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Vendor Qualification in Pharma Industry
- 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
Overview of the webinar
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. Learning Objectives are:
- 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
Who should attend?
- 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
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
Faculty - Ms.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 Drug Product manufacturing from the CMC side. From the Regulatory affairs perspective, she provides regulatory leadership and expertise for regulatory strategy, liaises with the regulatory agencies including FDA, Health Canada and other Health authorities. For her leadership approach, she brings a strong focus beyond the necessary technical disciplines and regulations, looking at the interplay of culture and teamwork for successfully advancing programs in an effective and efficient manner. Gowri holds a master’s Degree in Biosciences as well as the prestigious Regulatory Affairs Certification (RAC) awarded by the Regulatory Affairs Professional Society. She is the author or co-author of several peer-reviewed research publications as well as book chapters. Gowri has breath of experience spanning R&D, CMC and Regulatory affairs. She also serves as a reviewer for several international Bioscience Journals for providing Scientific and technical expertise.