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This 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.
Pricing Live ( Single registration ) : $189.00 Group ( Max 10 Attendee): $249.00 On Demand (Recording available):$289
I . U.S., EU and Japan GMPs - Status of Harmonization and Where We're Heading Current efforts to further harmonize GMP requirements. Future expectation & likely progress. II . Where Inconsistencies Become a Problem: WHO, ICH, Countries Flexibility in global expectations. Most challenging topics where alignment varies.
III . Key Chapter Reviews ICH GMP organization. Category reviews. IV . Compliance with ICH Guidelines for GMPs Understanding and Insight into Healthcare Authority expectations How GMP requirements / inspections can differ with a single ICH Standard. How regulators (from 3 regions) will assess / enforce compliance with Q7. V . GMP Comparisons for APIs Auditing API facilities. Typical audit agenda. ICH Area differences. VI . GMP Comparisons for Finished Products Auditing finished product facilities. Typical audit agenda. ICH Area differences. VII . GMP Comparisons for Excipients. Sterile products. Biologics. Clinical Packaging. VIII . Differences on Area GMP Inspections Differences on how GMP inspections are conducted. Areas of GMP inspection focus by area. Modifying your self-inspection systems to customized concerns. IX . Outsourcing Management.a Regional Perspective on: Contract manufacturing. Contract packaging. 3 rd Party Contract testing. X . Auditing Your Facilities for Global Considerations Importance of pre-audits to regional GMP focus. How to focus your internal audits to a US, EU and Japan compliance system
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About Speaker
Robert J. Russell is President and CEO of RJR Consulting, Inc, a leading Global Regulatory Consulting firm focusing on assisting the Life Science Industry. Prior to founding the firm in 2000, Mr. Russell had over 27 years of experience in CMC, Global Business Development and Regulatory Compliance for pharmaceuticals, biologics, medical devices and combination products. The company has an office in Brussels, Belgium where they interact with the European Commission and the Competent Authorities across the EU. Country establishment, marketing authorizations, variations and license renewals are core competencies of the course director. Mr. Russell has received a B.S. and M.S.in Chemistry.
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