Supplier And Contract Manufacturer Management

• The benefits and components of a supplier management program
• Regulatory requirements for managing suppliers and contract manufacturers
• Strategic decision making for good supplier management
• How to manage risk and reduce the costs associated with having suppliers
• The steps involved in selecting and onboarding a supplier
• Developing good supplier relationships including managing improvement and nonconforming events
• Writing effective and useful quality agreements
• Reviewing supplier performance and making performance-based decisions
• How to perform a desktop assessment and a supplier audit (and when to use each)
• Managing supplier transitions

• Quality Assurance Personnel & Management
• Quality Control Personnel & Management
• Laboratory Supervisors
• Quality Engineers
• Procurement Professionals
• Drug Development Scientists
• Medical Device Development Scientists
• Supply Chain Personnel & Management

DAY 1 (10 AM to 3 PM)

10:00 AM - 11:30 AM | Session 1

Objectives:

• 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

DAY 2 (10 AM to 3 PM)

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

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.

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.