CAPA Simplified - A one-form, easy-to-complete, method for simplifying your CAPA process
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Website https://www.traininng.com/webinar/-200729live?channel=ourglocal-march_2019_SEO |
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Category online training courses for hr professionals,online training programs for hr professionals, HR Training and Development
Deadline: March 25, 2019 | Date: March 25, 2019
Venue/Country: Online Event, U.S.A
Updated: 2019-02-28 16:10:15 (GMT+9)
Call For Papers - CFP
OverviewThis presentation will cover the FDA regulations (21 CFR Subpart J) regarding CAPA, how CAPA should be integrated into other branches of your Quality Management System, how to best approach CAPA (including initiation, evaluation, and follow-up verification), examples of documentation you can use to fulfill the CAPA requirement, as well as tips and tricks to what FDA auditors will look for when they come to visit your site.We will also go over some additional tips and tricks on how to convey the importance of CAPA within your organization and ensure resources are provided to meet CAPA process needs. At the end of the presentation, I will answer any questions or concerns you may have regarding the CAPA process.Why should you AttendGet an in-depth understanding of regulatory agencies such as the FDA requiring for CAPAEvaluate your already-existing CAPA process to determine if it meets requirementsDetermine if your CAPA system is robust enough to ensure actions are effective or overly-complicated and preventing smooth operationOverview of commonly-used root cause analysis functionsUnderstand some misconceptions with CAPA implementationTips and tricks for implementing a successful CAPA systemAreas Covered in the SessionRegulatory requirements for CAPAResponsibilities of manufacturersBest practices for CAPA implementationFDA expectationsDocumentation requirementsWho Will BenefitQuality Control Personnel & ManagementManufacturing Personnel & ManagementSenior ManagementRegulatory Affairs Personnel & ManagementQuality Assurance Personnel & ManagementSupplier Quality Personnel & ManagementDevelopment EngineersProduction ManagementQA/QC PersonnelSoftware DevelopersUsability engineersRisk managersDesign Engineering ManagersMedical Device EngineeringQuality AssuranceRegulatoryManagementSpeaker ProfileDenise Wrestler ASQ CQE, CQA; QA/RA Consultant at CYA Medical Device Consulting, LLC with almost 15 years of experience within FDA-regulated industries including medical device and pharmaceuticals, Ms. Wrestler provides quality, regulatory, and technical expertise to meet individual client needs. Ms. Wrestler agrees with the FDA's "least burdensome approach" and prides herself on providing options and recommendations for ensuring regulations are met without wasting precious company resources. Event link: https://www.traininng.com/webinar/-200729live?channel=ourglocal-march_2019_SEOContact InfoTraininng.com LLC Email: traininngdotcomgmail.com Phone: US: (510) 962-8903Phone: Zurich: +41 - 43 434 80 33Website : https://www.traininng.com
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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