Building a Vendor Qualification Program for FDA Regulated Industries
Jonathan M. Lewis, Founding Partner, Reliant FDA Experts™…a Division of Advanced Biomedical Consulting, LLC
Coming soon.. Please contact customer care for new schedule
||Course "Building a Vendor Qualification Program for FDA Regulated Industries" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
If you are looking for the answer to the following questions, you will certainly benefit from attending this seminar on building a vendor qualification program:
- Have you wasted hours, days, and weeks on qualifying vendors that you know cannot or will not meet your requirements?
- Has your approach to vendor qualification and vendor audits left you with internal CAPAs, customer audit items, or 483 observations?
- Have you wondered whether an onsite vendor audit is necessary in the eyes of FDA?
Well, the answers to these and many more questions are now available in a simple to understand, yet detailed training session designed to help manufacturers of FDA regulated products build (or rebuild) a sustainable vendor qualification program.
This course on vendor qualification program for FDA regulated industries will:
- Define a sustainable structure for a vendor qualification program.
- Explain how change control and other quality programs feed into the vendor qualification program.
- Offer usable audit forms/checklists and other vendor qualification program document templates.
- Explain how to:
- Determine the best potential vendor and what a potential vendor needs to supply before qualification.
- Initially identify vendors that meet your requirements prior to qualification.
- Perform on-site and off-site verifications.
- Monitor and re-qualify vendors.
- Estimate costs and time associated with vendor qualification.
- Respond to customer and regulatory audit observations associated with vendor qualification.
- Discuss common pitfalls to avoid when qualifying vendors.
Seminar Fee Includes:
USB with seminar presentation
Hard copy of presentation
$100 Gift Cert for next seminar
Who Will Benefit:
This course will provide valuable assistance and guidance to all FDA regulated companies for building sustainable vendor qualification program. The following job titles/ positions will benefit from attending this seminar:
- Internal Auditors
- Legal Departments
- Compliance Officers
- Purchasing Managers
- QC Managers
- QA Managers
- Quality and Sales Department Staff
- Compliance Consultants
- Senior Management
|DAY ONE (8:30 AM – 4:30 PM)
||DAY TWO (8:30 AM – 1:00 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
Welcome and Introductions (15 Minutes)
- Understanding the Basics of Quality Systems (45 Minutes)
The Components of a Sustainable Vendor Qualification Program (30 Minutes)
- Regulatory References
- Quality System and Qualification Terminology
Other Programs that Feed the Vendor Qualification Program (1 Hour)
- Vendor Requirements
- Vendor Type Classifications
- Audit Forms/Checklists
- Vendor Information Files
- Approved Vendor List
- Requalification Schedule
- Standard Operating Procedures (SOPs)
The Question Phase—What a Potential Vendor Needs to Supply (1 Hour)
- Change Control
- Complaint Handling
- Deviation Management
Understanding Phase—How Vendors Meet the Requirements (1 Hour)
- Vendor Requirements
- Budget Consideration
- Documentation of Requirements
- Understanding and Commitment by Internal Parties
Evaluation Phase—Determining the Best Potential Vendor (1 Hour)
- 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
Site Audit Phase—On-Site and Off-Site Verifications (1 Hour)
- Requirements for Entering the Evaluation Phase
- Purpose of the Evaluation
- Format of the Evaluation
- Using Rating Systems
- End Result of the Evaluation Phase
Track Phase—Monitor and Requalify (30 Minutes)
- 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
Time and Costs Associated with Vendor Qualification (30 Minutes)
- Importance of Continuous Monitoring
- Requalification Schedule
- How to Requalify a Vendor
- Vendor Information File
Responding to Audit Findings Associated with Vendor Qualification (30 Minutes)
Day 1 Closing Comments and Questions (30 Minutes)
- Estimating Time Associated with Each Vendor
- Hidden Costs of Vendor Qualification
- Estimating Costs of Using Consultants
Welcome and Day 1 Reinforcement (15 Minutes)
- Site Audit Phase—On-Site and Off-Site Verifications (1 Hour)
- Practical Application # 1 –Qualifying a Services Vendor (1 Hour)
- Practical Application # 2 –Qualifying a Raw Material Vendor (1 Hour)
- Practical Application # 3 –Vendor Qualification 483 Response (1 Hour)
- Closing Comments (15 Minutes)
- Individual/Open Q&A Session (30 Minutes)
Meet Your Instructor
||Jonathan M. Lewis
Founding Partner, Reliant FDA Experts™…a Division of Advanced Biomedical Consulting, LLC
Jonathan M. Lewis, founding partner, Reliant FDA Experts™ - a division of Advanced Biomedical Consulting, LLC, has over nineteen years’ experience in the areas of quality control/quality assurance (QA/QC), regulatory affairs, manufacturing, validation, project management, and executive management in both the industry and in consulting roles. Mr. Lewis has experience in the medical device, diagnostic, biopharmaceutical, pharmaceutical, cosmetic, nutritional supplement, food, and animal food industries.
Prior to founding Reliant FDA Experts™, Mr. Lewis worked for KMI/PAREXEL, a regulatory compliance and validation consulting firm, in increasing roles of responsibility from an entry-level validation engineer to the associate director of consulting. He has worked at RPScherer (Cardinal Health), a contract and proprietary solid oral dose pharmaceutical manufacturing facility, as the QC/validation manager. In addition, he has worked at Telectronics Pacing Systems, a medical device manufacturer, as a sterility assurance laboratory technician.
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