US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus
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Website https://compliance2go.com/product/?pid=CP2014-382 |
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Category Biotechnology , Medical Device , Pharmaceutical
Deadline: November 10, 2014 | Date: November 10, 2014
Venue/Country: Houston, U.S.A
Updated: 2014-10-28 18:39:49 (GMT+9)
Call For Papers - CFP
DESCRIPTIONThis 90 minute webinar will help you gain a detailed overview of ICH GMPs and the nuances and differences between requirements in the US, EU and Japan. It will help prepare you for regulatory inspections in these countries.Why Should You Attend?This ICH GMP training course will provide your company the opportunity for a detailed overview of ICH GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan).It will cover the key areas of how ICH was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA.Areas Covered in the Seminar :US, EU, Japan GMP Requirements(Practical ICH Area Differences, Healthcare Authority Inspection Focus)I . U.S., EU and Japan GMPs - Status of Harmonization and Where We're HeadingCurrent efforts to further harmonize GMP requirementsFuture expectation & likely progressII . Where Inconsistencies Become a Problem: WHO, ICH, CountriesFlexibility in global expectationsMost challenging topics where alignment variesIII . Key Chapter ReviewsICH GMP organizationCategory reviewsIV . Compliance with ICH Guidelines for GMPsUnderstanding and Insight into Healthcare Authority expectationsHow GMP requirements / inspections can differ with a single ICH StandardHow regulators (from 3 regions) will assess / enforce compliance with Q7V . GMP Comparisons for APIsAuditing API facilitiesTypical audit agendaICH Area differencesVI . GMP Comparisons for Finished ProductsAuditing finished product facilitiesTypical audit agendaICH Area differencesVII . GMP Comparisons for :ExcipientsSterile productsBiologicsClinical PackagingVIII . Differences on Area GMP InspectionsDifferences on how GMP inspections are conductedAreas of GMP inspection focus by areaModifying your self-inspection systems to customized area concernsIX . Outsourcing Management. A Regional Perspective on:Contract manufacturingContract packaging.3 rd Party Contract testingX . Auditing Your Facilities for Global ConsiderationsImportance of pre-audits to regional GMP focus.How to focus your internal audits to a US, EU and Japan compliance system.Who Will Benefit:This Webinar will provide valuable assistance to all License Owner personnel in the Pharmaceutical, Biotechnology and Combination Products areas, including contract manufacturers, packagers and suppliers. Particular functional expertise receiving value from attending would be:ManufacturingQuality AssuranceSenior managementProject ManagersQualified Persons (QPs)Regulatory ComplianceCMC PersonnelPackaging ExpertsAuditors and StaffConsultantsWebinar Includes:Q/A Session with the Expert to ask your questionHandouts (PDF print only copy of PowerPoint slides)90 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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