | |
| Delivery: collaborative classroom |
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 |
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 Farah Nadeem (bio) , Paul Palmer (bio)
| Typical duration: 2 days | |
| Delivery: collaborative classroom |