One and a Half Day In-Person Seminar by Former FDA Officer

Building a Vendor Qualification Program for FDA Regulated Industries

BY: Brian G. Nadel,

President, Brian G. Nadel, GMP Consulting, LLC

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This course will provide detailed explanations and examples for Building a Vendor Qualification Program for FDA Regulated Industry. With today’s pharmaceutical market, raw materials, Active Pharmaceutical Ingredients (API), Containers & Closures, inactive or excipients and other components are being sourced from all over the world. We also have Third Party Manufacturers and outside testing facilities that are part of our supply chains. Building and following a robust vendor qualification Program is essential for pharmaceutical and chemical manufacturers. We must create a procedure, which will be used to remain aware of the compliance status for all of our suppliers. Some raw material components may move from producers to brokers to the end users. In addition, there may be other shippers and wholesalers responsible for moving and holding our raw material components.

Since, all of our components are being used to manufacture finished drug products and API, we must ensure the safety, efficacy and purity of these drug products. Our consumers deserve to have a consistent supply of the finished drugs they use each and every day. Many of our raw material ingredients are manufactured globally and we are required by law (21 CFR Part 211.84, Testing and approval or rejection of components, drug product containers, and closures) to be tested and approved before use in manufacturing. Moreover, FDA’s Drug Supply Chain Security Act (DSCSA) requires that we ensure the safety of drug products as they pass through the supply chain and end up in the hands od consumers. Although, Serialization and Traceability are not being discussed during this conference, our vendor qualification and continuous monitoring of our suppliers must be intermingled with our Supplier Quality Audit Programs.

One of the most important objectives during this conference is to write or enhance our Supplier Quality Audit Programs. If you already have a written procedure for conducting supplier quality audits, is this Standard Operating Procedure (SOP) sufficient to comply with all of the Current Good Manufacturing Practice for Finished Pharmaceuticals and ICH Q7 (Good Manufacturing Practice for Active Pharmaceutical Ingredients). We will learn about why we need to regularly audit these suppliers. Also, we must determine a sufficient frequency for conducting audits of all of our suppliers. There are many companies that can conduct Third Party Audits for our companies. Does FDA accept the use of Third Party Audits? Do we need to have two, five, twenty-five, fifty or one hundred Supplier Quality Auditors working at our firms? This depends on the number of suppliers that we have and how often we purchase from these suppliers. Is it acceptable to simply send the suppliers Questionnaires? Are these surveys considered to be an acceptable substitute for direct, physical audits of these suppliers?

We will also learn about estimating the time and travel expenses for these supplier quality audits. We need to have adequate funds to pay for these audits. We will also learn how to write and why we need to prepare audit agendas. What should we do if we do not cover every single item on our audit agendas? The recommended contents of a Supplier Quality Audit Report will also be taught during this presentation.

Learning Objectives:
  • The laws that require supplier quality audits
  • Writing robust procedures for a robust supplier quality audit program
  • Who must conduct these audits
  • What are the qualifications needed for conducting supplier audits
  • How much experience do auditors need
  • Will experienced auditors from another industry suffice for CGMP audits
  • The difficulties of scheduling audits
  • Required number of days for each audit
  • Do we have to cover every single operation during each and every audit
  • Focus on the more important audit objectives first
  • We will learn how to adequately communicate our questions
  • The auditors must ensure that all of our questions are understand and that we understand the answers
  • Do audits need to speak every language in the countries where audits are conducted
  • We will learn how to determine how many auditors we need to conduct each audit
  • Discover the learning potentials during each site visited
Who will Benefit:
  • Quality Assurance and Quality Controls Managers, Supervisors and Directors
  • Supply Chain Personnel
  • Senior Analysts in Chemistry and Microbiology and their Supervisors and Directors
  • Research & Development Directors (for new products and suppliers
Day 01(8:30 AM - 4:30 PM)
  • 8:30 - 9:00 - Registration Process
  • Session Start Time: 9:00 AM
  • Welcome and Introductions (15 Minutes)
  • Understanding the Basics of Quality Systems (45 Minutes)
    • Regulatory References
    • Quality System and Qualification Terminology
  • The Components of a Sustainable Vendor Qualification Program (30 Minutes)
    • 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 (1 Hour)
    • Change Control
    • Complaint Handling
    • CAPAs
    • Deviation Management
    • Sales
  • The Question Phase—What a Potential Vendor Needs to Supply (1 Hour)
    • Vendor Requirements
    • Budget Consideration
    • Documentation of Requirements
    • Understanding and Commitment by Internal Parties
  • Understanding Phase—How Vendors Meet the Requirements (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
  • Evaluation Phase—Determining the Best Potential Vendor (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
  • Site Audit Phase—On-Site and Off-Site Verifications (1 Hour)
    • 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 (30 Minutes)
    • Importance of Continuous Monitoring
    • Requalification Schedule
    • How to Requalify a Vendor
    • Vendor Information File
  • Time and Costs Associated with Vendor Qualification (30 Minutes)
    • Estimating Time Associated with Each Vendor
    • Hidden Costs of Vendor Qualification
    • Estimating Costs of Using Consultants
  • Responding to Audit Findings Associated with Vendor Qualification (30 Minutes)
  • Day 1 Closing Comments and Questions (30 Minutes)
Day 02(8:30 AM - 1:00 PM)
  • 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)
Brian G. Nadel
Brian G. Nadel, President, Brian G. Nadel, GMP Consulting, LLC

Brian G. Nadel is the President/Sole Proprietor of Brian G. Nadel, GMP Consulting, LLC. He has over twenty-five years of diverse experience in: Pharmaceutical Quality Assurance and Quality Systems; FDA Pre-Approval and Inspection Readiness Inspections; International CGMP Auditing for finished drug products, Active Pharmaceutical Ingredients, Fermentation, Process Validation and botanical extraction.

Mr. Nadel utilizes his broad background to assess compliance issues and develop effective, efficient comprehensive systems to ensure CGMP Compliance. He assists pharmaceutical firms in maintaining and developing quality manufacturing operations. He has worked with NDA, ANDA, DMF, BLA and OTC product manufacturers. He has also conducted CGMP training for FDA, Industry and at industry conferences. He has worked to assist clients to comply with the requirements of Consent Decrees. He has used his experience in the pharmaceutical and government regulatory industries to author SOPs in quality and compliance areas.

Mr. Nadel holds a BA in Microbiology and Parasitology from the State University of New York at Albany, NY and is a certified Regulatory Affairs Professional. He is a member of the Parenteral Drug Association and the Regulatory Affairs Professional Society. Mr. Nadel has spoken at many industry conferences, including three conferences in India in 2017.

Mr. Nadel has just completed his third trip to India in 2017. During these visits, he has been working with Indian Pharma to train them to proactively prevent problems and respond to “issues” with the US FDA.

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