Current issues in assuring data integrity in life sciences : 2 Days Seminar
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Website https://worldcomplianceseminars.com/seminardetails/11 |
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Deadline: October 01, 2017 | Date: October 04, 2017-October 05, 2017
Venue/Country: Boston,MA Oct 04 - 05,2017, U.S.A
Updated: 2017-08-25 19:34:10 (GMT+9)
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Please Visit :https://worldcomplianceseminars.com/seminardetails/11DescriptionData 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 CoveredWhat is Data integrityData Life Cycle design and controlsElements of a Data Integrity Assurance programRoles and responsibilities of different groups in ensuring data integrityWhat data integrity SOPs do auditors expect to see during auditsValidating Data IntegrityWho will BenefitPharmaceutical industry / Medical device industry / Healthcare industry personnelDevelopers of software for use in Life Sciences industryValidation service providers, IT service providersManufacturing personnel, Manufacturing Automation system vendors and system integratorsRegulatory Affairs group, Quality UnitLaboratory personnelUsers of CloudClinical Trial SponsorsLearning ObjectivesSome advanced Data Integrity topics include:Data Integrity triadData Integrity Maturity ModelDeveloping critical thinking skillsData Integrity Audit trends Course Outline:DAY ONE (08:30 AM to 05:00 PM)Module 1Data Integrity: concepts, requirements, guidance• What is data, raw data, metadata, information and knowledge• Meaning and principles of DI• Data types and their relevance to DI• DI dimensions with examples of 483 and Warning lettersModule 2Primer on CSV and Part 11• What is validation and what is the validation life cycle• GAMP V system categories• What are the validation deliverables and what should they contain• 21 CFR Part 11 Scope and Application guide• Why is Data integrity not the same as 21 CFR Part 11• Latest Part 11 guidance for Clinical investigationsBreakout group exercise: Mapping DI to Part 11Module 3Data Integrity Guidance from USFDA/MHRA/EMA/WHO/PCS• What are similarities and differences between the guidanceModule 4:In the trenches – implementing DI• PQLI and its relevance to Data Integrity• What is the “Least Burdensome Approach” to establishing a DI program• Why DI issues occur and how to avoid them proactively• Top down design and bottoms up implementation• What is the Data Integrity triad• What DI SOPs do auditors want to see and what should their contents beDAY TWO (08:30 AM to 04:30 PM)Module 5:DI in IT and Manufacturing IT systems• Data Integrity impact due to the architecture of IT system• Implementing Active Directory service, Group policy etc. to attain DI• DI susceptibilities of hybrid systems commonly found in manufacturing IT systems • DI risks when generating electronic records which are true copies of paper records• What data integrity items to review for during a Electronic Batch reviewModule 6Data Integrity in the Laboratory• Why is laboratory Data Integrity the key focus of all regulatory audits• Laboratory Data Integrity audit trend and what is needed to avoid citations• Conducting DI risk assessment, trainee participation required• Core documentation that you must have to demonstrate laboratory Data Integrity• What should be the contents of the documents• What is the role of the laboratory manager in fulfilling DIBreakout group exercise: Develop an Audit Trail review SOPModule 7Auditing DI for Internal auditors• Developing a Data Integrity audit checklist• Critical thinking skills for Internal Auditors• How can you effectively use your Data Integrity Maturity Model during audits• FDA’s new approaches to data integrity auditsModule 8DI and CSV Case studies• Case studies presented by trainer• Case studies/experiences by attendees at their workplacePrice/RegisterSeminar One Registration Boston,MA $ 129514-Nov,2017 San Diego CA $ 1295Special Group Discount Register for Four attendees $ 3885Links :https://worldcomplianceseminars.com/seminardetails/11
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