Implementing Robust Supply Chains

Implementing Robust Supply chains for life-sciences companies are important now and growing in importance as device manufacturers outsource products and services low cost destinations it is becoming longer, more diverse, and more difficult to control. The medical device manufacturer, however, has the ultimate responsibility for the product, so supply chain management becomes a critical function. As part of their Quality Management System (QMS) requirements, manufacturers must evaluate, select, and monitor suppliers.

This training package on implementing robust supply chain will help you understand the regulatory requirements for their supply chain planning, processes, risk management and how to stay compliant per FDA norms.

How It Works:

Each training CD has a series of modules. Our speakers have delivered the modules using PowerPoint slides.

This training is convenient to attend individually or in groups. You don’t have to travel from your office. This means you can afford to have your whole team attend. As the webinar recording CDs are licensed to be used multiple times in a location, you can schedule the training as many times for as many groups/batches as you wish. Your team members will learn the material together; everybody will get the same information.

Training Topics:

Module 1: Problem Solving and the Lean Supply Chain
Module 2: Lean Six Sigma and Supply Chain: Convergence
Module 3: Supplier Qualification and Oversight: How to Cope with a Global Supply Chain
Module 4: Supplier Quality Assurance Agreements: Why a General Supply Agreement May Not Be Enough with Some Suppliers
Module 5: Training on Supply Chain Finance
Module 6: Understanding, Detecting, and Reducing Supply Chain Fraud
Module 7: Control of Products and Services Obtained from Suppliers

Who will Benefit?

• Supply Chain Personnel
• All Clinical Professionals
• Research chemistry and biochemistry
• Finance
• Personnel involved in Trade and Logistics from pharma and drug companies
• Manufacturing, and controls
• Regulatory affairs
• Quality assurance
• Marketing, Business development
• Pharmacovigilance
• Purchasing, Procurement, Supply management and Logistics
• Warehouse management
• Transportation & Logistics
• Regulatory

Training Iincluded in the Package:

Module 1 : Problem Solving and the Lean Supply Chain (Duration: 60 minutes)

Through practical instruction and hands-on application, participants also learn to focus on the source of problems, determine the level of corrective action and how to work effectively with suppliers to prevent CAPA recurrences.

Areas Covered in Training CD:

• Escalate and prioritize problems so an appropriate level of investigation and corrective action is enabled.
• Partner with your suppliers to effectively solve problems (corrective action applied at the root of the problem) throughout the value stream.
• Build consistency in approach and efficiency in communication within your problem solving process.

About the Instructor:

Chris Tsai,is a Quality Expert for PathWise, a training and consulting firm in the areas of quality and compliance.A senior associate, manages training and consulting projects for manufacturing and life science industry organizations. He brings a rich understanding in CAPA, Six Sigma, Lean deployment and related change management techniques. Prior to partnering with PathWise, Chris spent 21 years with the Eastman Kodak Company in a variety of roles ranging from tooling and product design to manufacturing engineering to training development and delivery. His achievements span both Life Science and Technology businesses.

Module 2 : Lean Six Sigma and Supply Chain: Convergence (90 Minutes)

In this Lean six sigma training we will explore what early adopters are doing – and what is on the horizon and a brief history of the evolution both LSS (Lean Six Sigma) in SCM (Supply Chain Management).

Areas Covered in Training CD:

• A brief history of the evolution both LSS in SCM in the last 10 years.
• The need for balance and a holistic, forward thinking application of LSS and other process improvement methodologies in SCM – understanding waste and variation in supply chains and the key intersects of LSS tools in SCM.
• Key skill for leaders in supply chain – process and Value Stream Mapping.
• What to consider in preparing for the implementation of LSS in SCM – are you ready?
• A five-phase program for deploying LSS in SCM.

About the Instructor:

Ron Crabtree, CPIM, CIRM, CSCP, MLSSBB is an internationally recognized expert and author in cutting-edge business process improvement methodologies. He has personally mentored thousands of people in hundreds of organizations on ‘getting it right’ in continuous improvement. He serves as adjunct faculty for the University of San Francisco in Supply Chain Management and for Villanova University developing and teaching Lean Six Sigma and other programs.
Mr. Crabtree has co-authored three books on Lean Six Sigma including a text for the Villanova University Lean Six Sigma program and the LSS (Lean Six Sigma) Primer – published by the Quality Council of Indiana. He also writes in multiple publications including the “Lean Culture” Department in APICS Magazine for APICS, The Association for Operations Management (www.APICS.org); the global leader and premier source of the body of knowledge in operations management.

Module 3 : Supplier Qualification and Oversight: How to Cope with a Global Supply Chain (60 minutes)

This supplier qualification training will discuss on strategy to apply to QC testing and QA oversight, that helps to assure suitable quality of raw materials/excipients, and how to detecting fraud.

Areas Covered in Training CD:

• A strategy to apply to QC testing and QA oversight, that helps to assure suitable quality of raw materials/excipients, and some tips on detecting fraud.
• Assessing relative risks of different materials.
• How to qualify high-risk materials with suitable QC testing.
• Approaches to auditing the supply chain.
• What does supplier qualification really mean?
• What not to do.
• How to train auditors and supply chain professionals.

About the Instructor:

Paula Shadle, Ph.D., a quality and process development consultant has over 20 years of hands-on and executive experience in biopharmaceutical and pharmaceutical process development and quality, over 45 publications and 4 process patents. Is a member of the Parenteral Drug Association, the American Chemical Society, the Association for Women in Science, and the California Separations Society (CaSSS). Dr. Shadle has provided GMP training for numerous firms as well as the University of Wisconsin, and gives frequent audio seminars.

Module 4 : Supplier Quality Assurance Agreements: Why a General Supply Agreement May Not Be Enough with Some Suppliers (75 minutes)

This training will provide you the information you need to create supplier quality agreements (QA Agreements) with key suppliers and to understand which of your suppliers should have these agreements to meet expectations of the FDA and ISO 13485 Notified Body auditors.

Areas Covered in Training CD:

• The types of suppliers that should have QA Agreements to assure FDA and ISO 13485 compliance.
• Explanation, and use of the Global harmonization Task Force s (GHTF) and NBOC supplier guidance documents to create QA agreements.
• How to create supplier QA agreements and the best way to implement them.
• Definition of and requirements for Critical suppliers.
• Supplier agreements best practices.

About the Instructor:

Betty Lane , has over 30 years experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems for both FDA and ISO 13485 compliance band business when they became FDA and industry requirements. Her are areas of expertise include training, auditing, supplier management, design controls, software validation and general safety.

Module 5 : Training on Supply Chain Finance (90 minutes)

This training will examine the origins of supply-chain finance, the current state, and the projected future and its impact on importers, exporters, and banks.

Areas Covered in Training CD:

• The Predecessors of Supply-Chain Finance
• Letters of credit
• Trade acceptances and forfaiting
• Purchase order tracking
• Payables extension programs
• Challenges
• The SEC opinion on bank debt
• Security interest laws in countries of suppliers
• “True sale” laws
• Pre-export financing
• The Current Playing Field
• Domestic programs
• Purchase order-invoice matching applications
• Bank Payment Obligations (“BPOs”)
• On-line trade acceptances
• Value-dated payment orders
• Export Credit Agency and Multilateral Development Bank support

About the Instructor:

Walter (Buddy) Baker, has over 30 years of experience in international trade finance. In May 2009 he joined Fifth Third Bank where he heads their Global Trade Solutions Delivery team. Fifth Third is one of the 20 largest banks in the US and provides a full range of risk mitigation and financing products for exporters and importers. Prior to Fifth Third, Buddy worked for Atradius Trade Credit Insurance, ABN AMRO Bank, Bank of America, Wachovia Bank, and The First National Bank of Chicago.

Module 6 : Understanding, Detecting, and Reducing Supply Chain Fraud (60 minutes)

This Supply chain training shows how the supply chain is both external and internal to a company’s operations, and how setting up operations as an internal supply chain may be beneficial.

Areas Covered in Training CD:

• What is the supply chain?
• What is fraud?
• Frauds in the supply chain
• Helpful technologies to close data gaps
• Detection methods
• Examples

About the Instructor:

Norman Katz, CFE , In January 1996, after a 10-year IT career from programmer to IT Manager in his last three years (during which time a primary responsibility was supply chain vendor compliance business practices and technologies), Norman Katz founded Katzscan Inc., specializing in barcode applications (inventory control, fixed asset management, manufacturing, compliance labeling, etc.), Electronic Data Interchange (EDI), and both upstream and downstream supply chain vendor compliance. Norman has expanded his services to include data conversion and data reporting services, ERP systems, and general systems selection and implementation services.

Module 7 : Control of Products and Services Obtained from Suppliers (90 minutes)

This training will explore the regulatory requirements for supplier controls by medical device manufacturers and will review the recommendations by the GHTF for manufacturers of medical devices.

Areas Covered in Training CD:

• Supplier Controls reduce supplier problems.
• Supplier evaluation techniques lead to selection of better suppliers.
• Supplier selection processes must be effective in choosing the right suppliers.
• Acceptable Supplier Listings are used to show what products suppliers can efficiently provide.
• Removing suppliers from Acceptable Lists when there are issues.
• Impact of Risk Management on Supplier processes.
• How to develop a Supplier Management process that meets regulators expectations.
• Supplier contracts must have several key elements to meet regulatory requirements.

About the Instructor:

Edwin L. Bills, is the Principal Consultant for Bilanx Consulting LLC, a consulting firm that provides assistance to medical device companies in compliance with US FDA regulations, in development of Quality Management Systems and Risk Management processes. Edwin has over 20 years experience in the medical device industry and has participated in development of industry standards, including ISO 14971. In his consulting role he has assisted companies in Warning Letter responses. Edwin has also participated in training both company and FDA personnel in the Quality System Regulation and Product Risk Management.

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