Qualifying Foreign Vendors; Making Sure Your Foreign Vendor is FDA Compliant and Stays That Way

Location: Raleigh-Durham, NC, USA       Duration: 2 days

Date: October 18 - 19, 2018 from 830AM-430PM edt

Presenter: Joy McElroy

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 assurance that their foreign vendor is suitable. They have to know the vendor will not be the source for major issues. Manufacturers are responsible for any vendor oversights or problems. In this webinar participants will understand how to make sure their foreign and domestic vendors are compliant and stay in compliance.

Areas Covered:

  • Vendor qualification and vendor disqualifications

  • Qualification documentation

  • 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

  • Audit/ Qualification Rating Scale

  • Key Audit documentation requirement

Key Learning Objectives:

  • Vendor qualification and vendor disqualifications

  • Initiating Audits

  • Planning for Audits

  • Preparing Audit Schedules

  • Conducting on-site Vendor Audits

  • Rating Foreign Vendors for Complaince

  • Maintaining successful foreign Vendor-Client relationships

  • Requalifying Foreign Vendors and performing follow-up Audits

  • Key documentation Requirements

Who Will Benefit:

  • Regulatory affairs personnel

  • Quality assurance personnel

  • Managers and Supervisors

  • People interested  in the FDA-regulated industries

  • Auditors

Seminar Fee Includes:

Training

Lunch

AM-PM Tea/Coffee

Seminar Materials

USB with Presentation Handouts

Attendee Certificate

Networking Session

$100 Gift Voucher for next Seminar

 

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