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Current issues in assuring data integrity in life sciences (WCS)

Tuesday, April 17, 2018, 3:30 PM


Current issues in assuring data integrity in life sciences : 2 Days Seminar *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! ***REGISTER TODAY! 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 (8:30 AM – 4:30 PM) Module 1 Data Integrity Fundamentals •   Data types with examples •   The meaning: raw data, metadata, aberrant data •   The attributes Module 2 Primer on 21 CFR Part 11 •   21 CFR Part 11 and Annex 11 fundamental concepts and differences •   FDA’s current thinking on Part 11 •   Why is Part 11 and Annex 11 not the same as Data Integrity Breakout group exercise: Mapping DI to Part 11 Module 3 Data Integrity Guidance from USFDA/MHRA/EMA/WHO/PCS  •   How do these multiple guidance apply to different situations •   What are the similarities and differences between the guidance Module 4: How to conduct a Data Integrity Risk Assessment •   How is Data Integrity risk assessment different from ICH Q9 risk assessment •   Critical thinking skills for an effective Data Integrity risk assessment •   Factors to be considered when establishing scoring criteria Data Integrity risk assessments •   Mitigation of identified risks to Data integrity and Cyber security   DAY TWO (08:30 AM to 04:30 PM) Module 5: Using the “Least burdensome approach” to implement DI •    What is the “Least Burdensome Approach”  •    Why DI issues occur and how to avoid them proactively •    DI implementation plan: the 5p model and the

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11025 Vista Sorrento Parkway
San Diego, CA 92130

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