PHARMA SUPPLY CHAIN,FDA EXPECTATIONS,(FDA/EMA/MHRA 2012 - Live webinar on INTEGRATING THE PHARMA SUPPLY CHAIN ACCORDING TO FDA EXPECTATIONS By compliance2go

Successful companies in leading sectors tend to exhibit a common characteristic ? they employ supply chains that are integrated in terms of both physical flow of materials and information. This allows them to build cultures and quality systems that continuously improve the ways they do business and deliver value to their customers. The pharmaceutical industry, for reasons which are made clear in the webinar, has not placed the same importance on the supply chain and is now suffering the consequences.

The main thrust of the session will be towards understanding what those successful companies (from industries such as semiconductor, automotives and aerospace) did to achieve integrated supply chains, how they continue to do it and what benefits they derive. It starts with the design & development stage, where supply chain foundations are laid and explores how supply chain management (SCM) competencies can and should be applied at this critical stage. Then it examines how SCM must permeate the organization for the full life-cycle of the product. The modernization initiates from FDA and ICH are translated into the language on modern production systems (such as Toyota Production System - TPS) and a plan for moving from what the Lean experts call a ‘process village’ to a value stream alignment is outlined. Finally, the session will pull together a cohesive account of the necessary cultural and organizational changes that must take place at both industry and company level to ensure sustainable supply chain performance improvement; this will be perfect ammunition to help talk to others within your organization to start a dialogue for change……….

Areas Covered in the Session:

? What the regulators (FDA/EMA/MHRA) are demanding of industry to increase supply chain integrity and control.

? The role of drug development (CMC) as a critical enabler of supply chain performance

? The power of supply chain management (SCM) when it integrates strategic procurement, production and inventory control, transportation and storage, information systems and improvement methodologies.

? How to build, manage and perfect the supply chain using Lean and Systems Thinking

? What you need to do the convince senior management of the need for change

? Driving meaningful change for the better (Kaizen)

Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

90 Minutes Live Presentation

Who will benefit: (Titles)

? Research chemistry and biochemistry
? Chemical and biochemical engineering
? Chemistry, manufacturing, and controls
? Preclinical development
? Clinical development
? Regulatory affairs
? Quality assurance
? Finance
? Marketing
? Informatics and information systems
? Business development
? Licensing
? Pharmacovigilance
? Purchasing
? Procurement
? Supply management
? Operations
? Production management
? Inventory management and control
? Production and material planning
? Demand planning
? Logistics
? Warehouse management
? Import/export
? SCM
? General management
? Investors ? VCs & private equity
? Lawyers

Why should you attend?

The Pharmaceutical supply chain is in trouble as never before. Supply chain shortages in the US have moved even the President to demand urgent remediation; high level congressional committees (eg the Health, Education, Labor and Pensions Senate Committee ?HELP) have also asked searching questions of FDA and other involved stakeholders, in an attempt to discover what has been going on with high profile supply chain failures. Companies such as J & J and Novartis are also writing off hundreds of millions worth of cost due to much publicized manufacturing issues.

Cargo theft, diversion and counterfeiting have become almost endemic, with detection and enforcement efforts stretched to the limit. Finally, and possibly most worrying of all, are the cases where materials have been adulterated or substituted with toxic alternatives (for economic gain) and have progressed undetected through one or more stages in the supply chain causing eventual patient death.

So what has gone wrong and how will it all pan out? We have to trace back to the 1970’s, when outsourcing of manufacture and distribution began in earnest; this was followed by a move towards off-shoring of key intermediates, APIs and even drug product. The result is we now have the most dis-integrated supply chain any industry sector has ever known. Without urgent remediation at the grass roots level, things are set to stay the same.

This webinar will provide attendees with a clear understanding of where the issues lay, and provide a structured road map to steer a path to move your supply chain to a new level of performance in terms of quality, cost and performance. This is achieved by exploring ways of working that move away from the mass production paradigm towards patient focused value streams

About Speaker

Hedley Rees is a practising consultant, coach and trainer, helping healthcare companies build, manage and continuously improve their clinical trial and commercial supply chains and risk profiles. He has his own company, Biotech PharmaFlow Ltd, based in the UK and handles assignments across the spectrum from top ten Pharma’s through to highly virtual early stage start ups. Prior to this, Hedley held senior supply chain positions at Bayer, British Biotech, Vernalis, Johnson & Johnson and OSI Pharmaceuticals. His skill set covers the range of supply chain management processes from strategic procurement, production and inventory control, distribution logistics, information systems and improvement. His specific interest is in driving industry improvements through the regulatory modernization frameworks of FDAs 21st Century Modernization and ICH Q8 ? Q10.Hedley holds an Executive MBA from Cranfield University School of Management and is a corporate member of the Chartered Institute of Purchasing and Supply (MCIPS). He is a member of the UK BioIndustry Association’s (BIA) Manufacturing Advisory Committee and also regularly speaks at international conferences, being co-chair of the 2011 FDA/Xavier University sponsored Global Outsourcing Conference in Cincinnati, October 2 -5. He has published in US and EU pharmaceutical journals and is author of “Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics” published by J. Wiley & Sons, Hoboken,