How to Ensure Your Foreign Vendors are FDA Compliant – Conducting Vendor Audits, Monitoring, and Using Checklists
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This webinar will give information on auditing foreign vendors for FDA compliance. It will discuss initiating audits, planning and preparing vendor audits, as well as, monitoring foreign vendor compliance. This webinar will provide FDA guidance on foreign vendor expectations, what to do and what not to upon selecting a foreign vendor. It will also provide audit formats and checklists for ensuring a foreign vendor is qualified.
Why You Should Attend:
In this webinar attendees will learn how to effectively qualify foreign vendors and suppliers. What are key components necessary in selecting the appropriate foreign vendor, as well as how to create and maintain successful foreign vendor-client relationships through appropriate communication? Attendees will learn how to conduct proper and thorough foreign vendor on-site audits, along with how to correctly and efficiently audit foreign vendors for GMP compliance and create a scoring system for the vendors.
Vendor selection is a serious process. Manufacturers are responsible for compliance from their selected vendors. Any violations from the vendors can cause serious problems for the manufacturers. Choosing a foreign vendor is no different than choosing a domestic vendor. Foreign vendors are held to the same FDA standards as domestic vendors. Manufacturers have to have an assurance that their foreign vendor is suitable. They have to know the vendor will not be the source for major issues as manufacturers are responsible for any vendor oversights or problems.
Areas Covered in the Session :
- Vendor qualification and vendor disqualifications
- Key components necessary in selecting the appropriate vendor
- Successful vendor-client relationships
- Appropriate vendor – client interactions
- Conducting an On-site audit
- Auditing for GMP compliance
- Key documentation requirements
Who Should Attend:
- Regulatory Affairs Departments
- Quality Assurance Departments
- Quality Control Departments
- Compliance Departments
- Vendor Management Personnel
- Auditors
Course Director: JOY MCELROY
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