Course Description
Supplier or vendor qualification is a crucial component in compliance to 21 CFR 111. The FDA requires that manufacturers of dietary supplements must “qualify” each of their vendors but do not provide guidance on how a company is to perform this qualification. Supplier qualification principles also apply to subcontracted services affecting cGMP (manufacturing steps, packaging and labeling, testing and/or calibration services, storage and distribution, etc.) Any supplier qualification program must include two critical components:
- Clearly defined specifications/requirements for all of these goods or services being purchased, and;
- Objective evidence to show that your requirements are being consistently fulfilled.
This eight-hour vendor qualification audit training will help you improve quality in your facility. It is designed for those who already have a basic understanding of dietary supplement GMPs and the knowledge and skills necessary to qualify suppliers.
Since the evaluation of all types of suppliers often involves auditing, this course will incorporate a fresh look at the auditing process and the skills and techniques needed to get the most from these activities. The skills and techniques learned are independent of the type of auditing or the standard being audited and will be useful when conducting internal audits and performing audits of suppliers.
Training Agenda
Agenda – Day 1
Topic 1: The Benefits of Effective Supplier Management
• Key Components of a Supplier Management Program
Topic 2: Regulatory Guidance Review
Understanding Regulatory Requirements and Standards for Supplier and Contract
Manufacturer (CM) Management:
• United States Food and Drug Association (FDA) regulations and guidance
• European Union (EU) directives and guidelines
• International Standardization Association (ISO) standards
• Examples of regulatory findings
Topic 3: The Cost of Poor Quality from Suppliers and CMs:
• How to speak management’s language
Topic 4: Strategic Management of Suppliers:
• Developing a strategic plan based on your company and environment
• Risk Management – A Lifecycle Approach:
➢ Template for a risk assessment
• Topic 5: Supplier qualification: Continued on Day 2
• Selecting a Supplier or Contract Manufacturer
• Obtaining information on suppliers
• Tools for making the selection
– Supplier Assessments:
– Desktop assessments
– Supplier audits
– Handling Supplier Transitions
• How to use your strategic plan to make decisions
• When to use a sole source supplier
Agenda – Day 2
• Topic 5 Supplier qualification:
• Building a Relationships with a Supplier or Contract Manufacturer
• Making your Supplier Quality Agreement a Great Resource:
– Quality Agreement Template
• Monitoring Your Supplier’s Performance to Reduce Risks and Costs:
– Template for a supplier scorecard
• Managing nonconforming events
• Partnering with a Supplier or CM for Improvement:
– Tools for improvement
Why Should You Attend
The various regulatory agencies have expectations that suppliers and vendors will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implemented what they have stated in written procedures and whether their people are doing what the organizations procedures state they will do.
Learning Objectives
On conclusion of this course, you will have an understanding of the following:
- Regulations that apply to vendor qualification (21 CFR 111)
- Food Safety Modernization Act (FSMA)
- Impact of FSMA on supplier qualification
- Risk assessment and risk management
- Supplier monitoring activities
- On-site audit strategies and requirements
- Managing the audit process effectively before, during and after
- The consequences of noncompliance
Who Will Benefit
This intensive, practical course will be of value to those professionals in the pharmaceutical, medical device and related industries who are responsible for or involved in any interaction with suppliers, including those working in:
- Management
- Laboratories
- Auditing
- Purchasing
- QA/QC
- Procurement
- R&D
- Legal
- Manufacturing
- Validation
- Regulatory Affairs
- Documentation Management
Kelly Thomas (25+ year exp.)
Vice President, Americas Quality Operations at Stallergenes Greer - Charlotte Metro USA
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Over 20 years’ experience leading facility start-ups, PAI and Routine cGMP Surveillance inspections. Highly successful global regulatory and ISO compliance history with inspections including FDA, EMEA, IMB, JP, Health Canada, and ANVISA. Highly committed to implementing effective contract manufacturing, supplier management and Internal audit programs.
Strengths include developing staff, maintaining and developing budgets, implementing robust quality systems, communicating and implementing clear Key Performance Metrics (KPIs), conducting Quality Management Reviews and Executive Reports, implementing Lean Six Sigma programs, influencing and implementing positive change, and leading cross-functional teams.
