FDA's New Enforcement of 21 CFR Part 11- by Dr Ludwig Huber
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Website https://compliance2go.com/product/?topic=fdas-new-enforcement-of-21-cfr-part-11-dr-ludwig-huber |
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Category Medical Device , Pharmaceutical
Deadline: May 27, 2015 | Date: May 27, 2015
Venue/Country: Houston, U.S.A
Updated: 2015-05-08 20:36:58 (GMT+9)
Call For Papers - CFP
DESCRIPTIONFDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings. The seminar will have the answers. And using industry proven case studies on how to avoid 483 inspectional observations and warning letters attendees will learn how to prepare their organization for trouble-free Part 11 related inspections.Topics:FDA’s current inspection and enforcement practicesFDA’s new interpretation: learning from FDA inspection reportsStrategy for cost-effective implementation of Part 11: A six step planRecommended changes to existing Part 11 programs to reduce costsJustification and documentation for the FDA and your managementGoing through case studies from laboratories, offices and manufacturing with graphical workflow of records, step-by-step description, recommendations for individual Part 11 requirements with justifications and documentation for the FDA and your management.Case studies how to avoid or respond to Part 11 related observations with corrective actions to fix current issues and preventive actions to prevent reoccurrence of the same or similar issues.How to prepare your company for Part 11 InspectionsWho will benefit :IT managers and system administratorsQA managers and personnelAnalysts and lab managersValidation groupsSoftware developersValidation professionalsTraining departmentsDocumentation departmentConsultantsWebinar Includes:Q/A Session with the Expert to ask your questionPDF print only copy of PowerPoint slides75 Minutes Live PresentationCertificate of Attendance
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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