US, EU, Japan GMP Requirements (Practical ICH Area Differences, Healthcare Authority Inspection Focus)
Website https://www.demystifiedsolutions.com/trainingDetails/US-EU-Japan-GMP-Requirements-Practical-ICH-Area |
Deadline: April 12, 2017 | Date: April 12, 2017
Updated: 2017-03-09 19:03:10 (GMT+9)
Call For Papers - CFPThis ICH GMP webinar will provide your company the opportunity for comprehensive understand of ICH GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan).Why Should You AttendIt 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 this WebinarUS, 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 BenefitThis 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:- Manufacturing- Quality Assurance- Senior management- Project Managers- Qualified Persons (QPs)- Regulatory Compliance- CMC Personnel- Packaging Experts- Auditors and Staff- ConsultantsFor More Info, Please Click below URL:https://www.demystifiedsolutions.com/trainingDetails/US-EU-Japan-GMP-Requirements-Practical-ICH-Area-Differences-Healthcare-Authority-Inspection-Focus-DEMY051452
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