10:00 AM - 11:30 AM
Session 1

- The Benefits of Effective Supplier Management
- Case studies discussion
- Key Components of a Supplier Management Program
- Introduction and Objectives for the course
- What are your expectations

Understanding Regulatory Requirements and Standards for Supplier and Contract Manufacturer (CM) Management:
- United States Food and Drug Association (FDA) regulations and guidances
European Union (EU) directives and guidelines
- International Standardization Association (ISO) standards
- Examples of regulatory findings

* Includes break

11:30 AM - 12:45 PM
Session 2

The Cost of Poor Quality from Suppliers and CMs:
- How to speak management’s language

Strategic Management of Suppliers:
- Developing a strategic plan based on your company and environment
- To Purchase or to Manufacture In-house?
- How to handle a make/buy decision

* Includes break

12:45 PM - 02:00 PM
Session 3

Risk Management – A Lifecycle Approach:
- Template for a risk assessment

Supplier qualification:
- Selecting a Supplier or Contract Manufacturer
- Obtaining information on suppliers
- Tools for making the selection
- How to use your strategic plan to make decisions
- When to use a sole source supplier

*Daily Wrap-up and Discussion

10:00 AM - 11:30 AM
Session 4

Supplier qualification:
- Building a Relationships with a Supplier or Contract Manufacturer

Making your Supplier Quality Agreement a Great Resource:
- Quality Agreement Template
- Development of a Quality Agreement
- Using your Quality Agreement

* Includes break

11:30 AM - 12:45 PM
Session 5

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

12:45 PM - 02:00 PM
Session 6

Supplier Assessments:
- Desktop assessments
- Supplier audits
- Handling Supplier Transitions

*Seminar Closeout