Sustainable Vendor Qualification in Pharma Industry
Duration : 60 Minutes
Gowri Sukumar,
Gowri Sukumar is the Director, CMC and Regulatory Affairs for Iterion Therapeutics, Houston, TX. Unique to her experience is leading all the technical disciplines of CMC development as well as regulatory Affairs. She has broad responsibilities that include process development, Drug Substance and D Read more
This webinar will provide insights on building sustainable vendor qualification program specific to the FDA regulated industries. Will shed light on the importance of Vendor qualification and on each and every step involved in the process and the risk assessment. Will cover other related aspects including the Auditing process, Performance monitoring and the communication process.
Course Objectives:
• Importance of vendor qualification
• Understanding the vendor qualification program
• Step by step process in the vendor qualification
• Application of Risk assessment
• Audit forms/ checklists and other vendor qualification program documents
• Keys to determine the best potential vendor
• Overview of the auditing process
• Keys to performance monitoring
• Efficient communication processes
Why Should You Attend:
It is important for the sponsor(s)/ Pharma companies and their compliance personal to understand the process/ steps to the vendor qualification process for FDA regulated companies/ their products. Also, understanding the vendor qualification options, application of risk assessment, the auditing process as well as performance monitoring. This understanding can help identify common pitfalls to avoid when qualifying vendors.
Course Outline:
• Importance of vendor qualification
• Understanding the vendor qualification program
• Step by step process in the vendor qualification
• Application of Risk assessment
• Audit forms/ checklists and other vendor qualification program documents
• Keys to determine the best potential vendor
• Overview of the auditing process
• Keys to performance monitoring
• Efficient communication processes
What You Get:
• Training Reference Materials
• Live Q&A with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
The following professionals or disciplines will benefit from attending this Webinar:
• Internal Auditors
• Compliance officers
• Purchasing Managers
• Quality control Managers
• Quality Assurance Managers
• Senior management
• Regulatory affairs professionals
• Senior management executives (CEO, COO, CFO, etc.)
• Regulatory Compliance Associates and Managers
• People investing in FDA-regulated product development projects
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
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