The "Supplier And Contract Manufacturer Management Course" training has been added to ResearchAndMarkets.com's offering.

This comprehensive supplier management course is designed to enhance your skills in effectively managing supplier relationships throughout their lifecycle. From supplier identification and qualification to building strong relationships, risk management, continuous assessment, and exit planning, this course covers it all.

Learn how to leverage risk assessment techniques to rank suppliers and minimize the need for extensive audits. Gain valuable insights into determining whether a supplier is suitable for sole sourcing. Engage in practical exercises to create your own customized supplier scorecard tailored to your company's requirements and develop quality agreements that promote clear communication. Walk away equipped with strategies for ongoing supplier process performance monitoring and efficient management of nonconforming incidents and changes.

Learning Objectives:

• Understand the benefits of effective supplier management
• Learn about the regulatory requirements for supplier management
• Understand how to develop a strategy for suppliers based on your supply chain
• Be able to analyze the cost of manufacturing vs. purchasing
• Understand how to select a supplier or contract manufacturer
• Understand the basics of building a supplier relationship
• Be able to develop a quality agreement that provides valuable guidance
• Learn how to perform risk assessments on suppliers and how to make decisions based on that assessment
• Learn how to develop a plan for supplier performance monitoring
• Understand how to manage failures and how to work with a supplier for improvement
• Understand the methods of supplier assessment and when to apply each
• Learn techniques for auditing a supplier and for follow-up and closure of the audit
• Learn how to effectively manage supplier exits and the transition to a new supplier

Who Should Attend:

• 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

Key Topics Covered:

DAY 1

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

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

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

DAY 2

Session 4

Supplier Qualification:

• Building 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

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

Session 6

Supplier Assessments:

• Desktop assessments
• Supplier audits

Handling Supplier Transitions:

• Transition strategies and continuity planning

Speaker

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.

He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.

For more information about this training visit https://www.researchandmarkets.com/r/eryrm4

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