Risk Management in the Global Economy and outlook for 2017

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.
This 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

• 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 All 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 2017

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Getting design controls right is absolutely essential for medical device companies

Design Controls are absolutely essential for ensuring the safe and effective production of medical devices. The FDA too considers design Controls a critical process. Yet, design controls are among the most frequently cited areas for 483 and Warning Letter observations from the FDA. Although intrinsic quality, safety, and effectiveness of a device are known to be established during the design phase; a significant percentage of all medical device recalls are due to design problems, as statistics show.

The implications of poor design of medical devices controls are quite obvious:

o   They account for a significant number of recalls

o   Design issues can result in complaints and medical device reports

o   Design issues can even create manufacturability issues such as low yields and excessive scrap and rework, for companies.

Get an understanding of the solutions and the ways of implementing them

So, the solution to this problem is to find and fix issues early on in the design process. This is a much more effective and inexpensive alternative to fixing problems for products already in production.

The ways of ensuring a trouble-free design control process will be taught at a seminar being organized by GlobalCompliancePanel, a highly regarded provider of professional trainings for the regulatory compliance areas.

The Director at this seminar is Susanne Manz, an accomplished leader in the medical device industry, who emphasizes quality, compliance, and Six Sigma and brings extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. Please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900629SEMINAR to enroll for this seminar.

A valuable all-round learning session

Susanne will help participants understand and develop design controls processes and tools that are compliant with the regulatory requirements and are a competitive strength for their organizations. She will help them learn from past issues and improve their next generations of product.

She will help participants understand the requirements for design controls and how to translate them into an efficient and effective process for their organizations. She will start with the history and requirements for design controls. She will then move on to a discussion of the requirements and tools in detail. This seminar will include exercises to help participants practice and improve their design control process.

The following areas will be covered at this seminar:

o   Expectations

o   Regulations

o   Process

o   Lessons Learned

o   Myths

o   Challenges

o   Best Practices

o   Inspection Readiness.

Comprehensive risk management is a must for medical device software

Diligent, complete and correct implementation of risk management of software used in medical devices that takes into consideration the gaps and corrects them from the start of product development is absolutely imperative. This is because of two critical reasons:

    1.      Gaps, incorrect or incomplete implementation can retard or delay or make the certification/approval of medical products impossible;

    2.      Since most activities are closely linked to the development lifecycle; almost none of it can be retrospectively performed. This renders all activities performed till the identification of gaps useless and redundant; making it necessary to start from the beginning, no matter at what stage an anomaly is discovered.

Embedding software risk management into the bigger scope of overall risk management is the way forward if these fiascos have to be avoided.

Learn the ways of doing it right from start till finish 

The proper ways of how to take all the necessary steps for designing, implementing and testing critical medical device software in a regulatory compliant environment will be the learning a two-day, live seminar being organized by GlobalCompliancePanel, a very respected provider of professional trainings for the regulatory compliance areas will impart.

Markus Weber, Principal Consultant with System Safety, Inc., who specializes in safety engineering and risk management for critical medical devices, will be the course Director. To participate in this very important seminar, please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900683SEMINAR.

In line with globally applicable standard requirements

International consensus, reflected in globally applicable standard requirements such as ISO14971 and IEC62304, has led to risk management being a mandatory component of almost any activity in the medical device industry. This course will explain these requirements.

Given that software risk management has to be embedded into the bigger scope of overall risk management; Markus will introduce all the steps necessary to design, implement and test critical medical device software in a regulatory compliant environment while adhering to the principles of risk management. In addition, he will also address the system level risk management and the resulting interfaces to software.

Understanding safety assurance cases

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

This seminar will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking. It will address the system level issues of risk management as well as the increasingly important software related issues of critical systems. The concept of an assurance case will be introduced to make the combined effort towards designing, implementing and verifying a safe device transparent. The outcome of this learning is that it will help to comply with regulatory requirements with minimized overhead and resource burden.

      

Applied Statistics for product and process evaluation in design and manufacturing

Evaluating product and processes is an imperative for almost all design and/or manufacturing companies. These are the reasons for which this evaluation needs to be made:

o   Managing risks

o   Validation of processes

o   Establishing product/process specifications to QC to such specifications

o   Monitoring compliance to such specifications

Lack of proper and thorough grasp of and correct implementation of statistical methods leads a company to having to face significant increases in its complaint rates, scrap rates, and time-to-market. As a result, such companies churn out poor quality in their products, leading to lowered customer satisfaction levels, severely impacting their bottom line.

A learning session to help understand statistical methods

In order to help professionals in process and manufacturing meet challenges associated with statistical methods with greater confidence, GlobalCompliancePanel, a highly reputable provider of professional trainings for the regulatory compliance areas, is organizing a highly educative two-day seminar on the topic, “Applied Statistics, with Emphasis on Verification, Validation, and Risk Management, in R&D, Manufacturing, and QA/QC”.

John N. Zorich, Statistical Consultant & Trainer, Ohlone College & SV Polytechnic, will be the Director at this seminar, which has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

To enroll for this seminar, participants can log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900537SEMINAR.

Hands on approach to statistical methods toolbox

The aim of this seminar is to offer a hands-on approach by which the participants could comprehend the ways to interpret and use a standard tool-box of statistical methods that consist of confidence intervals, t-tests, Normal K-tables, Normality tests, confidence/reliability calculations, AQL sampling plans, measurement equipment analysis, and Statistical Process Control.

The Director will equip the seminar delegates with clarity on how to accurately employ and administer statistical methods, which can be used as a launchpad for introducing new products. 

This two-day session will help participants understand the proper way of avoiding issues relating to these aspects of statistical methods. John will explain how to apply statistics to manage risk in R&D, QA/QC, and Manufacturing by giving real life examples derived mainly from the medical device design/manufacturing industry.

John will cover the following areas at this seminar:

• 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).

Comprehensive risk management is a must for medical device software

Diligent, complete and correct implementation of risk management of software used in medical devices that takes into consideration the gaps and corrects them from the start of product development is absolutely imperative. This is because of two critical reasons:

    1.      Gaps, incorrect or incomplete implementation can retard or delay or make the certification/approval of medical products impossible;

    2.      Since most activities are closely linked to the development lifecycle; almost none of it can be retrospectively performed. This renders all activities performed till the identification of gaps useless and redundant; making it necessary to start from the beginning, no matter at what stage an anomaly is discovered.

Embedding software risk management into the bigger scope of overall risk management is the way forward if these fiascos have to be avoided.

Learn the ways of doing it right from start till finish

The proper ways of how to take all the necessary steps for designing, implementing and testing critical medical device software in a regulatory compliant environment will be the learning a two-day, live seminar being organized by GlobalCompliancePanel, a very respected provider of professional trainings for the regulatory compliance areas.

Markus Weber, Principal Consultant with System Safety, Inc., who specializes in safety engineering and risk management for critical medical devices, will be the course Director. To participate in this very important seminar, please log on to

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900681SEMINAR?risk-management-medical-devices-Boston-MA.

In line with globally applicable standard requirements

International consensus, reflected in globally applicable standard requirements such as ISO14971 and IEC62304, has led to risk management being a mandatory component of almost any activity in the medical device industry. This course will explain these requirements.

Given that software risk management has to be embedded into the bigger scope of overall risk management; Markus will introduce all the steps necessary to design, implement and test critical medical device software in a regulatory compliant environment while adhering to the principles of risk management. In addition, he will also address the system level risk management and the resulting interfaces to software.

Understanding safety assurance cases

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

This seminar will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking. It will address the system level issues of risk management as well as the increasingly important software related issues of critical systems. The concept of an assurance case will be introduced to make the combined effort towards designing, implementing and verifying a safe device transparent. The outcome of this learning is that it will help to comply with regulatory requirements with minimized overhead and resource burden. 

Preparing for an ISO 13485 audit

Being the current standard for medical devices; the ISO 13485 prescribes a set of standards that are to be implemented by manufacturers of medical devices. The aim of ISO 13485 is to ensure that medical devices meet the prescribed quality standards. This standard was conceived with the intention of making medical device manufacturers understand ways by which to establish a medical device risk management process.

Implementation needs proper training

Implementation of the ISO 13485 needs expert knowledge. Medical device organizations that need to implement it need to have trained staff, which needs to be aware of what to do when they are approached by an auditor. They should also know what documentation must be completed, kept up-to-date, and be made available, so that the organization can avoid major and minor findings. In addition, they should also be thoroughly aware of the issues that auditors constantly look for. They need to also be knowledgeable about the new updated standard.

Get trained on how to prepare

To make medical device professionals that face an ISO audit familiar with the dynamics of an ISO audit and to acquaint them with what it takes to be prepared for one when it happens, GlobalCompliancePanel, a globally known provider of professional trainings for the areas of regulatory compliance, will be organizing a two-day, in person seminar.

To enroll for this seminar and to get a thorough understanding of the ways by which to implement ISO 13485, just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900708.

The Director at this seminar, Jason Teliszczak, who is CEO/Founder, JT Environmental Consulting, will give a complete understanding of how to prepare for an ISO audit in a manner that helps organizations defend their actions with the auditors and to avoid a number of errors and goof-ups that could result in harsh actions. In taking a detailed look at each section of the standard; Jason will let participants understand the core elements of an ISO audit.

He will offer real world examples of what to expect, and what to prepare and repeal within the audit guidelines, the ways of ensuring a compliant documentation system, infrastructure maintenance, PPE, ensuring quality by the judicious use of materials, ways of choosing suppliers and vendors, ways of going about an internal audit, and the role of management in certification. 

Verification vs validation is a key understanding for regulatory professionals

For regulatory professionals, aspects of verification and validation, such as how to get verification and validation right, and an understanding of the ways in which verification and validation diverge from each other and converge, make up very important learning. The key point is that verification and validation should be risk based and be built keeping in mind the extant regulatory expectations.

Building a verification and validation process that sufficiently uses targeted and documented risk based verification and validation test case elements or scripts is the foundation to this. All these have to be reviewed against ISO 14971 and ICH Q 9 hazard analysis and product risk management.

Getting their V & V right involves gaining and exercising proper knowledge of these areas on the part of professionals working in regulatory environments. This learning is what a two-day seminar by GlobalCompliancePanel, a very well-known provider of professional trainings for all the areas of regulatory compliance, will impart.

V & V against the regulatory process

The Director of this seminar, John E Lincoln, a senior Consultant for Medical device and Regulatory Affairs, will explain the rationale behind verification and validation and clear all the ambiguities relating to this activity.

He will help participants to understand the following:

o   Evaluating different field-tested, U.S. FDA-reviewed V&V protocols

o   Ways by which to employ equipment/process Requirements Specs/DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500. John E Lincoln will help participants how to do all these against a background of limited company resources

o   Reviewing a matrix that simplifies “as-product”, “in-product”, process and equipment and related matters

o   Software VT&V to ensure that key FDA requirements are not overlooked

To enroll for this course, just log on to

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900645SEMINAR?verification-vs-validation-qms-Las-Vegas.

The Director will also offer hands-on understanding of Quality Management Systems and 21 CFR Part 11. This seminar will help participants:

o   Understand Verification and Validation, differences and how they work together;

o   Discuss recent regulatory expectations;

o   Know how to document a "risk-based" rationale, and use it in a resource-constrained environment;

o   Determine key "milestones" and "tasks" in a project;

o   Locate and document key subject "inputs";

o   Compile "generic" Master and Individual Validation Plans;

o   Learn the key element of a Product V&V File/Protocol;

o   Understand how to develop Process and/or Production/Test Equipment V&V Files/Protocols;

o   Get a grasp of basic Test Case construction;

o   Understand sample sizes and their justification;

o   Learn the key elements of Software V&V expected by the FDA and how to document;

o   Deal with hardware and software vendors, sales and marketing

o   Consider a field-tested software V&V documentation "model";

o   See how to compile QMS Electronic Records and Electronic Signatures V&Vs to satisfy 21 CFR Part 11.

Get your HIPAA compliance right in six simple steps

The most important element that Covered Entities and Business Associates must keep in mind while carrying out HIPAA audits is best summarized in the words of Jocelyn Samuels, the top Federal official in charge of HIPAA enforcement. To quote her own words, Covered Entities and Business Associates must ensure compliance through “... a comprehensive and thorough approach to assessing and addressing the risks to all of the Protected Health Information (PHI) they maintain”.

Although Risk Analysis is mandatory; HIPAA audits of 2012 showed that as many as four fifths of health care providers failed to comply with this mandatory requirement. Covered Entities and Business Associates are under severe pressure to do a HIPAA Risk Analysis of all the PHI’s they maintain. Most of this, they are expected to do on their own. This explains perhaps just why 80% of health care providers failed to do the Risk Analysis, a fact discovered by the HHS. In fact, the incidence of HIPAA violations has been increasing so steeply that 2015 was sardonically referred to in HIPAA circles as the “Year of the Breach”. This fact leads to the next important point: higher and greater number of government enforcement and private lawsuits.

Learn the ways of getting HIPAA compliance right in just six simple steps

The above facts make it absolutely imperative for Covered Entities and Business Associates to get every aspect of the HIPAA compliance right, in the manner suggested by Jocelyn Samuels. This is precisely what GlobalCompliancePanel, a highly renowned provider of professional trainings for all areas of regulatory compliance, will be imparting at a two-day, in person seminar. To enroll for his event, just visit

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900616SEMINAR?master-HIPAA-compliance-six-steps-San-Diego.

The Director of this highly meaningful and valuable seminar is the well-known expert on HIPAA compliance, Paul Hales. Paul’s credentials get augmented by the fact that he has, with a team of expert advisors and practical field testers, created a method of making all HIPAA regulations accessible to the everyday person. Paul’s method explains all the aspects of HIPAA in uncomplicated and simple language and carries the exact citations to each regulation. This method is directed at organizations’ legal counsel who may not be well versed or experienced in HIPAA, and will be a major part of this seminar. 

Major benefits by learning from the expert

Organizations that are required to carry out HIPAA audits will gain enormously from this seminar. It will help them to save money, time, and research. Paul will discuss how Business Associates and Covered Entities can grow their practice and be compliant. His method will serve as the very foundation on which organization can implement their HIPAA Compliance Program. Most importantly, he will teach how they can grow what is most valuable to their business: Their patients. Paul’s HIPAA compliance method, which consists of six easy steps, will create a level of quality to the advice that the legal counsel provides.

He will take participants of this seminar through a Risk Analysis for their organization and will also delve into the Privacy, Breach, and Security Rules as applicable to their particular organization. 

Handle internal investigations thoroughly, else employees could approach law agencies

Employees have a right to approach external sources such as the Equal Employment Opportunity Commission (EEOC), the National Labor Relations Board (NLRB), Wage and Hour, private attorneys, and juries against the employers, when feel that their legitimate complaints are not being heard by their employers.

But first, a clear definition has to be made of what constitutes legitimate complaints and a distinction has to be made between legitimate and unsubstantiated complaints. This is because employers are legally empowered and obliged to carry out certain kinds of investigation, namely the kind done on what the law considers as a legitimate employee complaint, and not others. It is thus important for employers to have a thorough understanding of what type of complaint is considered by the law as legitimate and what is not.

Follow the procedures to be safe at investigations

This distinction determines whether the employee will go to any of the external agencies mentioned above to complain against the employer or not. Further, quick and sound action that is legally compliant will also help juries or other agencies decide whether or not the employers took quick and appropriate action to address legitimate employee complaints. Following the right procedures will help to protect the organization against such complaints, if the juridical sources find that the employer took the right action on time to redress the employee’s legitimate complaint.

HR has to be quick and has to think on its feet if it is to avoid giving the employee the opportunity to approach an external agency, the fallout of which can be potentially damaging. In order to help HR professionals understand the way by which to carry out a legally tenable and fair investigation of the complaints; GlobalCompliancePanel, a leading global provider of professional trainings in all areas of regulatory compliance, will organize a two-day seminar.

To enroll for this seminar, please log on to

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900677SEMINAR?conducting-internal-investigations-San-Diego-CA.

Susan Fahey Desmond, a principal with Jackson Lewis PC and noted author and speaker, will be the Director of this seminar.  Susan will offer a thorough understanding of how to classify a complaint by the employee as a legitimate one. Lack of this knowledge on the part of the organization’s HR will result in having to battle it out in court. 

Applied Statistics for product and process evaluation in design and manufacturing

Evaluating product and processes is an imperative for almost all design and/or manufacturing companies. These are the reasons for which this evaluation needs to be made:

o   Managing risks

o   Validation of processes

o   Establishing product/process specifications to QC to such specifications

o   Monitoring compliance to such specifications

Lack of proper and thorough grasp of and correct implementation of statistical methods leads a company to having to face significant increases in its complaint rates, scrap rates, and time-to-market. As a result, such companies churn out poor quality in their products, leading to lowered customer satisfaction levels, severely impacting their bottom line.

A learning session to help understand statistical methods

In order to help professionals in process and manufacturing meet challenges associated with statistical methods with greater confidence, GlobalCompliancePanel, a highly reputable provider of professional trainings for the regulatory compliance areas, is organizing a highly educative two-day seminar on the topic, “Applied Statistics, with Emphasis on Verification, Validation, and Risk Management, in R&D, Manufacturing, and QA/QC”.

John N. Zorich, Statistical Consultant & Trainer, Ohlone College & SV Polytechnic, will be the Director at this seminar, which has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

To enroll for this seminar, participants can log on to

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900535SEMINAR?applied-statistics-QA-QC-Seattle-Washington.

Hands on approach to statistical methods toolbox

The aim of this seminar is to offer a hands-on approach by which the participants could comprehend the ways to interpret and use a standard tool-box of statistical methods that consist of confidence intervals, t-tests, Normal K-tables, Normality tests, confidence/reliability calculations, AQL sampling plans, measurement equipment analysis, and Statistical Process Control.

The Director will equip the seminar delegates with clarity on how to accurately employ and administer statistical methods, which can be used as a launchpad for introducing new products. 

This two-day session will help participants understand the proper way of avoiding issues relating to these aspects of statistical methods. John will explain how to apply statistics to manage risk in R&D, QA/QC, and Manufacturing by giving real life examples derived mainly from the medical device design/manufacturing industry.