Description
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.
Agenda: (All time in EST):
• 1:00-2:15 pm (Course Delivery)
• 2:15-2:30 pm (Q&A Session)
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
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.
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.
Agenda: (All time in EST):
• 1:00-2:15 pm (Course Delivery)
• 2:15-2:30 pm (Q&A Session)
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
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.
