Upcoming Events at Mandarin Orchard Singapore
Mon Jul 30, 10:00 AM - Tue Jul 31, 5:00 PM
Mandarin Orchard Singapore
Mandarin Orchard Singapore, Fremont, Si 238867
Community: Times Square
Description
This Seminar will provide information key to managing a successful partnership with Vendors who provide essential services in ensuring that patient safety and data integrity are of an acceptable quality and comply with applicable GCP and GVP regulations.
Event Details
Overview:
This Seminar will provide information key to managing a successful partnership with Vendors who provide essential services in ensuring that patient safety and data integrity are of an acceptable quality and comply with applicable GCP and GVP regulations. Case studies and various scenarios will also be provided with open interactive discussion opportunities encouraged.
Learning Objectives:
• By end of the Seminar attendees should be able to:
• Perform relevant risk assessment to identify and select appropriate (GCP and PV) Vendors
• Assess the requirements that Vendors should satisfy to fulfill their contractual obligations
• Monitor the performance of Vendors
• Understand the role of QA in supporting Vendor management (pre and post qualification activities)
• Analyze information (audit and inspections outcomes) to mitigate potential risks when working with Vendors
Who Will Benefit:
• Staff from the following departments involved in working with Vendors:
• Clinical Operations
• Pharmacovigilance
• QA
• Project Management
• Vendor/Out-Sourcing
Agenda:
Day 1 Schedule
• Background to GCP/GVP regulations
• Identification of Vendors (assessing risk, QA support)
• Selection of Vendors (Pre-assessment process, QA involvement)
• Exercises on Vendor Identification and Selection
Day 2 Schedule
• Managing Vendors (Tools, Data and Compliance Management)
• QA Support, Audits and CAPA Management
• Inspection outcomes (Review and Analysis of GCP and GPV Inspection Findings)
• Case studies and Scenarios – interactive discussions, Exercises
• Q&A forum
Speaker:
Michael Ramcharan
QA professional,QA Consultant
Michael Ramcharan has over 25 years of experience in Quality Assurance having worked with multinational Pharmaceutical and Clinical Research Organisations since 1990. His auditing experience has involved conducting a wide variety of audits in GPVP, GCP and GCLP, globally. He has also hosted and supported various Regulatory Authority Inspections (eg; MHRA, EMA, Local EU) in the GCP and GPV space. Michael’s audit experience has also extended to successfully designing, implementing, and conducting Remote audits in the GPVP arena which has allowed companies to maintain strong over
This Seminar will provide information key to managing a successful partnership with Vendors who provide essential services in ensuring that patient safety and data integrity are of an acceptable quality and comply with applicable GCP and GVP regulations. Case studies and various scenarios will also be provided with open interactive discussion opportunities encouraged.
Learning Objectives:
• By end of the Seminar attendees should be able to:
• Perform relevant risk assessment to identify and select appropriate (GCP and PV) Vendors
• Assess the requirements that Vendors should satisfy to fulfill their contractual obligations
• Monitor the performance of Vendors
• Understand the role of QA in supporting Vendor management (pre and post qualification activities)
• Analyze information (audit and inspections outcomes) to mitigate potential risks when working with Vendors
Who Will Benefit:
• Staff from the following departments involved in working with Vendors:
• Clinical Operations
• Pharmacovigilance
• QA
• Project Management
• Vendor/Out-Sourcing
Agenda:
Day 1 Schedule
• Background to GCP/GVP regulations
• Identification of Vendors (assessing risk, QA support)
• Selection of Vendors (Pre-assessment process, QA involvement)
• Exercises on Vendor Identification and Selection
Day 2 Schedule
• Managing Vendors (Tools, Data and Compliance Management)
• QA Support, Audits and CAPA Management
• Inspection outcomes (Review and Analysis of GCP and GPV Inspection Findings)
• Case studies and Scenarios – interactive discussions, Exercises
• Q&A forum
Speaker:
Michael Ramcharan
QA professional,QA Consultant
Michael Ramcharan has over 25 years of experience in Quality Assurance having worked with multinational Pharmaceutical and Clinical Research Organisations since 1990. His auditing experience has involved conducting a wide variety of audits in GPVP, GCP and GCLP, globally. He has also hosted and supported various Regulatory Authority Inspections (eg; MHRA, EMA, Local EU) in the GCP and GPV space. Michael’s audit experience has also extended to successfully designing, implementing, and conducting Remote audits in the GPVP arena which has allowed companies to maintain strong over
