Supply Chain Integrity and Security

Supply Chain Integrity and Security

The topic of supply chain integrity and security is relatively new in Pharma, having gained prominence in recent years for the reasons described above. Breach of security related to criminal activity is where the issues are most visible and enforcement activity is actively taking place around the globe. In parallel, if we are looking for sustainable, root cause solutions, we must also turn our attention to supply chain integrity and deal with both security and integrity concurrently.

An Oxford on-line dictionary definition of integrity is “the state of being whole and undivided”. Over the last 40 years, the Pharma supply chain has fragmented to the point where it is a million miles from that state. There are now multiple business models, such as virtual, biotech, specialty Pharma, innovator, generics, biosimilars, etc and a divergence of supporting actors, such a contract manufacturing organizations (CMOs), contract research organizations (CROs), central laboratories, third party logistics providers, pre-wholesalers, wholesalers, specialty pharmaceutical providers (SPPs) etc. As a result, our supply chains have dis-integrated to the point where visibility and accountability have become blurred at the edges – and it is this disintegration that has opened the doors to criminal activity and errors in quality outcomes.

The solution is not an easy one. It requires urgent action to mitigate activities of the ‘bad guys’, together with a longer term approach to ensure the ‘good guys’ get better at building and managing robust supply chains. This can only be achieved by collaboration between regulators, other enforcement agencies, technology providers and the industry itself. Where do we start?

We must initially focus on the end-to-end supply chain in its current state. Chains of custody and ownership must be clearly identified and remediation actions agreed by responsible parties to plug the gaps that currently exist. For example, Quality and technical agreements must become far more ‘process’ orientated so that they become working documents shared between business partners, rather than merely a static list of tick boxes. Change control has to work on upstream and downstream impacts that might affect supply chain integrity and procurement must forge supply agreements that impose obligations for supply chain visibility on prospective partners. This and much more needs to happen and will be discussed in the session.

Then we must turn attention to the building of supply chains for the future – the product development phase. This industry is unique in that the entire supply chain must be registered with competent authorities before approval to sell and post-launch changes have to be approved. This places a great responsibility on getting it right from the start. This is where the opportunity lay for sustainable improvements in the physical architecture of the supply chain and the underpinning management processes and information flows. A foundation for this has already been put in place by the regulators through FDA’s 21st Century Modernization initiative and ICH Q8 – 11 guidelines. The key to translating these initiatives into meaningful supply chain improvements, however, it in understanding the patient value proposition and the organizational/cultural elements that must firstly be in place, and these are explored in some depth.

Why should you attend: The Pharmaceutical supply chain has never been in such turmoil and under such attack from governments and regulators globally. The evidence is stark and mounting. Supply chain shortages in the US have moved even the President to demand urgent remediation; high level congressional committees 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. 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.

Areas Covered in the Session:

  • How to organize for supply chain integrity throughout the product life cycle
  • Current approaches to clamping down on criminal activity in the supply chain
  • Issues causing greatest concern to regulators and how to address them
  • Role of ICH Q8 – 11 in building robust supply chains
  • How the disciplines of procurement and supply chain management (SCM) can be leveraged
  • Role of technology as an enabler

Who Will Benefit:

  • Research chemistry and biochemistry
  • Chemical and biochemical engineering
  • Chemistry, manufacturing, and controls
  • Preclinical Development
  • Clinical Development
  • Regulatory Affairs
  • Quality Assurance

Speaker Profile

Hedley Rees is a practicing 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, New Jersey.

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How is Risk Management Important to Project Success?

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The answer to how risk management is important to project success is best illustrated by the fact that no project has ever succeeded without proper risk management. In other words, project management into which risk assessment has not gone in is as good as a doomed one.

Risk management’s importance to project success can never be overstated. Success at any project is unthinkable and unimaginable without proper and critical risk management. Risk management is a means by which the risks that accrue into a project are foreseen, assessed and mitigated, so that the project does not run into hitches at later stages, from where it would be all but impossible to rectify the same.

Understand what risk is, first

risk-management-important-to-project-successThe answer to the question of how risk management is important to project success has to start with a basic understanding of risk. In the context of project management, risk, as we all know, is the occurrence of a danger or an unwanted, undesired event in a project. It succeeds or is the next stage of a hazard, which is described as the potential for or the possibility of an event to cause danger.

How risk management is important to project success is to be understood from the standpoint of the fact that absolutely every activity, not only something concerning project management, has a risk. There are risks in simple and completely mundane activities such as brushing one’s teeth or putting a baby to sleep.

Diligence and thoroughness are important elements of risk management

risk-management-important-to-project-successIn order to manage a project successfully, the first step is carrying out risk management thoroughly and diligently. Risk management, if done properly, is the first and most fundamental aspect of success in a project. It is mainly about taking identifying, analyzing and mitigating risks in a business vis-à-vis its strengths and weaknesses.

It is accepted in the discipline of risk management that risks cannot be completely eliminated. However, having a sound risk management plan helps to anticipate and be prepared for risks. The ways in which this is done mainly depends on the kind of project which the organization is carrying out, and the risk manager’s ability to understand it in its fullness and implement risk mitigation strategies effectively.

Palpable benefitsRisk management’s importance to project success is illustrated by the following benefits of carrying out a Risk Analysis:

The stages of risk managementGiven the importance of risk management to project success; it is important to understand and implement risk management in its stages:

risk-management-important-to-project-successPlanning:This involves understanding the importance of risk management to project success by planning the risk management in terms of its size. It is generally true that the bigger the project from the operational, logistical and financial perspectives; the greater the risk, and vice versa.

Preparing: The next stage of risk management is to prepare for it. The right knowledge of the project in all its detail helps project managers to prepare for any exigency and for taking steps to mitigate its effects.

risk-management-important-to-project-successMeasuring the result: Judicious and farsighted project managers measure the fallout of a risk management activity by what it fetches. If a risk management activity has accrued a certain expense that cannot be justified in the light of the benefit it brought, then such a risk management action is not effective and has not understood the importance of risk management to project success.

Evaluating the impact: A risk management plan may have been planned, prepared and executed very diligently, but risk managers ask what impact such an action had on the project, and eventually, on the organization. How many resources did it consume? How much time did it take? What kind of risk did it mitigate and what was the impact of this risk, had it been allowed to continue? These are some of the questions insightful risk managers ask. This perceptiveness is a result of their sharp understanding of how work management is important to project success.

 

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Environmental, Health and Safety (EHS) Management and Audit

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An environmental, health and safety (EHS) management and audit program is now a prerequisite for organizations in various kinds of business. Allied to the emergence of and developing along with the concepts of worker safety and corporate social responsibility; the environmental, health and safety audit is today a major component of an organization. Organizations that need visibility and are desirous of earning a good name should make the environmental, health and safety management and audit a part of their culture.

The practice of companies auditing their environmental, health and safety (EHS) began in the 1970’s, almost contemporaneously with the enactment of OSHA. Around that time, the environmental issue was gaining ground in the corporate circles of the West with the governments and other agencies pitching in with their efforts to create greater awareness of the impact of business activities on the environment. As a result, the thinking that the top management of an organization needs to be viewing this issue more seriously started to develop and got ingrained over the years.

Cannot be glossed over
environmental-health-and-safety-management-and-auditAs a result of various legislations on the issue of environmental safety; the role of the Board of Governors became central in ensuring this aspect of the business. Environmental health and safety was no longer something that needed to be administered superficially, but in formal and designated ways, more specifically in the form of an audit. In order to incentivize corporate entities to implement environmental health and safety (EHS) management and audit; the trend started moving towards making these activities carry value addition to the organization.

Environmental health and safety management and audit is now a more formalized activity that needs to be carried out in a proper, set and well-defined manner. The processes that go into the EHS management and audit are clearly laid out in the form of standards such as the ISO 14001 standard, which is essentially an Environmental Management System (EMS) audit. To strengthen and enrich the audit activity and round it better; a few related and parallel standards such as the relevant parts of the 9000 family of standards, which deals with quality management, and 18000 series audits can be carried out with ease to supplement the environmental, health and safety audit.

Role of environmental health and safety (EHS) management and audit
environmental-health-and-safety-management-and-auditEnvironmental health and safety (EHS) management and audit have now evolved into being a practice that is coupled with and fused into many business-related activities. The practice now is to make an environmental health and safety management and audit an inseparable part of the Quality Management System. Environmental health and safety (EHS) management and audit audits are now a sure means to ensure that the organization has a reputation for corporate social responsibility by implementing this audit.

Aspects of an environmental health and safety management and auditThe aim of environmental health and safety management and audit is to instill the EHS right from the top management down to the line level employee. A properly carried out EHS management and audit system should ideally take these factors into consideration:

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Global Supply Chain Regulatory Compliance

Global supply chain regulatory compliance has become more important than ever before because of the confluence of a number of factors. As globalization becomes inevitable and inescapable, the global supply chain is one of the core arenas in which it plays out. The outgrowth brought about by globalization, namely outsourcing, has further increased the need for global supply chain regulatory compliance.

Global supply chain regulatory compliance has now become something on which organizations cannot compromise. Any shipment of any item that reaches foreign shores can get rejected if it has not met global supply chain regulatory compliance. Such a consignment could even get labeled as counterfeit. This explains the importance and need for global supply chain regulatory compliance. Being in global supply chain regulatory compliance means adhering to even the local laws of the foreign country into which goods and products are exported.

Governments have become more stringent 

global-supply-chain-regulatory-complianceAs a result of these trade and technological developments; governments all around the world without exception are jumping on the bandwagon to formulate laws that apply to the supply chain industry. For most governments, global supply chain regulatory compliance is a must. They are becoming extremely strict in enforcing these laws and are handing out severe punishments to businesses and organizations that are lax in enforcing global supply chain regulatory compliance. Most countries are legislating laws regarding global supply chains almost exclusively, in a way that other political acts are framed. This has pushed the need for global supply chain regulatory compliance further.

Other related developmentsAs technologies advance in the global supply chain, many developments in auxiliary and supplementary fields have hastened global the push for supply chain regulatory compliance requirements. For example, heavy paperwork, which used to be hallmark of most merchandising businesses, has made way for automation. Global supply chain regulatory compliance has to take factors such as these into consideration.

global-supply-chain-regulatory-complianceOther developments in allied areas such as intellectual property rights have gone on to strengthen the role of global supply chain regulatory compliance. As countries demand greater protection for their intellectual property products, they use global supply chain regulatory compliance as an instrument to enforce these, when these products concern exports.

In addition, there could also be other critically important issues in global supply chain regulatory compliance that may not be related to any of these, but can play a decisive role in disrupting global businesses. Think of natural disasters such as the Fukushima earthquake or the many natural disruptions such as hurricanes in South and North America. These could throw businesses out of gear. Global supply chain regulatory compliance is a kind of insulation against the uncertainties caused by events such as these.

In other words, global supply chain regulatory compliance should leave no stone unturned. There is no scope for compromise of any kind in implementing global supply chain regulatory compliance provisions.

Items that go into global supply chain regulatory complianceMeeting global supply chain regulatory compliance requirements means having to take care of a number of ingredients. Some of these are:

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Upcoming crucial global supply chain regulatory compliance regulation in the USSeveral legislations aimed at bringing about global supply chain regulatory compliance are in place. However, at this point of time, a really crucial global supply chain compliance regulation that could play a major role in the US in the coming years is the Automated Commercial Environment (ACE).

global-supply-chain-regulatory-complianceIn a nutshell, this U.S. Customs and Border Protection (CBP)-mandated regulation aims to bring in place a single portal which will make information on imported goods flow electronically from the businesses themselves right to the respective departments or agencies that require and handle them. The ACE is aimed at making import and export related work paperless, while also seeking to become a major facilitator of trade.

 

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Why Trade Compliance and Logistics Must Work Together

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Trade compliance and logistics must work together for a number of important reasons. While on the surface, trade compliance for logistics may seem burdensome for many organizations, the benefits of getting their trade compliance and logistics to work together are multifold and far outweigh the short term effort that goes into it, and that of noncompliance.

Undoubtedly, the most important reason for which trade compliance and logistics must work together is that they ensure that there is compliance with the laws of the countries into which the goods travel. It is a lot easier and a lot uncomplicated to have goods moving within national boundaries, where one can expect familiarity with the rules and the operating environment. In the case of global trade, the story is different.

Need to grapple with multiple laws

why-trade-compliance-and-logistics-must-work-togetherThere is great diversity and complexity of laws that govern trade compliance and logistics. They are now more integrated than at any point of time before because of the advent of new technologies. This brings in a motley mix of the elements of global business, such as currencies, laws, locations, people and so on. Businesses that have a stake in the global trade have to deal with these varieties and diffuse elements. One of the surest ways of ensuring that these are managed rightly is by getting trade compliance and logistics to work together.

Since there is a multitude of international laws that need to be complied with at many stages of the global supply chain; trade compliance and logistics must work together. This is the only sure way of ensuring that the company’s goods and products meet the required international trade guidelines and reach their destination safely.

A way out of the complexity

why-trade-compliance-and-logistics-must-work-togetherFor many in the business of exports, complying with the global supply chain may seem complex. However, knowledge of the laws of respective countries and building a sound logistics and supply chain infrastructure will go a long way in mitigating the problems associated with these. This is why trade compliance and logistics must work together.

Imagine a consignment of textiles originating somewhere in the Middle East headed for North America. This consignment has to pass through a few countries, at each of which it has to be sure it meets the compliance requirements. Finally, even when it reaches its destination, it must ensure that the laws of that country are complied with.

Increased efficiency and enhanced reputation 

why-trade-compliance-and-logistics-must-work-togetherAnother important reason for which trade compliance and logistics must work together is that there are substantial long term gains to be had by doing so. Supply chains that have come about as a result of trade compliance and logistics working together become more reliable and efficient. All these mean reduced costs in the long run, increased customer satisfaction, and enhanced reputation in the business.

Elaborating on the point above, it is also equally true that trade compliance and logistics must work together to pump up nations’ economic growth. A country that ensures that trade and logistics are in accordance with internationally legislated laws on the subject are more likely to be trusted by global businesses. Countries in which trade compliance and logistics work together and result in sound business infrastructure are naturally more preferred by businesses as transit routes or destinations for their products. This brings in substantial revenues to the countries.

 

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What is logistics and supply chain management?

Logistics and supply chain management (SCM) constitute a very important element of businesses. Getting the logistics and supply chain management aspects right is necessary for the smooth flow of products from their source to destination, during the course of which many activities need to be performed.

Logistics and supply chain management is emerging as a major area of business because of the evolution and growth of globalization. Many products and goods are produced in one country and consumed in another situated thousands of miles away. The right logistics and supply chain management helps to deliver the goods and products to the right person, at the right time, at the right place and in the right condition. Lack of proper logistics and supply chain management is a recipe for disaster.

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What is logistics and supply chain management?

 

Among the lay people, there is a tendency to use the two words synonymously and interchangeably. In trade, however, there are major differences between the two. Logistics is just a part of the supply chain. In simple, general and broad terms, one can understand the difference between logistics and supply chain in the following ways:

Logistics is a part of supply chain, meaning that it is a set of activities that are carried out within an organization. Supply chain, on the other hand, is the full set of activities that are carried out from start to finish, i.e., from the time it departs the organization that it is leaving till the time it reaches its logical destination. In this process, supply chain management involves the coordination and collaboration of many entities. In this sense, supply chain is a whole set of activities, of which logistics is only a part.

Another way of understanding logistics and supply chain management 

logistic-and-supply-chain-managementAnother way of understanding logistics and supply chain management is this:

Logistics can be understood as being a discipline in which the following activities are involved:

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On the other hand, supply chain management can be said to include more extended activities, which include:

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Logistics and its extended activitiesLogistics often is described in terms of inbound and outbound logistics. Simply put, inbound logistics is the movement of raw materials and goods that are bought by and transported into a company. When these are processed and finished and shipped to customers; they become part of outbound logistics.

Logistics and supply chain management in a broader contextWhen one tries to get an understanding of logistics and supply chain management at a higher or broader level in the way logistics has been described above; supply chain management can be understood as consisting of these elements:

logistic-and-supply-chain-managementA sound supply chain system seeks to create value for the organization by building and utilizing logistics infrastructure. Logistics and supply chain management become meaningful when the organization synergizes demand with supply, stock and supply and inventory management

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200+ followers. WOWWWWWW…

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Hello Everyone,

Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone.  we never expected to actually to connect with other people in the blogging community.

we are so incredibly thankful for each and every one of you who follows and comments on my blog posts. Please know that!

we would continue our blogging in these areas FDA Regulation, Medical Devices, Drugs and Biologics, Healthcare Compliance, Biotechnology, Clinical Research, Laboratory Compliance, Quality Management ,HIPAA Compliance ,OSHA Compliance, Risk Management, Trade and Logistics Compliance ,Banking and Financial Services, Auditing/Accounting & Tax, Packaging and Labeling, SOX Compliance, Environmental Compliance, Microsoft Excel Spreadsheet, Geology and Mining, Human Resources Compliance, Food Safety Compliance and etc.

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