This two day course is the ideal external training opportunity for people needing to expand their understanding of Data Integrity requirements through practical exercises and discussion. The knowledge gained will help attendees to implement Data Integrity Initiatives for use in Research and GxP (GLP, GCP, GMP, GDP and GPvP) environments, to assure Research Data Integrity for Funders & Sponsors and compliance with the applicable GxP regulations.
The course starts with an introduction to recent research and regulatory requirements for documents on Data Integrity then expands on the practicalities of assessing Data Integrity Risks and Compliance Controls.
The course provides a mixture of presentations, discussions and practical workshops.
This course will provide delegates with an understanding of Data Integrity including:
Who should attend?
Research Sponsors, Quality, IT and Business professionals who:
Tutors will be comprised from the list below
Trev Simmons
Owner & Principal Consultant, TS CSV QA Ltd (Course Principal)
Lee Monk
Head of Preclinical QA, UCB
Louise Mawer
Director, Mirabilitas Ltd
"Good across GxP oversight and things to consider in context of data integrity assessments."
Please note timings may be subject to alteration
Day 1 |
|
9.00 | Registration |
9.15 | Welcome, introduction and expectation setting |
10.00 | Data Integrity Principles in Practice The fundamentals, why such a "hot topic", real life examples, impacting DI |
11.15 | Break |
11.30 | Data Considerations Understanding data sources, workflows, data interactions, lifecycles |
12.30 | Lunch |
13.15 | Exercise - How to Approach and Plan DI Assessments Where do we start? Points and people to consider - workshop |
14.15 | Feedback |
15.00 | Break |
15.20 | Research and Regulatory Frameworks - Current research and regulatory guidance and expectations - Validation for data integrity Reference to FDA/EMA/MHRA/WHO etc and their similarities and differences etc |
16.20 | Exercise - Finding Your Requirements |
17.30 | Close of day |
Day 2 |
|
9.00 | Recap of Day 1 ALCOA and principles, data life cycle, regulatory expectations |
9.30 | Audit Trail Considerations Points to consider when reviewing audit trails, paper trails, guided example |
10.45 | Break |
11.00 | Workshop (Part 1 - Preparation) - Data Integrity Assessment/Audit - in Practice - Identifying data sources, workflows, data interactions, lifecycle - People and process - Establishing regulatory framework and requirements - Reviewing SOPs, contracts and data sources - Example case studies - GCP/GVP - eCRF/EDC - safety reporting - GMP/GLP - HPLC/LCMS/LIMS - Research - observational studies |
12.45 | Lunch |
13.30 | Workshop (Part 2 - Conduct) - Data Integrity Assessment/Audit - in Practice - Systems, specification and outputs - People and process - Example case studies - GCP/GVP - eCRF/EDC - safety reporting - GMP/GLP - HPLC/LCMS/LIMS - Research - observational studies |
14.30 | Feedback Challenges for conducting a Data Integrity Assessment |
15.15 | Final Case Study Feedback Combined skills learned from Day 1 and Day 2 workshops |
16.00 | CAPA and Data Integrity Incidents |
16.45 | Panel Session |
17.15 | Close of course |
Following requests from attendees of previous RQA events we are pleased to offer course material in PDF format for delegates attending this course.
The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions.
Accommodation is not included in the course fees and can be booked directly with Novotel Heathrow, Cherry Lane, West Drayton.
Where the venue is Madingley Hall, accommodation and dinner are available for the dates of the course (we recommend you take this as the location has few nearby facilities).
If you wish to book additional dates please specify in the ‘accommodation requirements’ box when making your booking and we will check availability with Madingley Hall. Bed and Breakfast is £77*, dinner (three courses with drinks, in the main dining room with other course participants) is £35* (* per night per person) - these can be selected during the booking process. As part of the booking process we ask for dietary requirements and these will be taken in to consideration by Madingley Hall. Alternatively bar snacks are available on a pay as you go basis, not bookable through RQA.