It is an exciting time in the supply chain arena! In this webinar, the featured speaker will explore actions an organization can undertake to identify potential supply chain gaps today and to predictively identify trends that may lead to future supply chain disruption. The speaker will discuss key areas for supply chain strategies: Operational Readiness Assessment, Business Continuity Planning and adoption of Advanced Analytics as a methodology for determining supply chain decisions.

Over three years after the onset of COVID, supply chains are slowly starting to recover from its devastating impact. The ability to obtain medical commodities, raw materials, even transport and equipment is slowly beginning to normalize — that is to the ‘new’ normal, not at pre-pandemic levels. Although the backlog of ships at anchor outside of the ports of Long Beach and Los Angeles has not disappeared, improvements have been made in the availability of resources (drivers, equipment, 24-hour unloading) needed to offload and deliver goods. Efforts to onshore or near-shore raw materials are underway — but meaningful results are still in the future. Exporting countries continue to experience human resource shortages but have been able to open their borders to reduced production. Adopting supply chain strategies can greatly optimize this process.

Operational Readiness (OR) Assessment

An operational readiness assessment is one method of supporting a vertical startup by analyzing where each workstream of a Life Sciences organization stands relative to GMP manufacturing. It is a structured way to identify a company’s gaps against regulatory and business requirements and to ensure that commercial manufacturing is operationally ready to meet market demand.

Supply chain is an element of the OR exercise that includes all activities; from purchasing strategy to on-time and in-full delivery of customer orders. A closer look at the supplier management process (within the supply chain) is also needed to identify specific supplier vulnerabilities. An end-to-end supplier management review would include purchasing strategy through supplier selection and qualification as well as monitoring of supplier performance.

Business Continuity Planning (BCP)

When consulting with organizations, their business continuity planning often only includes instructions for what to do in case of facility and IT systems loss due to unplanned events such as fire or natural disaster. These BCPs tend to be placed into a binder at the corporate level and rarely reviewed or updated to include changes to business processes or the physical plant.

The BCP of today should be comprehensive, include risk and business impact assessments, have a periodic review, include a Recovery Plan based on identified risks and be supported by senior leadership. A best practice would include a mock event response to identify anything that may have been forgotten when developing the Business Continuity Plan and the Recovery Plan. A mock event exercise is like a mock audit exercise — planned practice to evaluate procedures before an actual disruption occurs. A BCP may become part of the organization’s overall risk management program, but care should be taken to clearly differentiate between business risk and product/patient risk.

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Advanced Analytics (AI)

Advanced, predictive analytics are the key to identifying supply chain trends and shortening the time needed to react to unplanned events. As mentioned previously, historical analytics (lagging indicators), such as sales ratios, inventory turnover, number of stockouts are often used to determine inventory and safety stock levels. While important, history alone is not actionable; what is needed for robust supply chains now are forward-looking analytics (predictive indicators) that can leverage organizational data to determine the best (optimal) supply chain planning decisions. Supply chain programs that make use of advanced analytics such as artificial intelligence (AI), and machine learning (ML) can optimize an organization’s supply chain.

Register for this webinar to learn more about key supply chain strategies — with recommendations for how to implement operational readiness assessment, business continuity planning, and potential uses for advanced analytics.

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Speaker

Kelly Smeltzer, Principal Consultant, CAI

Kelly Smeltzer is a Principal Consultant with over 30 years of experience in the fields of risk management, regulatory compliance, cGMP audit, logistics, supply chain, manufacturing and quality process improvement. Kelly has managed multiple successful cross-functional teams for a variety of activities including site remediation, audit preparation and response, Quality Risk Management and Quality Management Systems development and implementation. Kelly is Lean Six-Sigma and Six-Sigma Greenbelt Certified from Villanova University, an ASQ Certified Quality Auditor, a member of ASCM and has extensive project management, regulatory compliance and remediation expertise across a variety of pharmaceutical and device manufacturing operations.

Message Presenter

Who Should Attend?

Supply chain professionals
Purchasing agents
Manufacturing facilities professional
Operations professional
Warehousing/distribution professional
Pharmaceutical/device executive
Project manager
Quality systems professional
Regulatory professional
Supplier
Young professionals
Startup companies
Mature companies

What You Will Learn

Attendees will learn about:

Operational Readiness
Business Continuity Planning and
Advanced Analytics as they relate to supply chain

Xtalks Partner

CAI

Since CAI was founded in 1996, we have delivered over half a billion dollars in services for hundreds of clients across thousands of projects around the world. With offices in the US, Canada, Australia, Netherlands, Korea, Switzerland, Ireland, Italy, China, India, Singapore, and Malaysia, we have built an international team of over 750 professionals providing local support from a global company. Our engineering, technical, and consulting services are fashioned purposefully to develop mission critical facilities at a high level of performance and reliability. When operational readiness and startup are critical, CAI helps deliver to a higher standard.