2-Day Virtual Seminar

Dates: AUGUST 4 - 5, 2022
Time (Eastern Time US): 10 AM to 2 PM
Time (Central Europe): 4 PM to 8 PM

Duration: 2 DAYS

Course Director: JOSÉ  MORA

As Various parts of the world are still battling the Coronavirus (COVID-19), we are conducting the class 100% online.


José Mora

José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment. José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices. José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles. During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under José’’s leadership. He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.

This 2-day course will cover managing a supplier for the entire lifecycle of the relationship, beginning with identification and qualification of a supplier and continuing through building a relationship, risk management, ongoing assessment (including auditing) and finally planning for an exit. The course will show attendees how to use risk assessment for ranking suppliers and reducing the number of audits that are necessary to effectively manage suppliers. Strategies for determining whether a supplier will be sole source will be included. Exercises will help attendees develop their own supplier scorecard based on the requirements of their company and develop quality agreements that will ensure clear lines of communication. Attendees will take away strategies for the ongoing monitoring of supplier process performance and for managing 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

  • 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
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

2-Day Seminar on Supplier and Contract Manufacturer Management

  • Date: 8/4/2022 10:00 AM
  • Location Online Event


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