Panel Discussions
- New Regulation Impact on Veterinary Clinical Trial
- GLP/GCLP Question Time
- The GLP committee hosts a panel session packed full of answers and debate. There will be an opportunity to submit questions in advance or live using interactive technology.
Open Disussions
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GLP - Audit Findings and responses
Workshops
- KPI's in QA
- Data Integrity Risk Assessment - as easy as 1,2,3
- Risk Assessments are mentioned 12 times in the OECD DI guidance paper so are a key feature of a facility data integrity governance process. A good risk assessment identifies areas for extra attention but also can justify why some gaps may be okay. But how do we do a risk assessment? this workshop will demonstrate a simple approach to a data integrity risk assessment.
- How Remote Working Has Changed
Presentations
- Impact of Revised OECD Advisory Document on Quality Assurance and GLP
- Identifying the changes and what impact that will have on existing QA Programmes. Risk Assessment seem to be the preferred approach.
- Implementing GCLP Compliance for HIV-1 Vaccine Clinical Trials in Africa
- IAVI conducts Phase I/II HIV-1 vaccine trials in Africa. To ensure clinical trial data integrity, Good Clinical Practice guidelines are implemented through Qualogy limited. The article shows the process.
- Master Schedule: GLP Compliance Requirements and Business Needs
- What is Master Schedule and what does it includes? A common question and point of discussion among GLP professionals. The OECD Principles of GLP define the Master schedule as a compilation of information to assist in the assessment of workload and for the tracking of studies at a test facility. However, it does not provide any specific requirements or information that Master Schedule should include. The US EPA and FDA regulation on GLP specify the requirement of Master Schedule under the QA responsibilities indicating QA should maintain a copy of a master schedule sheet of all nonclinical laboratory studies conducted at the testing facility indexed by test article and containing the test system, nature of study, date study was initiated, status of each study, identity of the sponsor, and name of the study director.
- QA Inter-Site Collaboration to Optimise QA Resources
- This session will explore the reasons for implementing a change to our QA programme, the benefits it will bring and the measures that were put in place to ensure this was implemented successfully.
- Data Integrity Compliance Planning
- A practical example of implementing a programme to review existing Data Integrity controls in a global GLP organisation, and drive improvements to align with the latest regulatory thinking.