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      Supplier and Contract Manufacturer Management in Winter Park

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      February 6, 2020

      Thursday   8:30 AM - 4:30 PM (daily for 2 times)

      Winter Park, Florida 32789

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      Supplier and Contract Manufacturer Management

      Supplier and Contract Manufacturer Management
      About this Event


      Effective management of suppliers and contract manufacturers is an integral component of a quality management system. Suppliers are an integral part of the supply chain and, therefore, the process of production and delivery should by understood and supplier relationships developed and improved. Supplier failures can increase the cost of poor quality through excess inventory, downtime, additional testing, and customer satisfaction. On the other hand, a significant strategic advantage can be gained by excellent supplier management. One of the seven quality principles of ISO 9001 is to build relationships with suppliers because it is a critical component of sustained success.

      Pharmaceutical and medical device manufacturers have a mandated responsibility for ensuring the suppliers meet regulatory requirements and produce good quality product. FDA regulations CFR 210 and 211 require pharmaceutical companies to assure the quality of the product they put into interstate commerce regardless of where it or any of its components were manufactured. The Q10 Pharmaceutical Quality System Guidance provides additional details on the agency’s expectations for supplier management. For Medical Device Manufacturers, 21 CFR 820.50 places the burden on the purchasing company to establish purchasing controls. European regulations similarly require effective supplier quality management.

      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 do 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.

      Seminar Fee Includes:


      AM-PM Tea/Coffee

      Seminar Material

      USB with seminar presentation

      Hard copy of presentation

      Attendance Certificate

      $100 Gift Cert for next seminar

      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
      Areas Covered:

      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
      Who will benefit:

      In the pharmaceutical, medical device, cosmetic, or personal care industries: quality assurance managers, quality control laboratory supervisors, quality engineers, procurement professionals, drug development scientists, medical device development scientists, supply chain managers


      DAY 01(8:30 AM - 4:30 PM)

      8:30 AM - 8:59 AM Registration. Meet & Greet.

      9:00 AM -10:00 AM

      Introduction and Objectives for the course

      What are your expectations

      Agenda for the course

      The Benefits of Effective Supplier Management

      Case studies discussion

      Key Components of a Supplier Management Program

      10:00 AM - 10:10 AM Break

      10:10 AM -11:00 AM

      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

      11:00 AM -12:00 Noon

      Group Activity to Understand and Meet Regulatory Requirements

      The Cost of Poor Quality from Suppliers and CMs

      12:00 Noon -1:00 PM Lunch

      1:00 PM -1:50 PM

      To Purchase or to Manufacture In-house?

      Cost benefit exercise on making the decision to outsource

      Strategic Management of Suppliers

      Developing a strategic plan based on your company and environment

      1:50 PM - 2:50 PM

      Risk Management – A Lifecycle Approach

      Template for a risk assessment

      Case study with risk assessment exercise

      2:50 PM - 3:00 PM Break

      3:00 PM - 4:00 PM

      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

      Supplier qualification

      4:00 PM - 4:30 PM Daily Wrap-up and Discussion

      DAY 02(8:30 AM - 4:30 PM)

      8:30 AM - 8:59 AM Meet & Greet.

      9:00 AM -10:00 AM

      Seminar Objectives Review

      Building a Relationship with Your Supplier or CM


      Communications and documents

      10:00 AM -10:50 AM

      Making your Supplier Quality Agreement a Great Resource

      Quality Agreement Template

      Development of a Quality Agreement

      Using your Quality Agreement

      10:50 AM –11:00 AM Break

      11:00 AM -12:00 Noon

      Monitoring Your Supplier’s Performance to Reduce Risks and Costs

      Template for a supplier scorecard

      Activity on supplier performance monitoring

      Managing nonconforming events

      12:00 Noon -1:00 PM Lunch

      1:00 PM -2:00 PM

      Partnering with a Supplier or CM for Improvement

      Group improvement activity

      2:00 PM -2:10 PM Break

      2:10 PM -3:30 PM

      Supplier Assessments

      desktop assessments

      supplier audits

      3:30 PM -4:00 PM

      Handling Supplier Transitions

      4:00 PM - 4:30 PM

      Seminar Closeout


      Peggy Kwoka

      Senior Consultant, Quality GMP Solutions, LLC

      Peggy Kwoka has more than thirty years of experience in pharmaceutical, cosmetic consumer health and medical device industries including twenty years in Quality Assurance management and consulting. She has managed or provided expertise for more than ten US FDA inspections.

      Peggy is currently working with pharmaceutical companies to develop effective quality systems through her consulting firm, Quality GMP Solutions, LLC. She focuses on improving her client’s manufacturing and quality processes to enhance their regulatory compliance profile. She previously held quality assurance management roles at Colgate-Palmolive Company and GlaxoSmithKline.

      Cost: $1,889

      Categories: Conferences & Tradeshows

      This event repeats daily for 2 times:

      Event details may change at any time, always check with the event organizer when planning to attend this event or purchase tickets.

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