Management Forum courses now available at IPI Academy - visit IPI for an updated experience and a broader selection of courses and subjects

In-house & bespoke training:
GxP

GxP (Good x Practice) 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 offer a range of essential GxP training across a variety of areas to ensure you comply with the regulations and quality guidelines.

 

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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An Introduction to Quality Management for Managers

In-house & bespoke training

This seminar has been designed to provide a highly interactive introduction to Quality Management for managers and will provide the opportunity to share and consolidate the key elements of the Pharmaceutical Quality System (PQS). It will provide practical advice and guidance on how to ensure legal and operational responsibilities are fulfilled.

Typically presented by Rob Hughes (bio)

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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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 David Howlett (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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GMP Fundamentals

In-house & bespoke training

This two-day seminar will consider the relationship between the legal requirements for pharmaceutical manufacture, the PQS and the delivery of GMP. It will provide a highly interactive session to discuss the key elements of the PQS and the relationship with GMP as described in the “Orange Guide”, including the practical application of GMP in manufacturing and quality control.

Typically presented by Rob Hughes (bio)

Typical duration: 2 days
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.

Typically presented by Eamonn Hoxey (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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Pharmaceutical Packaging, Labelling and Artwork Origination

In-house & bespoke training

This course has been designed to present a number of important developments in pharmaceutical packaging and labelling from regulations, standardisation and technology to innovation and artwork origination.

Rated by attendees to the public programme

Typically presented by George Barrie (bio)
and 6 more leading experts

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 Tamsin Dawson (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 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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Quality Management Refresher

In-house & bespoke training

This seminar has been designed to provide a highly interactive session to refresh key personnel in the principles and practices of Quality Management and bring them up-to-date with the latest legal requirements. The seminar will review the key elements of the Pharmaceutical Quality System (PQS) and the roles and responsibilities of all staff involved in the PQS, including management.
It will also provide a comprehensive overview of the essential principles and requirements of "The Orange Guide” and other relevant regulatory requirements.

Typically presented by Rob Hughes (bio)

Typical duration: 1 day
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 Christopher Waterhouse (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.

Typically presented by Eamonn Hoxey (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 Hans van Bruggen (bio) , Marloes van der Geer (bio)

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

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Overall, I would recommend the webinar to people who are starting a career in clinical trials as it gives a good overview of all aspects of GCP.

Laure Bidois, Senior Advisor Regulatory Affairs, knoell

It was a very useful training that fulfil my necessities about the Industry standards for the Technology transfers... Bruce is very knowledgeable and he was continuously asking the participants to provide feedback and their own experiences.

Sergio Molina Zaragoza, Vice President Research and Development, Grifols Biologicals LLC

Very engaging with lots of examples to ease understanding.

Kirsty Brown, Scientist II, Thermo Fisher Scientific

Everything set in the agenda was covered. No issues with presentation, if any help required we were able to privately message Natalia. The speed at which Bruce spoke through the documents was good and I was happy there was multiple opportunities to make comments, discuss topic and conduct exercises on what we just learnt.

Amaira Umer, QA Officer, Purolite Ltd

A very well rounded course that formalised and expanded on a lot of knowledge/understanding that we were in the process of developing ourselves. The course contains a lot of brilliant insights into the issues with tech transfer process and how to effectively manage these issues with adequate planning, controls and communication. Overall I was very impressed with the course and Bruce, and would recommend anyone involved in a process where methods/tech are being transferred to sign up to this course.

Emir Bouleghlimat, , Purolite Ltd

The course contains a lot of brilliant insights into the issues with tech transfer process and how to effectively manage these issues with adequate planning, controls and communication.

Emir Bouleghlimat, , Purolite Ltd

It was a well done webinar, the speakers were very competent and experienced. The content was informative

Helena Metzker, Clinical Research Associate, MSD Animal Health Innovation

I was hoping to achieve more knowledge about combination product and the regulatory documentations needed for the market authorisation and this was completely accomplished.

Greta Ferrari, Analytical Scientist, Chiesi Farmaceutici

I learned a lot about Risk Qualification and Validation. It helps me understand my role in Facilities Qualification.

Morady Som, Facilities Qualification , Cepheid

Bruce was very polite and interactive. The use of real-life examples, I thought was great to help apply and understand certain points.

Liam Evans , , Purolite Ltd