This 90 minute webinar will help you gain a detailed overview of ICH GMPs and th
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| Description: | Industry: Biotechnology , Medical Device , Pharmaceutical Speaker: Robert J. Russell Wednesday May-4-2016 01:00 PM | 02:30 PM - EDT DESCRIPTION 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. 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 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 area 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. 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: Manufacturing Quality Assurance Senior management Project Managers Qualified Persons (QPs) Regulatory Compliance CMC Personnel Packaging Experts Auditors and Staff Consultants Webinar Includes: Q/A Session with the Expert to ask your question Handouts (PDF print only copy of PowerPoint slides) 90 Minutes Live Presentation Certificate of Attendance |
| URL: | https://www.compliance2go.com/product/?topic=gmp-requirements |
| Date: | Wednesday, May 4, 2016 |
| Access: | Public |
| Category: | Education* |
| Created by: | Public Access |
| Updated: | Monday, April 25, 2016 9:05am UTC |
| : | $179 |
| : | (877) 782-4696 |
| : | subscribe@compliance2go.com |
| : | David |
| : | (877) 782-4696 |
| Comments: | None |