Good Practice Training

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.

Service Requirements – GMP Training Courses Introduction to GMP Training Course The Introduction to GMP training course needs to include detailed course content on: • Requirements and principles of GMP; • Roles and responsibilities; • Overview of EU and UK requirements; • Hot topics from MHRA/Veterinary Medicines Directorate (VMD); • Compliance; • Change control; • Validation of equipment/computer systems. Please Note: course content will be required to cover requested topics based on APHA specific needs, this includes but is not limited to a Quality Control (QC) Contract Laboratory. Some background and risk management content with an emphasis on QC will be required. The learning outcomes of the Introduction to GMP training course are: • Understand the content of GMP; • Explain what the responsibilities of their specific role(s) are and undertake them in line with GMP requirements; • Have a clear understanding of the EU and UK requirements. GMP Refresher Training Course The GMP Refresher training course needs to include detailed course content on: • Overview of GMP requirements; • Overview of roles and responsibilities; • Overview of EU and UK requirements; • Explore consequences of mistakes and bad habits; • Hot topics from MHRA/VMD; • Compliance; • Change control; • Validation of equipment/computer systems. Please Note: course content will be required to cover requested topics based on APHA specific needs, this includes but is not limited to a Quality Control (QC) Contract Laboratory. Some background and risk management content with an emphasis on QC will be required. The learning outcomes of the GMP Refresher training course are: • Understand the content of GMP; • Explain what the responsibilities of their specific role(s) are and undertake them in line with GMP requirements; • Have a clear understanding of the EU and UK requirements; • Identify and implement possible improvements to current processes. Service Requirements – GDP Training Courses GDP Refresher Training Course The GDP Refresher training course needs to include detailed course content on: • Requirements and principles of GDP; • Overview of EU and UK requirements; • Roles and responsibilities; • Compliance. Please Note: course content is to take into consideration that APHA conforms to GDP in relation to veterinary use as opposed to ‘human use’. The learning outcomes of the GDP Refresher training course are: • Understand the content of GDP; • Explain what the responsibilities of their specific role(s) are and undertake them in line with GDP requirements; • Have a clear understanding of the EU and UK requirements.