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                       ACCORDING TO FDA EXPECTATIONS
 Wednesday, July 11, 2012 duration : 12:30 to 14:00 PM EDT


                                         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
Get 15 % Discount as a early bird        business and deliver value to their customers. The
registrations. Use Promo Key :           pharmaceutical industry, for reasons which are
 CGO15                                   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
Pricing                                  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
Live ( Single registration ) : $189.00   organization for the full life-cycle of the product.
Group ( Max 10 Attendee): $249.00        The modernization initiates from FDA and ICH are
On Demand (Recording available):$289     translated into the language on modern production
Get Training CD : $399                   systems (such as Toyota Production System -
Who will benefit                         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
    Who will benefit: (Titles)               together a cohesive account of the necessary
                                             cultural and organizational changes that must
   Research chemistry and biochemistry      take place at both industry and company level to
   Chemical and biochemical engineering     ensure sustainable supply chain performance
   Chemistry, manufacturing, and controls   improvement; this will be perfect ammunition to
   Preclinical development                  help talk to others within your organization to start
   Clinical development                     a dialogue for change
   Regulatory affairs
   Quality assurance                        Why should you Attend :
   Finance
   Marketing                                The Pharmaceutical supply chain is in trouble as
   Informatics and information systems      never before. Supply chain shortages in the US
   Business development                     have moved even the President to demand urgent
   Licensing                                remediation; high level congressional committees
   Pharmacovigilance                        (eg the Health, Education, Labor and Pensions
   Purchasing                               Senate Committee –HELP) have also asked
   Procurement                              searching questions of FDA and other involved
   Supply management                        stakeholders, in an attempt to discover what has
   Operations                               been going on with high profile supply chain
   Production management                    failures. Companies such as J & J and Novartis
   Inventory management and control         are also writing off hundreds of millions worth of
   Production and material planning         cost due to much publicized manufacturing issues.
   Demand planning
   Logistics                                Cargo theft, diversion and counterfeiting have
   Warehouse management                     become almost endemic, with detection and
   Import/export                            enforcement efforts stretched to the limit. Finally,
   SCM                                      and possibly most worrying of all, are the cases
   General management                       where materials have been adulterated or
   Investors – VCs & private equity         substituted with toxic alternatives (for economic
   Lawyers                                  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
Areas Covered in the Session:               of working that move away from the mass
                                            production paradigm towards patient focused
·      What the regulators                  value streams
(FDA/EMA/MHRA) are demanding of
industry to increase supply chain
integrity and control.
                                            About Speaker

·     The role of drug development          Hedley Rees is a practising consultant, coach and trainer,
(CMC) as a critical enabler of supply       helping healthcare companies build, manage and
chain performance                           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
·      The power of supply chain
                                            through to highly virtual early stage start ups. Prior to
management (SCM) when it integrates
                                            this, Hedley held senior supply chain positions at Bayer,
strategic procurement, production and
                                            British Biotech, Vernalis, Johnson & Johnson and OSI
inventory control, transportation and
                                            Pharmaceuticals. His skill set covers the range of supply
storage, information systems and
                                            chain management processes from strategic
improvement methodologies.
                                            procurement, production and inventory control,
                                            distribution logistics, information systems and
                                            improvement. His specific interest is in driving industry
                                            improvements through the regulatory modernization
·     How to build, manage and perfect
                                            frameworks of FDAs 21st Century Modernization and ICH
the supply chain using Lean and
                                            Q8 – Q10.Hedley holds an Executive MBA from Cranfield
Systems Thinking
                                            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
·     What you need to do the               Association’s (BIA) Manufacturing Advisory Committee
convince senior management of the           and also regularly speaks at international conferences,
need for change                             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
·      Driving meaningful change for the    Management in the Drug Industry: Delivering Patient
better (Kaizen)                             Value for Pharmaceuticals and Biologics” published by J.
                                            Wiley & Sons, Hoboken, New Jersey.
                           Compliance2go |
                           Phone : 877.782.4696 | Fax : 281-971-0286
                             Email :

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