is being presented by Leigh Bailey, Founder & CEO, of The Bailey Group and airs on Thursday, February 16th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Technical leaders can be defined as those who are experts in a particular specialty (e.g. engineering, nursing, medicine, finance, law, or accounting), and whose career paths have changed from a technical/individual contributor track to a management track. In many cases, they are promoted to management because of their success as individual contributors – partly as a reward for their history of good work and partly because it is assumed they will teach their direct reports to be as gifted as they are at their technical specialty.
In such situations, it does not take long for problems to arise with newly appointed managers. Direct reports often claim that the new manager is a “micro manager” and they cannot do their work well enough to earn his or her praise. Peers may complain that the new manager is condescending, doesn’t listen, or jumps to false conclusions. Most damaging is when the new manager does not think anything is wrong and dismisses the feedback from his or her colleagues. Left unchecked, these situations often lead to the boss deciding that the “collateral damage” created by these new managers is too great and they are returned to their individual contributor role, ego and reputation badly damaged.
These kinds of situations are entirely avoidable, and this presentation looks at how to identify good candidates for technical leadership, how to spot individuals who are less likely to succeed, and how to work with existing technical leaders to maximize their chances for success.
Tuesday, January 31, 2012
Monday, January 30, 2012
The De Novo Petition – Is There Hope at FDA for Lower Risk, Innovative Devices?
is being presented by Michael A. Swit, Principal, with Law Offices of Michael A. Swit and airs on Wednesday, February 15th, 2012. For more details, or to register please visit our site at www.fxconferences.com
The 'de novo' 510(k) petition process presents a unique opportunity for medical device companies to bring products to the market without having to go through the more lengthy and expensive route of a Premarket Approval Application (PMA).
In 1997, recognizing that many innovative devices put into Class III presented lower risks, Congress revised the medical device laws to create the de novo petition. It allows a company to petition FDA to move a device that has been automatically classified into Class III to Class II or even Class I. While designed to relieve the regulatory burden on industry, the de novo petition process has presented many challenges. Less than 70 devices have successfully undergone the de novo process. And, the process is not easy. Before pursuing a petition, a firm must first file a 510(k) and have FDA deny the submission as not substantially equivalent.
In late 2011, FDA issued a new draft guidance on the de novo process, and legislation is pending that would streamline the system. This audio conference explores how to take advantage of the de novo process, challenges linked to the process and how to best position your petition for success.
The 'de novo' 510(k) petition process presents a unique opportunity for medical device companies to bring products to the market without having to go through the more lengthy and expensive route of a Premarket Approval Application (PMA).
In 1997, recognizing that many innovative devices put into Class III presented lower risks, Congress revised the medical device laws to create the de novo petition. It allows a company to petition FDA to move a device that has been automatically classified into Class III to Class II or even Class I. While designed to relieve the regulatory burden on industry, the de novo petition process has presented many challenges. Less than 70 devices have successfully undergone the de novo process. And, the process is not easy. Before pursuing a petition, a firm must first file a 510(k) and have FDA deny the submission as not substantially equivalent.
In late 2011, FDA issued a new draft guidance on the de novo process, and legislation is pending that would streamline the system. This audio conference explores how to take advantage of the de novo process, challenges linked to the process and how to best position your petition for success.
Friday, January 27, 2012
The Food Safety Modernization Act – What It Really Means (And What It Doesn't)
is being presented by Benjamin L England, Founder and CEO, of FDAImports.com and airs on Wednesday, February 15th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Since its introduction, the Food Safety Modernization Act has been discussed, written about and portrayed ad infinitum, often out of any sensible context to the actual realities of importing and manufacturing. Hyperbole aside, what does it really mean for you and your company?
With this timely audio conference presentation, former FDA veteran Benjamin England brings a much-needed reality check to the FSMA conversation. The presentation looks at what FSMA implementation this year will likely consist of, and what specific issues are likely to arise based on these new rules in a real-world context. For manufacturers, companies and distributors this means valuable insight into which changes should be of concern, what can safely be ignored, what they can expect in the coming months, and how best to prepare. Mr. England devotes special attention to the implementation dates for 2012, and provides attendees with an opportunity to ask questions specific to their situation.
Since its introduction, the Food Safety Modernization Act has been discussed, written about and portrayed ad infinitum, often out of any sensible context to the actual realities of importing and manufacturing. Hyperbole aside, what does it really mean for you and your company?
With this timely audio conference presentation, former FDA veteran Benjamin England brings a much-needed reality check to the FSMA conversation. The presentation looks at what FSMA implementation this year will likely consist of, and what specific issues are likely to arise based on these new rules in a real-world context. For manufacturers, companies and distributors this means valuable insight into which changes should be of concern, what can safely be ignored, what they can expect in the coming months, and how best to prepare. Mr. England devotes special attention to the implementation dates for 2012, and provides attendees with an opportunity to ask questions specific to their situation.
Thursday, January 26, 2012
Who Owns What? Patent Ownership Issues with the Exchange of Biotechnology
is being presented by Kattina V. Barsik, Esq. Intellectual Property and Registered Patent Attorney and airs on Tuesday, February 14th, 2012. For more details, or to register please visit our site at www.fxconferences.com
Institutions involved in the exchange of unique materials – including federal laboratories, industrial research laboratories, and laboratories in universities, hospitals, or independent research institutes – often have specific expectations regarding compensation for the help they provide. It may range from acknowledgment in a publication to ownership of inventions made with the aid of the provided material.
Industry defends its commercial interests vigorously, and seeks to offset risk by acquiring and protecting exclusivity in the marketplace through patent law or by use of trade secrets. In contrast, the federal government and its academic grantees look to preserve the flow of ideas for public benefit, primarily through timely publication, and to serve as the public's steward of inventions by preserving the potential for new knowledge to generate a product from which the public may benefit. The exchange of materials between universities and industrial laboratories is often difficult, and unlikely to be standardized in the near future.
This audio conference presentation discusses how to deal with these competing priorities, and craft terms which avoid conflict and allow all parties to benefit.
Institutions involved in the exchange of unique materials – including federal laboratories, industrial research laboratories, and laboratories in universities, hospitals, or independent research institutes – often have specific expectations regarding compensation for the help they provide. It may range from acknowledgment in a publication to ownership of inventions made with the aid of the provided material.
Industry defends its commercial interests vigorously, and seeks to offset risk by acquiring and protecting exclusivity in the marketplace through patent law or by use of trade secrets. In contrast, the federal government and its academic grantees look to preserve the flow of ideas for public benefit, primarily through timely publication, and to serve as the public's steward of inventions by preserving the potential for new knowledge to generate a product from which the public may benefit. The exchange of materials between universities and industrial laboratories is often difficult, and unlikely to be standardized in the near future.
This audio conference presentation discusses how to deal with these competing priorities, and craft terms which avoid conflict and allow all parties to benefit.
Wednesday, January 25, 2012
The UK Bribery Act– Upping the Ante on Anti-Corruption/Anti-Bribery Enforcement
is being presented by Jamie L. Kendall, Esq., Senior Director, with Compliance Implementation Services and airs on Thursday, February 9th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Since 1977, international pharmaceutical manufacturers have had to ensure their local affiliates abide by the Foreign Corrupt Practices Act (FCPA) when interacting with government officials. Just this past April, Johnson & Johnson came to settlement terms with the SEC for FCPA charges to the tune of $48.6 million stemming from allegations of bribing and providing kickbacks to public doctors in Europe and Iraq.
In 2010, the United Kingdom threw its hat into the anti-corruption/anti-bribery ring by enacting the UK Bribery Act, which went into effect July 1, 2011. In an interview with the Daily Telegraph the day it went into effect, the director of the UK Serious Fraud Office emphasized the intention to use the UK Bribery Act to go after non-UK corporations. While most companies may be familiar with best practices to avoid criminal investigations and civil penalties under the FCPA, the UK Bribery Act creates an additional layer of scope and raises the floor of compliance by including parties and actions not contemplated by the FCPA.
Pharmaceutical companies with UK connections will no longer be able to rely on anti-corruption policies and procedures that were predicated solely on FCPA compliance. Indeed, such policies and procedures must now account for the wider net that the UK Bribery Act casts. The enactment of the UK Bribery Act increases fraud and abuse risk exposure and an understanding of its provisions and how it differs from the FCPA is essential for creating a comprehensive compliance policy.
This presentation provides attendees with an overview of the differences between the UK Bribery Act and the FCPA and emphasizes the wider scope the UK Bribery Act represents in the anti-corruption/anti-bribery regulatory and legal framework.
Since 1977, international pharmaceutical manufacturers have had to ensure their local affiliates abide by the Foreign Corrupt Practices Act (FCPA) when interacting with government officials. Just this past April, Johnson & Johnson came to settlement terms with the SEC for FCPA charges to the tune of $48.6 million stemming from allegations of bribing and providing kickbacks to public doctors in Europe and Iraq.
In 2010, the United Kingdom threw its hat into the anti-corruption/anti-bribery ring by enacting the UK Bribery Act, which went into effect July 1, 2011. In an interview with the Daily Telegraph the day it went into effect, the director of the UK Serious Fraud Office emphasized the intention to use the UK Bribery Act to go after non-UK corporations. While most companies may be familiar with best practices to avoid criminal investigations and civil penalties under the FCPA, the UK Bribery Act creates an additional layer of scope and raises the floor of compliance by including parties and actions not contemplated by the FCPA.
Pharmaceutical companies with UK connections will no longer be able to rely on anti-corruption policies and procedures that were predicated solely on FCPA compliance. Indeed, such policies and procedures must now account for the wider net that the UK Bribery Act casts. The enactment of the UK Bribery Act increases fraud and abuse risk exposure and an understanding of its provisions and how it differs from the FCPA is essential for creating a comprehensive compliance policy.
This presentation provides attendees with an overview of the differences between the UK Bribery Act and the FCPA and emphasizes the wider scope the UK Bribery Act represents in the anti-corruption/anti-bribery regulatory and legal framework.
Tuesday, January 24, 2012
Patient Recruitment: How It's Broken and Five Ways to Fix It
is being presented by Sherry Reuter, President, of Sherry Reuter & Associates and airs on Wednesday, February 8th, 2012. For more details, or to register please visit our site at www.fxconferences.com
The numbers don't lie: clinical trial enrollment rates have dropped from 75% in 2000 to 59% in 2006 and retention rates have fallen from 69% to 48% during same period; delays in patient recruitment for clinical trials account for an average of 4.6 months lost per trial – an annual cumulative loss of 26 years, on average, for each company; 80% of total trials are delayed at least one month because of unfulfilled enrollment.
The bottom line? Patient recruitment as we know it just isn't working.
This audio conference presentation looks at the efforts currently used to reach recruitment goals, why they are ineffective, and why new approaches must be implemented. Our speaker shares specific strategies that can be easily implemented, and helps attendees understand the patient's perspective and how to use that awareness to make recruitment plans more effective.
The numbers don't lie: clinical trial enrollment rates have dropped from 75% in 2000 to 59% in 2006 and retention rates have fallen from 69% to 48% during same period; delays in patient recruitment for clinical trials account for an average of 4.6 months lost per trial – an annual cumulative loss of 26 years, on average, for each company; 80% of total trials are delayed at least one month because of unfulfilled enrollment.
The bottom line? Patient recruitment as we know it just isn't working.
This audio conference presentation looks at the efforts currently used to reach recruitment goals, why they are ineffective, and why new approaches must be implemented. Our speaker shares specific strategies that can be easily implemented, and helps attendees understand the patient's perspective and how to use that awareness to make recruitment plans more effective.
Monday, January 23, 2012
Medical Device Software – Regulatory Requirements and Issues
is being presented by Neil R. Armstrong, CEO, of MeddiQuest and airs on Tuesday, February 7th, 2012. For more details, or to register please visit our site at www.fxconferences.com
Healthcare is being revolutionized through the synergistic development of information technology and medical devices, and regulators are starting to realize that healthcare software cannot be ignored or adequately regulated by analogy to hardware alone. However, there is little consistency in the extent or content of new regulations being introduced.
This audio conference presentation is targeted at those involved in developing medical devices with software, or software to be used in a healthcare environment, who want a high-level overview of the regulatory landscape and a better understanding of current issues. Our speaker discusses the evolution of medical device software regulations, summarizing the current regulatory requirements in major markets. We also explore some forthcoming issues, and how current product development can be “future-proofed” against new regulations.
Healthcare is being revolutionized through the synergistic development of information technology and medical devices, and regulators are starting to realize that healthcare software cannot be ignored or adequately regulated by analogy to hardware alone. However, there is little consistency in the extent or content of new regulations being introduced.
This audio conference presentation is targeted at those involved in developing medical devices with software, or software to be used in a healthcare environment, who want a high-level overview of the regulatory landscape and a better understanding of current issues. Our speaker discusses the evolution of medical device software regulations, summarizing the current regulatory requirements in major markets. We also explore some forthcoming issues, and how current product development can be “future-proofed” against new regulations.
Tuesday, January 17, 2012
Improving Compliance and Patient Safety with Plain Language Authoring
is being presented by Kristina E. Anderson, EasyRead Writing LLC and airs on Wednesday, February 1st, 2012. For more details, or to register please visit our site at www.fxconferences.com
The Plain Writing Act of 2010 is the latest government effort to make complicated regulations easier to read and understand. "Plain language" refers to a method of authoring documentation in a straightforward, sensible, engaging and culturally appropriate manner. It makes the complicated easier to grasp. It tells readers what they need to know and nothing else. When done correctly, it ensures understanding and compliance and improves patient safety – and now it's the law! What plain language is not, is the "dumbing down" of information.
Authoring your documentation using plain language can result in a savings of both time and money by reducing mistakes and misunderstandings. However, successful implementation requires buy-in on an organization-wide level, and there can be some resistance to change. This audio conference presentation is designed to provide attendees with an understanding of what plain language is, how and why to start using it, and what the Plain Writing Act of 2010 means for your company. It also provides regulatory writers with the compelling information they need to convince managers that plain language authoring is a valid and necessary development in health care.
The Plain Writing Act of 2010 is the latest government effort to make complicated regulations easier to read and understand. "Plain language" refers to a method of authoring documentation in a straightforward, sensible, engaging and culturally appropriate manner. It makes the complicated easier to grasp. It tells readers what they need to know and nothing else. When done correctly, it ensures understanding and compliance and improves patient safety – and now it's the law! What plain language is not, is the "dumbing down" of information.
Authoring your documentation using plain language can result in a savings of both time and money by reducing mistakes and misunderstandings. However, successful implementation requires buy-in on an organization-wide level, and there can be some resistance to change. This audio conference presentation is designed to provide attendees with an understanding of what plain language is, how and why to start using it, and what the Plain Writing Act of 2010 means for your company. It also provides regulatory writers with the compelling information they need to convince managers that plain language authoring is a valid and necessary development in health care.
Monday, January 16, 2012
7 Critical FDA Expectations of Senior Management
is being presented by John Avellanet, Managing Director & Principal, with Cerulean Associates LLC and airs on Tuesday, January 31st, 2012. For more details or to register, please visit our site at www.fxconferences.com
The FDA is cracking down on corporate executives, using the Park Doctrine and the FDAAA to impose civil penalties, jail time and industry bans.
This audio conference presentation focuses on the things your management team needs to be doing on a regular, consistent basis to 'ensure the suitability and effectiveness' of your company's quality system. Our speaker, who is president of an independent review organization (IRO) for a current consent decree, provides insight on what FDA investigators and district officers expect to see from your management team. Attendees discover the crucial difference in the eyes of FDA between responsibility and accountability, and how it affects delegating work to staff and suppliers. The presentation also discusses how to ensure your management team is effectively and appropriately engaged, and what proof you need to provide the agency investigators.
The FDA is cracking down on corporate executives, using the Park Doctrine and the FDAAA to impose civil penalties, jail time and industry bans.
This audio conference presentation focuses on the things your management team needs to be doing on a regular, consistent basis to 'ensure the suitability and effectiveness' of your company's quality system. Our speaker, who is president of an independent review organization (IRO) for a current consent decree, provides insight on what FDA investigators and district officers expect to see from your management team. Attendees discover the crucial difference in the eyes of FDA between responsibility and accountability, and how it affects delegating work to staff and suppliers. The presentation also discusses how to ensure your management team is effectively and appropriately engaged, and what proof you need to provide the agency investigators.
Friday, January 13, 2012
Preparing for 2012: Regulatory Update for Device & Diagnostic Companies
is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Tuesday, January 31st, 2012. For more details, or to register please visit our site at www.fxconferences.com
2011 was quite a year for publishing proposed major changes to the regulatory framework for medical device and diagnostics manufacturers. It is likely that more certainty will be introduced during 2012 as to what the changes will be and how they will affect MD&D companies. The major topics include the 510K process in the US, the planned recast of the Medical Device Directives in the EU, potential changes to the informed consent process for sample collection in the US, planned changes to the monitoring guidance in the US, and the changes to the ISO 14155 standard issued in 2011.
In this audio conference, our speaker reviews the changes or proposed changes to the regulatory framework, discusses the implications for MD&D companies, and describe how best to plan for future changes. The presentation also provides pointers on when the changes currently in draft form are likely to be implemented. This audio conference is intended to summarize the 2011 regulatory landscape for MD&D companies, and help them prepare for 2012 and beyond.
2011 was quite a year for publishing proposed major changes to the regulatory framework for medical device and diagnostics manufacturers. It is likely that more certainty will be introduced during 2012 as to what the changes will be and how they will affect MD&D companies. The major topics include the 510K process in the US, the planned recast of the Medical Device Directives in the EU, potential changes to the informed consent process for sample collection in the US, planned changes to the monitoring guidance in the US, and the changes to the ISO 14155 standard issued in 2011.
In this audio conference, our speaker reviews the changes or proposed changes to the regulatory framework, discusses the implications for MD&D companies, and describe how best to plan for future changes. The presentation also provides pointers on when the changes currently in draft form are likely to be implemented. This audio conference is intended to summarize the 2011 regulatory landscape for MD&D companies, and help them prepare for 2012 and beyond.
Tuesday, January 10, 2012
Food Defense – Regulatory Requirements and New Developments
is being presented by William L Ramsey, Director of Security, with McCormick & Company and airs on Thursday, January 26th, 2012. For more details or to register, please visit our site at www.fxconferences.com
The safety and security of the food supply has come under intense scrutiny in the wake of 9/11. In the intervening years "food defense" has become an industry catchphrase. But what exactly does it mean? What do regulators want to see?
This audio conference presentation reviews the use of physical security practices in the food industry since the events of September 11, 2001 and the advent of the term “food defense”. Our speaker discusses current food defense expectations from both the USDA and FDA, and takes a look at some possible regulatory developments associated with the Food Safety Modernization Act of 2010.
The presentation provides key information on the use of threat assessments, vulnerability assessments and risk assessments, as well as the use of a “goal based” security model in the development of security and food defense plans for food manufacturing facilities. Attendees also learn about supply chain responsibilities, and ways to utilize national and international supply chain programs such as C-TPAT, AEO and PIP to enhance food defense measures.
The safety and security of the food supply has come under intense scrutiny in the wake of 9/11. In the intervening years "food defense" has become an industry catchphrase. But what exactly does it mean? What do regulators want to see?
This audio conference presentation reviews the use of physical security practices in the food industry since the events of September 11, 2001 and the advent of the term “food defense”. Our speaker discusses current food defense expectations from both the USDA and FDA, and takes a look at some possible regulatory developments associated with the Food Safety Modernization Act of 2010.
The presentation provides key information on the use of threat assessments, vulnerability assessments and risk assessments, as well as the use of a “goal based” security model in the development of security and food defense plans for food manufacturing facilities. Attendees also learn about supply chain responsibilities, and ways to utilize national and international supply chain programs such as C-TPAT, AEO and PIP to enhance food defense measures.
Monday, January 9, 2012
An Overview of Recent Risk-based Monitoring Guidance from the FDA
is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Wednesday, January 25th, 2012. For more details, or to register please visit our site at www.fxconferences.com
We have been waiting for an update on the FDA guidance on monitoring since 1988, and that update is finally here! This presentation reviews three FDA recent guidance documents about monitoring. Our speaker discusses the information provided in the 'Compliance Program Guidance Manual' for BIMO inspectors 'CHAPTER 48 – Bioresearch Monitoring' (CPGM 7348.810 for sponsors, CROs and monitors and CPGM 7348.811 for clinical investigators and sponsor-investigators) for foods, biologics, drugs and devices, which was implemented in March of 2011. The presentation also reviews the long-awaited 'Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring' which was released in August of 2011 to 'enhance human subject protection and the quality of clinical trial data.
These documents are designed to clearly articulate alternative practices for a “modern, risk-based approach” to monitoring, and attendees of this audio conference gain valuable insight on the changes, and the resulting opportunity to change the way monitoring is done in efforts to improve attention to human subject protection and high quality data.
We have been waiting for an update on the FDA guidance on monitoring since 1988, and that update is finally here! This presentation reviews three FDA recent guidance documents about monitoring. Our speaker discusses the information provided in the 'Compliance Program Guidance Manual' for BIMO inspectors 'CHAPTER 48 – Bioresearch Monitoring' (CPGM 7348.810 for sponsors, CROs and monitors and CPGM 7348.811 for clinical investigators and sponsor-investigators) for foods, biologics, drugs and devices, which was implemented in March of 2011. The presentation also reviews the long-awaited 'Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring' which was released in August of 2011 to 'enhance human subject protection and the quality of clinical trial data.
These documents are designed to clearly articulate alternative practices for a “modern, risk-based approach” to monitoring, and attendees of this audio conference gain valuable insight on the changes, and the resulting opportunity to change the way monitoring is done in efforts to improve attention to human subject protection and high quality data.
Friday, January 6, 2012
Collecting Post-Market Device Data Without Running Afoul of FDA
is being presented by Robert J. Klepinski, Regulatory Attorney, with Fredrikson & Byron and airs on Thursday, January 19th, 2012. For more details, or to register please visit our site at www.fxconferences.com
Most medical device companies today wish to gather data on product use and performance without being entangled in expensive IDE negotiations. However, recent FDA enforcement actions have brought new scrutiny to post-market studies. FDA has combined accusations of off-label promotion with enforcement against studies collecting data on usage deemed to be outside cleared labeling. So what are device manufacturers to do? Is there still a path available for collecting this important information? This audio conference explores the regulations involved, recent enforcement actions by FDA, the difficulties in ascertaining the scope of indications today, and ways to gather information within the current enforcement environment.
Most medical device companies today wish to gather data on product use and performance without being entangled in expensive IDE negotiations. However, recent FDA enforcement actions have brought new scrutiny to post-market studies. FDA has combined accusations of off-label promotion with enforcement against studies collecting data on usage deemed to be outside cleared labeling. So what are device manufacturers to do? Is there still a path available for collecting this important information? This audio conference explores the regulations involved, recent enforcement actions by FDA, the difficulties in ascertaining the scope of indications today, and ways to gather information within the current enforcement environment.
Wednesday, January 4, 2012
Voice of the Customer: The First Step in Human Factors Engineering
is being presented by Maria Shepherd, Principal, with Data Decision Group and airs on Tuesday, January 17th, 2012. For more details, or to register please visit our site at www.fxconferences.com
The medical device industry faces a unique challenge; R&D professionals develop products but rarely get a chance to use them, while quality departments lack the data to translate customer needs and marketing specifications into technical requirements and metrics. To compound the issue, FDA will soon have its final HFE Guidance in place, and all device products and companies will have to comply.
Voice of the Customer (VOC) allows device manufacturers to immerse product design teams in the customer’s culture and environment, and this audio conference presentation looks at how to use the VOC process to collect and analyze customer data and integrate it into the design process. Attendees learn how to develop market surveys and other tools to assess the needs of customers, and how to define and categorize customer issues with products. Our speaker discusses the relationship between VOC and HFE principles, and shares critical techniques for new product and product improvement initiatives.
The medical device industry faces a unique challenge; R&D professionals develop products but rarely get a chance to use them, while quality departments lack the data to translate customer needs and marketing specifications into technical requirements and metrics. To compound the issue, FDA will soon have its final HFE Guidance in place, and all device products and companies will have to comply.
Voice of the Customer (VOC) allows device manufacturers to immerse product design teams in the customer’s culture and environment, and this audio conference presentation looks at how to use the VOC process to collect and analyze customer data and integrate it into the design process. Attendees learn how to develop market surveys and other tools to assess the needs of customers, and how to define and categorize customer issues with products. Our speaker discusses the relationship between VOC and HFE principles, and shares critical techniques for new product and product improvement initiatives.
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