GlobalCompliancePanel to organize two-day seminar on “FDA and U.S. Customs Import Rules and Export Traps in 2020”

This plan seeks to reward importers who demonstrate a level of confidence about the quality of food they import by establishing an FDA-supervised, fee-based program.

GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, is organizing a two-day, in person, live seminar on the topic, “FDA and U.S. Customs Import Rules and Export Traps in 2020”, on December 4 and 5.

Casper Uldriks, an ex-FDA Expert and former Associate Center Director of CDRH, will be the Director of this seminar. Please enroll for this session by visiting https://www.globalcompliancepanel.com/seminar/tougher-import-rules-for-FDA-901966SEMINAR

————————————————————————————————————

Smarter, more sophisticated, more agile and more demanding. These are what the FDA and the Customs and Border Patrol Service (CBP) have become of late when it comes to their expectations and requirements from importing firms of the submission of information and adherence to government procedures. Firms that fail to properly execute an import and export program can expect the FDA and the CBP to delay, detain or refuse their shipments.

The new Automated Commercial Environment (ACE) computer program from the CBP has brought in many changes to the process of import logistics and information reporting for FDA regulated products. As a result, companies that do not comply with the requirements set out in the ACE program can experience one of the worst nightmares they can think of: having their shipment stopped before it is even loaded at the foreign port! And then, if they refuse to or fail to use the ACE program, such ships also carry a fine of up to $10,000 for every offense.

Embedded-Software-Development

There is more: such companies whose products the FDA detains face a cumbersome, long winding and expensive legal process. The FDA expects companies to have the import coding information accurate and up-to-date. Any company that lacks a thorough and clear understanding of the automated and human review process are almost certain to have their shipments detained.

And then, what happens in a scenario in which the FDA decides that importers should bring the products back to the port of entry after they received a release but cannot locate the product that has been sold? Well, in such instances, such companies are slapped a fine that is three times the value of the shipment, not to speak of the additional adverse legal concerns and strategies that come along.

What do all these mean? Simple: if you are an importer, you are doomed if you fail to comply with the FDA’s guidelines on imports.

Yet, there is a way out of this quagmire, in the form of the Voluntary Qualification Importer Program, which the FDA is implementing under the FDA Food Safety and Modernization Act. This plan seeks to reward importers who demonstrate a level of confidence about the quality of food they import by establishing an FDA-supervised, fee-based program. What this program does is that it facilitates the review and importation of foods from importers who establish a higher level of control over the safety and supply chain aspects of the imported food items.

And then, there is also the extra perk that the FDA offers: its export certificates. Offered at a reasonable fee; these certificates can go a long way in giving an importer a competitive advantage in foreign markets. In fact, a few foreign governments make an FDA export certificate a requirement.

————————————————————————————————————–

The aim of this seminar is to offer learning on all these core areas of the FDA and US Customs Import Rules in 2020. The Director will explain how to deal with common problems, such as returns for repair, importing QC samples, and investigational products. The learning will be taught over the following agenda:

Day 1 Schedule

Lecture 1:

FDA Legal Authority Customs and Border Control (CBP) Import Process FDA Import Process Registration and documentation

Lecture 2:

FDA Import Process (continued)

  • Import Brokers
  • Prior Notice Information
  • CBP and FDA computer programs
  • Import Codes
  • Bonds and Bonded Warehouses
  • FDA “Notice of Action”

Lecture 3:

Import Delays Import Alerts Detention Refusals

Day 2 Schedule

Lecture 1:

Foreign Inspections FDA 483 – Inspectional Observations

Lecture 2:

FDA Warning Letters and Automatic detention

Lecture 3:

Import Hypothetical FDA Import for Export Program FDA Export Program Export Hypothetical

Lecture 4:

FDA Export Program Special Import Issues

  • Trade Shows
  • Personal Use
  • Compassionate Use

—————————————————————————————————————–

https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm448728.htm

A guide to practical Risk Management – Applying ISO14971 and IEC62304

It will help to comply with regulatory requirements with minimized overhead and resource burden.

Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management.

To comprehensively summarize all risk related activities and to demonstrate the safe properties of a device the ‘Safety Case’ or ‘Assurance Case’ document is a well-established method to collect all safety related information together in one place. This documentation will most likely become mandatory for all devices (currently only required for FDA infusion pump submissions). This course will introduce the basic concepts and content of safety assurance cases and will illustrate the usefulness for internal and external review of safety related information.

The course will introduce the main elements of risk management with emphasis on the application of risk management principles and requirements to the medical device development cycle. Risk management has become the method of choice to ensure an effective and safety oriented device development. International consensus, reflected in globally applicable standard requirements, has led to risk management being a mandatory component of almost any activity in the medical device industry.

The course will emphasize the implementation of risk management into the development and maintenance process. It will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking. This seminar will address the system level issues of risk management as well as the increasingly important software and usability related issues of critical systems. It will help to comply with regulatory requirements with minimized overhead and resource burden. To make the combines effort to design, implement and verify a safe device transparent the concept of an assurance case will be introduced.

The course is mainly based on international consensus requirements such as ISO14971, IEC62366 and IEC62304. It will cover European (MDD), US (FDA) and international risk management requirements from a regulatory and practitioner’s perspective.

Following personnel will benefit from the course:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Project managers
  • Design engineers
  • Software engineers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Medical affairs
  • Legal Professionals

A guide to practical Risk Management [ISO14971 and IEC62304]

Risk management being a mandatory component of almost any activity in the medical device industry.

Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management.

management

To comprehensively summarize all risk related activities and to demonstrate the safe properties of a device the ‘Safety Case’ or ‘Assurance Case’ document is a well-established method to collect all safety related information together in one place. This documentation will most likely become mandatory for all devices (currently only required for FDA infusion pump submissions). This course will introduce the basic concepts and content of safety assurance cases and will illustrate the usefulness for internal and external review of safety related information.

Risk management with emphasis on the application of risk management principles and requirements to the medical device development cycle. Risk management has become the method of choice to ensure an effective and safety oriented device development. International consensus, reflected in globally applicable standard requirements, has led to risk management being a mandatory component of almost any activity in the medical device industry.

The course will emphasize the implementation of risk management into the development and maintenance process. It will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking. This seminar will address the system level issues of risk management as well as the increasingly important software and usability related issues of critical systems. It will help to comply with regulatory requirements with minimized overhead and resource burden. To make the combines effort to design, implement and verify a safe device transparent the concept of an assurance case will be introduced.

The course is mainly based on international consensus requirements such as ISO14971, IEC62366 and IEC62304. It will cover European (MDD), US (FDA) and international risk management requirements from a regulatory and practitioner’s perspective.

Following personnel will benefit from the course:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Project managers
  • Design engineers
  • Software engineers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Medical affairs
  • Legal Professionals

How to interpret and use more than just a standard tool-box

Metrology: QC Sampling Plans the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications.

How to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows:

  • ISO standards and FDA/MDD regulations regarding the use of statistics.
  • Basic vocabulary and concepts, including distributions such as binomial, hypergeometric, and Normal, and transformations into Normality.
  • Statistical Process Control
  • Statistical methods for Design Verification
  • Statistical methods for Product/Process Qualification
  • Metrology: QC Sampling Plans the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications
  • How to craft “statistically valid conclusion statements” (e.g., for reports)
  • Summary recommendations

The various statistical methods used to support such activities can be intimidating. If used incorrectly or inappropriately, statistical methods can result in new products being launched that should have been kept in R&D; or, conversely, new products not being launched that, if analyzed correctly, would have met all requirements. In QC, mistakenly chosen sample sizes and inappropriate statistical methods may result in purchased product being rejected that should have passed, and vice-versa.

This provides a practical approach to understanding how to interpret and use more than just a standard tool-box of statistical methods; topics include: Confidence intervals, t-tests, Normal K-tables, Normality tests, Confidence/reliability calculations, Reliability plotting (for extremely non-normal data), AQL sampling plans, Metrology (i.e., statistical analysis of measurement uncertainty ), and Statistical Process Control. Without a clear understanding and correct implementation of such methods, a company risks not only significantly increasing its complaint rates, scrap rates, and time-to-market, but also risks significantly reducing its product and service quality, its customer satisfaction levels, and its profit margins.

  • FDA, ISO 9001/13485, and MDD requirements related to statistical methods
  • How to apply statistical methods to manage product-related risks to patient, doctor, and the designing/manufacturing company
  • Design Control processes (verification, validation, risk management, design input)
  • QA/QC processes (sampling plans, monitoring of validated processes, setting of QC specifications, evaluation of measurement equipment)
  • Manufacturing processes (process validation, equipment qualification)

product-development-process-e1395175968927

  • QA/QC Supervisor
  • Process Engineer
  • Manufacturing Engineer
  • QC/QC Technician
  • Manufacturing Technician
  • R&D Engineer

Dont skip this with out reading fully

Risk Management in the Global Economy and outlook for 2017

Risk Management in the Global Economy and outlook for 2017.gif

Risk management in the global economy is a highly challenging field for risk managers from any part of the world. With most of the world’s countries almost becoming part of the global economy in this era of globalization; it is emerging that risks that apply to one part any one nation’s or group of nations’ economy could affect many more in a chain reaction, or domino effect.

The Judge Business School of Cambridge University, in its estimate for risk management in the global economy for 2017, has a rather bleak outlook for the global economy. The report analyzes that no fewer than 25 dozen of the world’s urban centers could face close to two dozen different kinds of major shocks of primarily an economic and also of a political and social nature.

risk-management-in-global-economy-and-outlookThis is going to likely impact these important nodal cities of the global economy to the extent that the world’s GDP is going to shrink by as much as 1.5% percent till 2019. This translates to something in the order of $ 1.2 trillion.

Factors determining risk management in the global economy in 2017The report pins down a few important factors that have contributed to the need for risk management in the global economy in 2017:

    • The world is producing more than it ever did in its history. This is because of the high level of human population, which is the highest ever recorded in history, and the economic, agricultural and industrial growth of many underdeveloped economies
    • There has been an unprecedented increase in crises and disruptions in the geopolitical, financial and technological fronts, making risk management in the global economy for 2017 an important area to be addressed by the political and financial leaders around the world

risk-management-in-global-economy-and-outlook

  • The financial sector has come under greater strain in the past few years following the slowdown of 2008 than it had in the few preceding ones, making the prospect of a global meltdown any time in the future a possibility, if not a certainty
  • Added to these, risk management in the global economy for 2017, like in any other year, does face prospects that are of a natural order, such as natural disasters and wars.
Global economy will bear the brunt

risk-management-in-global-economy-and-outlookAll these factors would not have had the same impact as they are likely to have in the current scenario and in the immediate and intermediate future, if not for globalization. The world’s shift towards globalization is now certain and irreversible. The interconnected nature of the global economy has ensured that a shock in one part of the global economy is sure to cause ripples of either a minor or major nature in any other part.

Other important factors for risk management in the global economy in 2017risk-management-in-global-economy-and-outlook

Click to Continue Reading

An understanding of Risk Management and Analysis for Medical Device Manufacturers

Risk Management and Analysis1.jpg

Risk management and analysis for medical device manufacturers is an essential set of approaches to quality in the field of medical devices. Implementing these is of absolute importance and criticality to the field, as the products in this industry are high-specialty ones that deal with human lives. A small error at any stage can send the product, and with it, the reputation of the manufacturer and even the healthcare provider, into a tailspin.

From its beginnings a few decades ago as a “nice to have” feature or discipline that used to come into the picture only when there were issues; quality has grown into an indispensable element of a medical device product. A medical device product into which quality does not get intertwined at every stage, right from procurement of the raw material to the use it is put to by the consumer and beyond, is unthinkable today.

risk-management-and-analysis-for-medical-device--manufacturersThe primary driver of this metamorphosis is risk management. Risk management and analysis for medical device manufacturers has been the lynchpin among the agents of change brought about into this field. Quality has evolved as a result of the change in the import regime in the US in the seventies, when products from around the world used to deluge the US market.

the consequences of this trade policy have led to the emergence of the creation of quality approaches such as Six Sigma and kaizen among many others, and global standards, of which ISO 14971 specifically relates to Quality Management Systems and methods for medical devices. Root Cause Analysis is at the root of each of these methodologies and standards.

So, what is risk management and analysis for medical device manufacturers?

risk-management-and-analysis-for-medical-device--manufacturersIn the context of medical devices, risk management and analysis for medical device manufacturers means applying a set of processes, policies, methods and practices into their manufacturing systems in alignment with respective and relevant standards as set out by global standards such as the ISO. The aim of these standards and practices is to analyze, assess, control and monitor risk. The ISO 14971 has been revised many times and each time this is done, the latest one becomes the extant version. This and other standards and practices prescribe steps and processes that need to be implemented at all stages of the product lifecycle.

The need for risk management and analysis for medical device manufacturersThe need for risk management and analysis for medical device manufacturers is simple: To ensure that the medical device meets quality requirements and is manufactured according to standards and specifications and methods prescribed in these standards. Standards such as ISO 13485, various Quality Systems Regulations (QSRs) such as 21 CFR 820 and a few European standards work in tandem with ISO 14971. The core purpose of requiring medical devices manufacturers to meet these requirements is to ensure that safety and quality are built into a medical device from start to finish.

The time at which to carry out risk management and analysis for medical device manufacturers

risk-management-and-analysis-for-medical-device--manufacturersRisk management and analysis for medical device manufacturers is to be carried throughout the lifecycle of the medical device. A set purpose is set out at each stage of the manufacturing process. For example, medical device manufacturers are required to identify and eliminate potential hazards at the initial stage using the concepts of product optimization, and use the principles of risk elimination at all the next stages, and to use the methods prescribed during a product recall.

The ways of carrying out risk management and analysis for medical device manufacturersThe ways by which risk management and analysis for medical device manufacturers are to be exercised form an important part of quality. The ISO 14971 standard is pretty flexible in this regard, allowing the manufacturer to adapt any existing standard or approach that he thinks is best suited for his organization.

Click to Continue Reading

Benefits of Risk Management in all Industries

Benefits of risk management in all industries3

The benefits of risk management can be felt across all industries. Risk management is a process that needs to be applied if the risks have to be mitigated and contained, if not fully eliminated. The benefits of risk management in all industries came into greater focus following the financial debacle of 2008.

Firstly, why does an organization need to implement risk management strategies? Simple: Risks can offset the potential benefits and convert them into drawbacks. The benefits of risk management in all industries always outweigh the drawbacks of non-implementation of risk management strategies. In addition to helping the upper management get a better idea of the state of affairs of the company, benefits of risk management in all industries also help to reduce the financial burden for the organization and to meet regulatory requirements.

benefits-of-risk-managementIt needs to be understood that risk management is a set of processes that need to be implemented extremely stringently and diligently at every possible stage. Risk management is a journey, not a destination. For the benefits of risk management in all industries to be felt thoroughly, it is important to understand that it is intuitive.

Each industry has its unique risksRisk management is not a standard set of processes or exercises that can be applied into every industry. For example, the benefits of risk management in the finance sector could be different from those of the manufacturing industry. Likewise, the benefits of risk management in all industries in the life sciences sector could be way different from the risk management that is implemented in say, human resources.

benefits-of-risk-managementYet, even though the dynamics of risk management are different across all industries and are unique to each of them; the benefits of risk management in all industries are there to be felt and experienced.

Look out for the sleeping monstersEven though risk management is implemented in accordance with its own set principles or standards; there is still a possibly that some risk that was not obvious at an earlier stage could spring an unpleasant surprise later. This makes the benefits of risk management in all industries all the more worthy of consideration.

If the benefits of risk management in all industries need to be felt; the most important quality for risk managers is to inculcate the ability to see what is called the “unknown unknowns”. In simple terms, this is a phase used to describe the ability to foresee beyond the known factors.

benefits-of-risk-management

The ability to see beyond the obviousA few factors could become manifest in clear ways, but it is the obscure and latent ones that need greater attention. It is not always possible for even the most farsighted business risk manager to sometimes grasp the dormant risks that could crop up out of nowhere and pose a threat to the business. Developing this ability helps to realize the full benefits of risk management in all industries, because this is a quality of risk management that is common across all industries.

benefits-of-risk-managementIn order to realize the benefits of risk management in all industries fully, risk managers need to be on their guard all the time. This is obvious and goes without saying, but in the light of the fact that some risks can become enormous and uncontrollable at later stages, it is best for risk managers to understand ways of deriving the benefits of risk management in all industries.

 

Click to Continue Reading