Vendor selection is a serious process. Manufacturers are responsible for compliance with 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 of major issues. Manufacturers are responsible for any vendor oversights or problems. In this seminar participants will understand how to make sure their foreign and domestic vendors are compliant and stay in compliance.
Why You Should Attend:
Participants in this 2 day workshop will learn what qualifies a foreign vendor and what disqualifies a foreign vendor for providing services and goods to your facility. They will learn how to initiate audits from foreign vendors and suppliers. Participants will learn how to relate to foreign vendors, and how to speak in common terms that are familiar to the foreign vendor and/or supplier as well as the manufacturer. Participants will gain an understanding of how to conduct on-site audits for foreign vendors. They will have an understanding of how to rate foreign vendors and maintain successful foreign -client relationships.
Learning Objectives:
Vedor qualification and vendor disqualifications
Initiating audits
Planning for audits
Preparing audit schedules
Conducting on-site vendor audits
Rating foreign vendors for compliance
Maintaining successful foreign vendor-client relationships
Requalifying foreign vendors and performing follow-up audits
Key audit documentation requirements
Areas Covered:
Selection and Qualification documentation
Key components necessary in selecting the appropriate vendor
Successful vendor-client relationships
Appropriate vendor-client interactions
Auditing for GMP compliance
Audit Checklists
Audit / Qualification rating scale
Document Review
Who Should Attend:
Regulatory Affairs Management and Staff
Quality Assurance Management and Staff
Documentation Management and Staff
Compliance Management and Staff
Auditors
Suppliers and Vendors Management Teams