Good Practice Training

APHA requires a supplier to deliver a range of Good Practice training via interactive workshops, where participants are active in both discussion and practice of the techniques/skills that are being explored. The inclusion of examples/scenarios are also requested to make learning as ‘real life’ as possible. Our evaluation of training has shown that our learners respond better to this blended approach.

Training courses are to be tailored to animal health and animal scientist research and product needs, with the course content being designed to be relevant to these specific areas of work. All APHA attendees will require a certificate of attendance following the completion of each course. This requirement will need to be in place by December 2026.

The tender will include two distinct, but related Lots concerning GxP Quality Training Courses,

Lot 1 – GLP and GCPv Training Courses

Lot 2 – GMP and GDP Training Courses

Training courses required are:

• Introduction to Good Laboratory Practice (GLP)
• GLP Refresher
• GLP Outline for Test Facility Managers
• GLP Update for Study Directors and Principal Investigators
• GLP Refresher Training – Archivist
• Good Clinical Practice veterinary (GCPv) Refresher
• Introduction to Good Manufacturing Practice (GMP)
• GMP Refresher
• Good Distribution Practice (GDP) Refresher

Lot 1 – GLP and GCPv Training Courses

Service Requirements – GLP Training Courses

Introduction to GLP Training Course

The Introduction to GLP training course needs to include detailed course content on:

• Overview of why GLP is required;
• Roles and responsibilities of Management;
• Roles and responsibilities of the Study Director and the Principal Investigator;
• Roles and responsibilities of study staff;
• Quality Assurance role;
• Training and training records;
• Conditions – testing facility, equipment and materials;
• Study plan (protocol), amendments and deviations;
• Standard Operating Procedures (SOPs);
• Data recording and data integrity;
• Study conduct;
• Final reports;
• Multi-site studies;
• Use of non-GLP compliant facilities;
• Archiving;
• Good Laboratory Practice Monitoring Authority (GLPMA) inspections;
• GLP issues/problems;
• Recent GLPMA inspection findings;
• Hot topics or any new requirements/topics to be introduced.

The learning outcomes of the Introduction to GLP training course are:

• Understand the content of GLP and their specific role(s) in studies.
• Support APHA’s research and commercial studies in line with GLP regulations with an emphasis on reducing duplication of effort and delays in reporting.

GLP Refresher Training Course

The GLP Refresher training course needs to include detailed course content on:

• SOPs;
• Training and training records;
• Data recording and data integrity;
• Study conduct;
• Test item;
• Test systems;
• Facilities and equipment;
• Interactions between different study staff/activities, for example Study Director, ASU, QA and Pathology (APHA to provide the relevant scenario);
• GLPMA inspections;
• GLP issues/problems;
• Recent GLPMA inspection findings;
• Hot topics or any new requirements/topics to be introduced.

The GLP Refresher training course needs to include an overview of:

• GLP and why it is required;
• Roles and Responsibilities;
• Study plan, amendments and deviations;
• Quality Assurance and Inspections.

The learning outcomes of the GLP Refresher training course are:

• Understand the content of GLP and their specific role(s) in studies;
• Support APHA’s research and commercial studies in line with GLP regulations with an emphasis on reducing duplication of effort and delays in reporting.

GLP Outline for Test Facility Managers Training Course

The GLP Outline for Test Facility Managers training course needs to include detailed course content on:

• Roles and responsibilities of staff;
• Test Facility Management (TFM) responsibilities;
• TFM interaction with QA;
• Ensuring data integrity;
• Potential risks to GLP compliance;
• Resolving potential GLP problems;
• Multi-site studies; use on non-GLP compliant facilities;
• Update on best practice;
• Recent GLPMA inspection findings.

The learning outcomes of the GLP Outline for Test Facility Managers training course are:

• Understand the content of GLP and their specific role(s) in studies;
• Support APHA’s research and commercial studies in line with GLP regulations with an emphasis on reducing duplication of effort and delays in reporting.

GLP Update for Study Directors and Principal Investigators Training Course

The GLP Update for Study Directors and Principal Investigators training course needs to include detailed course content on:

• Why GLP is required;
• Roles and responsibilities of Management;
• Roles and responsibilities of the Study Director and the Principal Investigator;
• Roles and responsibilities of study staff;
• Multi-site studies;
• Role of Quality Assurance;
• Selection of test sites;
• Use on non-GLP compliant facilities/sites;
• Study plans, amendments and deviations;
• Problem solving and prevention;
• Study conduct - managing compliance issues;
• Data recording - specimen management;
• Final report content - report amendments;
• Compliance statements – potential issues;
• Electronic data;
• Computer system validation;
• Data integrity;
• Archiving;
• GLPMA inspections;
• GLP issues/problems;
• Recent GLPMA inspection findings;
• Update on best practice;
• Characterisation of test items.

The learning outcomes of the GLP Update for Study Directors and Principal Investigators training course are:

• Understand the content of GLP and their specific role(s) in studies;
• Support APHA’s research and commercial studies in line with GLP regulations with an emphasis on reducing duplication of effort and delays in reporting.

GLP Refresher Training – Archivist Training Course

The GLP Refresher Training – Archivist training course needs to include detailed course content on:

• Roles and responsibilities of staff;
• GLP requirements for archiving;
• Design of an Archive;
• Archiving of electronic data;
• Records management and data integrity;
• Archiving of specimens;
• Potential GLP issues;
• Audits and regulatory inspections of the archive;
• Update on best practice;
• Recent GLPMA inspection findings.

The learning outcomes of the GLP Refresher Training – Archivist training course are:

• Understand the content of GLP and their specific role(s) in studies;
• Understand what constitutes an Archive;
• Understand specific regulatory requirements which apply to such facilities and ensure compliance with them.

Service Requirements - GCPv Training Courses

GCPv Refresher Training Course

The GCPv Refresher training course needs to include detailed course content on:

• Understanding the rationale for Veterinary Good Clinical Practice (VICH GCP) and the documents and guidelines available;
• Roles and responsibilities of Investigator, Sponsor and Monitor;
• Quality Assurance;
• Study design and study conduct;
• SOPs;

•Staff training;

•Facilities and equipment;

•Documentation – protocol, amendments, deviations, lab reports, final study report, archiving;

•Adverse events;

• Control of the IVP and specimens, including maintaining the blind/masking;

•Data recording and corrections;

• Interaction between the Investigator and the Monitor;
• Common issues.

The learning outcomes of the GCPv Refresher training course are:

• Understand the content of GCPv;
• Explain what the responsibilities of their specific role are and undertake them in line with GCPv requirements;
• Have a clear understanding of the EU and UK requirements.