Building a Vendor Qualification Program for FDA Regulated Industries

4 years ago Posted By : User Ref No: WURUR88749 0
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  • TypeSeminar
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  • Location Online Event
  • Price
  • Date 17-11-2021 - 18-11-2021
Seminar Title
Building a Vendor Qualification Program for FDA Regulated Industries
Event Type
Seminar
Seminar Date
17-11-2021 to 18-11-2021
Location
Online Event
Organization Name / Organize By
complianceonline
Organizing/Related Departments
Sales & marketing
Organization Type
Event Management Company
SeminarCategory
Both (Technical & Non Technical)
SeminarLevel
All (State/Province/Region, National & International)
Related Industries

Administration/Management

Manufacturing

Medical/Healthcare/Hospital

Location
Online Event

DAY 01(10:00 AM - 5:00 PM EST)

  • Session Start Time: 10:00 AM
  • Welcome and Introductions
  • Understanding the Basics of Quality Systems
    • Regulatory References
    • Quality System and Qualification Terminology
  • The Components of a Sustainable Vendor Qualification Program
    • Vendor Requirements
    • Vendor Type Classifications
    • Audit Forms/Checklists
    • Vendor Information Files
    • Approved Vendor List
    • Requalification Schedule
    • Standard Operating Procedures (SOPs)
  • Other Programs that Feed the Vendor Qualification Program
    • Change Control
    • Complaint Handling
    • CAPAs
    • Deviation Management
    • Sales
  • The Question Phase—What a Potential Vendor Needs to Supply
    • Vendor Requirements
    • Budget Consideration
    • Documentation of Requirements
    • Understanding and Commitment by Internal Parties
  • Understanding Phase—How Vendors Meet the Requirements
    • Initial Contact with Potential Vendors
    • How to Supply Vendor with Company Requirements
    • Contents of a Vendor Package
    • Obtaining Multiple Vendor Packages
    • How to Assess Packages for Adequacy and Completeness
  • Evaluation Phase—Determining the Best Potential Vendor
    • Requirements for Entering the Evaluation Phase
    • Purpose of the Evaluation
    • Format of the Evaluation
    • Using Rating Systems
    • End Result of the Evaluation Phase
  • Site Audit Phase—On-Site and Off-Site Verifications
    • Classification of Vendors
    • On-Site vs. Off-Site Audits
    • On-Site Verification Form
    • Off-Site Audit Checklist
    • How to Score the Audit
    • Options for Rejected Vendors
  • Track Phase—Monitor and Requalify
    • Importance of Continuous Monitoring
    • Requalification Schedule
    • How to Requalify a Vendor
    • Vendor Information File
  • Time and Costs Associated with Vendor Qualification
    • Estimating Time Associated with Each Vendor
    • Hidden Costs of Vendor Qualification
    • Estimating Costs of Using Consultants
  • Responding to Audit Findings Associated with Vendor Qualification
  • Day 1 Closing Comments and Questions

DAY 02(10:00 AM - 5:00 PM EST)

  • Site Audit Phase—On-Site and Off-Site Verifications
  • Practical Application # 1 –Qualifying a Services Vendor
  • Practical Application # 2 –Qualifying a Raw Material Vendor
  • Practical Application # 3 –Vendor Qualification 483 Response
  • Closing Comments
  • Individual/Open Q&A Session
Registration Fees
Not Mention
Registration Ways
Email
Website
Address/Venue
Virtual Seminar  Virtual Seminar,6201 America Center Drive Suite 240, San Jose, CA 95002, USA 
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