Supplier or vendor qualification is a crucial component in compliance to 21 CFR 111. The FDA requires that manufacturers of dietary supplements, Pharmaceuticals, Biotech and Medical Device 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.
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.
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.
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.
Course Content
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
- 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
- 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
Agenda
Topic 1: The Benefits of Effective Supplier Management- Key Components of a Supplier Management Program
- Understanding Regulatory Requirements and Standards for Supplier and Contract
- 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
- How to speak management’s language
- Developing a strategic plan based on your company and environment
- Template for a risk assessment
- Selecting a Supplier or Contract Manufacturer
- Obtaining information on suppliers
- Tools for making the selection
- Desktop assessments
- Supplier audits
- Handling Supplier Transitions
- How to use your strategic plan to make decisions
- When to use a sole source supplier
- Building a Relationships with a Supplier or Contract Manufacturer
- Quality Agreement Template
- Template for a supplier scorecard
- Managing nonconforming events
- Tools for improvement
Course Provider
Kelly Thomas,
