Data Integrity in Practice

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Course Information

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:

Data Integrity Principles in Practice
Data Considerations (Sources, Workflows & Interactions, Lifecycles)
Practical Approach Data Integrity assessments (including audit)
Current Research and Regulatory Guidance and expectations
CAPA & Data Integrity Incidents Case Studies

Who should attend?

Research Sponsors, Quality, IT and Business professionals who:

Want to gain experience assessing and implementing solutions to manage Data Integrity risks
Monitor or audit systems and facilities for Data Integrity
System owners, end users, testers and project staff involved the Management of Data

Course Tutors

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

Course Programme

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

Course Material

Following requests from attendees of previous RQA events we are pleased to offer course material in PDF format for delegates attending this course.

The advantages of this include

Ability for delegates to keep material on a mobile device
Ability to review material at any time pre and post course
Environmental benefits – less paper being used per 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

Accommodation is not included in the course fees and can be booked directly with Novotel Heathrow, Cherry Lane, West Drayton

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