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Training courses & Webinars:
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
13-14 Jun 2022 - Online webinar
Also on: 28 Sep 2022
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.
Presented by Chris Penfold (bio)
An Introduction to Quality Management for Managers
15 Jun 2022 - Online webinar
Also on: 15 Sep 2022
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.
Presented by Rob Hughes (bio)
Common Technical Document
28-29 Nov 2022 - Online webinar
A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.
Data Integrity and Document Management
7 Jul 2022 - Online webinar
Also on: 10 Oct 2022
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.
Presented by Laura Brown (bio)
Development of Combination Products: Critical Interactions
7-8 Nov 2022 - Online webinar
Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.
Presented by David Howlett (bio)
Effective Technology Transfer
4-5 Jul 2022 - Online webinar
Also on: 11 Oct 2022
The ‘how to’ of technology transfer across the product lifecycle
Presented by Bruce Davis (bio)
GMP Fundamentals
30 Jun-1 Jul 2022 - Online webinar
Also on: 18 Oct 2022
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.
Presented by Rob Hughes (bio)
Medical Device Single Audit Programme (MDSAP)
7-8 Jul 2022 - Online webinar
Also on: 1 Dec 2022
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.
Presented by Eamonn Hoxey (bio)
Pharmaceutical Development of ATMPs
14-15 Jul 2022 - Online webinar
Also on: 6 Oct 2022
This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.
Presented by Andrew Willis (bio)
Pharmaceutical Packaging, Labelling and Artwork Origination
12-13 Dec 2022 - Online webinar
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.
Presented by
George Barrie (bio)
and 6 more leading experts
Practical Implementation of GCP in Veterinary Field Studies
29-30 Nov 2022 - Online webinar
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 with Qualification
20-21 Jun 2022 - London
Also on: 26 Sep 2022
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.
Presented by Bruce Davis (bio)
Quality Management Refresher
29 Sep 2022 - London
Also on: 26 Jan 2023
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.
Presented by Rob Hughes (bio)
Smart Packaging and Electronic Patient Information
13 Jul 2022 - London
Also on: 2 Nov 2022
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.
Presented by Christopher Waterhouse (bio)
Stability Testing of Pharmaceuticals and Biopharmaceuticals
14-15 Jul 2022 - Online webinar
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.
Presented by Paul Palmer (bio)
Sterilization of Medical Devices
20-21 Oct 2022 - Online webinar
Also on: 2 Feb 2023
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.
Presented by Eamonn Hoxey (bio)