Supply Chain Compliance for Life-Science Companies

Supply chains for life-sciences 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 supply chain for life sciences companies will help them to 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 training 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: Optimal Clinical Supply Planning for Global Drug Development
Module 2: Building and institutionalizing risk management into the pharmaceutical supply chain
Module 3: China: Compliance Processes for Life Science Products (Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations)
Module 4: Understanding the Pharmaceutical Supply Chain in China Risks, Rewards, Solutions
Module 5: Managing the Medical Device Supply Chain – As per GHTF guidance document
Module 6: Securing your international supply chain:What heparin and DEG have to teach us

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 : Optimal Clinical Supply Planning for Global Drug Development (Duration: 60 minutes)

This training will discuss how to manage supply chain risk to optimize clinical trial supply and also manage demand side requirements, risk of stock out, cost management etc using novel tools and technologies.

Areas Covered in the Webinar:

• Overview of clinical supply planning techniques and tools
• Clinical supply optimization model
• Clinical supply network structure
• Clinical supply optimization tool components
• How the tool works
• Sites demand predictions
• Sites demand uncertainty
• Case study
• Risk management in clinical supply
• Clinical supply simulation as a prime tool for supply risk analysis
• Experiments with clinical supply simulation tool
• Combined usage of both optimization and simulation tools to derive optimal clinical supply plan

About the Instructor:

Vladimir Shnaydman, Ph.D,ORBee Consulting, President (2004 – current). The company' focus is design and development of analytical tools and techniques for optimization of business solutions for life science industries. Company also provides consulting service, utilizing capabilities of developed tools and techniques.

Vladimir has BS & MS Electrical Engineering & Computer Science, MS in Applied Mathematics & Operations Research, and Ph.D. in Engineering. He contributed to many industries such as biotechnology, computer networking, data storages, water resources planning and management, telecommunications, transportation, and others. Dr. Shnaydman published more than 50 papers. He is co-author of three books.

Module 2 : Building and institutionalizing risk management into the pharmaceutical supply chain (60 Minutes)

The training will explain how the pharmaceutical industry stakeholders can build and institutionalize risk management processes across the end-to-end supply chain, to secure compliant, risk mitigated supply chains able to compete on a world stage in terms of quality, cost and delivery performance.

Areas Covered in the Webinar:

• Understand the process of risk management as recommended by the International Conference on Harmonisation (ICH) guidance on Risk Management, ICH Q9, and the associated benefits of using such an approach.
• Be able to link their own particular circumstances to the wider product development and business environment risks, so as to maximise their own personal contribution to the organisation and also the contributions of colleagues.
• Have a clear understanding of the Regulatory expectations for risk management in the pharmaceutical industry of the 21st century.
• Develop an integrated view of risk through the application of powerful tools and processes that result in full ‘buy-in' to mitigation plans from key stakeholders.
• Take back to their work setting new approaches towards risk and ways of operating in project team and wider organizational issues.
• Learn how the application of supply chain management (SCM) competencies can dramatically reduce risk of failure in the supply chain.
• Feel far more confident that they understand risk management as an integral part of their regular operations, rather than an ad hoc event.

About the Instructor:

Hedley Rees, is author of “Supply Chain management in the Drug Industry” and is a practicing consultant, coach and trainer, operating through his company Biotech PharmaFlow. He helps companies build, manage and improve their clinical trial and commercial supply chains. Prior to his time at Biotech Pharmaflow, Hedley held senior supply chain management positions at Bayer, British Biotech, Vernalis, Johnson & Johnson and OSI Pharmaceuticals. He holds an Executive MBA from Cranfield University School of Management and is a corporate member of the UK's Chartered Institute of Purchasing and Supply (MCIPS).

Module 3 : China: Compliance Processes for Life Science Products (Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations) (90 minutes)

This training will discuss the regulatory structure and requirements for compliance with Chinese SFDA regulations for Pharmaceuticals, Medical Devices, Biologics and Combination Products.

Areas Covered in the Webinar:

• Country Profile / Healthcare System.
• Key Country Information.
• Strategic Considerations: Why China? / Asia Structure / Hub Locations.
• Governmental & Regulatory Authorities / Agencies / Structure.
• Company Establishment; Licenses & Key Personnel.
• Partner Companies / Local Relationship Options.
• In-Country Operational Considerations; Importance of Local Distributors
• Requirements to Conduct Clinical trials / Approvals / GCP
• Licensing Products ( Innovative Drugs , Generics / Similars, Orphan Drugs, Biologics / Vaccines, Medical Devices).
• Variations and Amendments to Licenses.
• GMP and Inspections.
• Packaging and Labeling.
• Price Establishment.
• Reimbursement.
• Import / Export / Customs Clearance.
• Taxes / Duties.
• Advertising & Promotion.
• Vigilance Reporting / Post-Marketing Requirements.
• Patents & Trademarks.
• Local Customs / Cultural Issues / Establishing Business Relationships.
• Working with Local Agencies / Authorities.
• Conclusions.

About the Instructor:

Robert J. Russell, (Bob) is the President of RJR Consulting, Inc. RJR Consulting Inc. specializes in understanding global regulatory issues for the pharmaceutical industry. Bob has more than 25 years of experience working with FDA and the Commission on technical issues as they relate to policy development, regulation, clinical trial and the medical device development process. Prior to entering the consulting field, Mr. Russell was the Global Director of Regulatory Affairs for two Fortune 100 firms.

Module 4 : Understanding the Pharmaceutical Supply Chain in China Risks, Rewards, Solutions (60 minutes)

This program will examine the benefits of outsourcing in China along with the risks and review possible solutions needed to enhance supply chain security while consistently delivering safe products to the consumer/patient.

Areas Covered in the Webinar:

• Current Environment of outsourcing in China. A look at actual product issues relating to recalls counterfeit product and product substitution.
• Why China and why outsourcing? A review of the parameters used to justify outsourcing your operations.
• A Review of the regulatory, quality, safety and oversight shortcomings that impact successful operations in China.
• A look at the various technical, regulatory and logistical solutions.
• A strategic Sourcing & Supply Chain Security solution needed for your success.

About the Instructor:

Richard Gaeto , Newcastle Strategic Partners provides integrated supply chain solutions to the Life Science Industry. Newcastle Strategic Partners has extensive Bio-Pharmaceutical and Medical Device experience in all aspects of the Supply Chain including strategy development and implementation, process improvement, systems integration, distribution, 3rd party logistics and more. Richard Gaeto, President of Newcastle Strategic Partners has worked with several of the leading biotechnology companies throughout his career leading Supply Chain Strategies for such companies as Centocor, Immunex, Amgen, Dendreon and ZymoGenetics.

Module 5 : Managing the Medical Device Supply Chain – As per GHTF guidance document (60 minutes)

This training will discuss how to control products and services from suppliers as per Global Harmonization Task Force (GHTF) guidance document. Also requirements for managing suppliers and the reasons for these requirements.

Areas Covered in the Webinar:

• The FDA’s medical device regulations for supplier control.
  • Evaluation of suppliers
  • Purchasing data
  • Items from the preamble
• ISO 13485:2003 purchasing requirements.
• The purchasing process
• Purchasing information
• Verification of purchased product
• Items from ISO/TR 14969:2004
• GHTF Guidance.
• Planning
• Selecting potential suppliers
• Supplier evaluation and selection
• Complete the control measures
• Delivery, measurement, and monitoring
• Feedback and correspondence
• Corrective action communication

About the Instructor:

Daniel O'Leary, is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Module 6 : Securing your international supply chain:What heparin and DEG have to teach us(60 minutes)

This training reviews case studies and describes actions that your firm should take promptly.

Areas Covered in the Webinar:

• Adulterated API: Heparin related deaths and Baxter’s recall of 2008.
• Pet food and melamine (2007).
• Cough syrup: 1937 and 2002.
• Root cause analysis.
• Steps toward improved oversight.
• Recent actions by governments, Congress, suppliers, and pharmaceutical manufacturers.

About the Instructor:

Paula Shadle, Ph.D., is the founder of Shadle Consulting, a firm that specializes in quality systems and process development for biopharmaceuticals. Dr. Shadle has over 20 years of hands-on and executive experience in biopharmaceutical process development and quality at firms including Chiron, Scios, GSK and Bayer. She has published over 40 publications and is co-inventor on 4 process patents. Dr. Shadle holds a Ph.D. degree in biochemistry from the University of California, and two years' postdoctoral experience at the Max-Planck-Institute. She is on the boards of the West Coast Chapter, PDA, and the East Bay Chapter, AWIS, and on the editorial board of BioPharm International.

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