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
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
Address/Venue
Virtual Seminar
Virtual Seminar,6201 America Center Drive Suite 240, San Jose, CA 95002, USA