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Current issues in assuring data integrity in life sciences : 2 Days Seminar (wcs)

Thursday, April 5, 2018, 8:30 AM


Current issues in assuring data integrity in life sciences : 2 Days Seminar Data Integrity is a major concern of regulatory agencies worldwide as evidenced by the increasing number of Warning Letters issued in that area.  Some managements have proceeded to implement data integrity programs on the lines of those implemented in “big data”.  This has resulted in the escalation of costs and it is disproportionate to the benefits gained.  Some even wonder why they continue to receive Warning Letters in spite of spending the dollars to implement programs such as Data Governance etc. etc. This training focuses on implementing Data Integrity programs using “the least burdensome” approach, a technique that regulators themselves employ to conduct their audits. The training also addresses the evolving concepts and guidance from regulatory agencies such as the recently issued industry guidance on Part 11 for Clinical Investigations among many others. Addressed will be case studies, inspection approaches, and trends in the issuance of data integrity 483s and warning letters in the recent past. Take back to your work, samples of Data Integrity related directives and SOPs such as Data Integrity Policy, Maintenance of Electronic Records directive and many more that are required to establish a data integrity infrastructure in your company. This workshop is for novices as well as experienced personnel from QA, IT, manufacturing, regulatory and validation groups. It addresses data integrity issues in all life science industry sectors where data is required to fulfill regulatory requirements.  These sectors include medical devices, biologics manufacturing, quality control laboratories, clinical trials, blood establishments, compounding pharmacies etc.  Areas Covered What is Data integrity Data Life Cycle design and controls Elements of a Data Integrity Assurance program Roles and responsibilities of different groups in ensuring data integrity What data integrity SOPs do auditors expect to see during audits Validating Data Integrity   Who will Benefit Pharmaceutical industry / Medical device industry / Healthcare industry personnel Developers of software for use in Life Sciences industry Validation service providers, IT service providers Manufacturing personnel, Manufacturing Automation system vendors and system integrators Regulatory Affairs group, Quality Unit Laboratory personnel Users of Cloud Clinical Trial Sponsors   Learning Objectives Some advanced Data Integrity topics include:          Data Integrity triad          Data Integrity Maturity Model          Developing critical thinking skills          Data Integrity Audit trends  Course Outline: DAY ONE (08:30 AM to 05:00 PM) Module 1 Data and Data Integrity: concepts, meaning of integrity, data dimensions    • Practically speaking, what is data, raw data, metadata    • Meaning and principles of DI    • Data types and their relevance to DI    • DI dimensions with examples of 483 and Warning letters    • Why is DI not considered to be a new requirement   Module 2 Primer on 21 CFR Part 11    • 21 CFR Part 11 (P11) and Annex 11 (A11) fundamental concepts    • P11 Scope and Application guide    • Why is Data integrity not the same as x11 (P11 and A11)   Breakout group exercise: Mapping DI to Part 11   Module 3 Data Integrity Guidance from USFDA/MHRA/EMA/WHO/PCS     • What are similarities and differences between the guidance   Module 4:  "Implementing a DI assurance plan using the “Least burdensome approac”    • PQLI and its relevance to Data Integrity    • What is the “Least Burdensome Approach”    • Why DI issues occur and how to avoid them proactively    • DI implementation plan: the 5p model and the Controls Triad    • What DI SOPs do auditors want to see and what should their contents be   DAY TWO (08:30 AM to 04:30 PM) Module 5: Data Integrity in IT and Manufacturing IT systems     • Data Integrity impact due to the architecture of IT system     • Implementing Active Directory service,

Tickets: https://www.eventbrite.com/e/current-issues-in-assuring-data-integrity-in-life-sciences-2-days-seminar-wcs-tickets-42044172251?aff=aff0eventful

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11025 Vista Sorrento Parkway
San Diego, CA 92130

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