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. 

Getting overtime pay calculation wrong can be damaging for the employer

A thorough grasp of the subtleties of the Fair Labor Standards Act (FLSA) continues to elude many employers, even though this Act has been around for a long time. The frequent changes that keep happening to the many regulations of the FLSA from time to time are one of the major reasons for this. These changes have employers, employees and attorneys scrambling for the meaning, interpretation and application of the new regulations, resulting in a huge load of extremely expensive FLSA lawsuits under this legislation.

Most of these legal disputes arise because attorneys make impermissible deductions from wages. They don’t count all the hours an employee has worked in determining overtime due, or they get their calculations plain wrong.  An idea of the magnitude of the effects of this misunderstanding of the provisions of the FLSA by employers can be had from the fact that The Department of Labor (DoL), which is already operating on a budget of $311 billion; requested an additional $104.5 billion for its 2015 budget for discretionary and mandatory programs. All these point to a new vigor and zest in this department in cracking down on false calculations and other improprieties.

Learn the nuances of overtime pay

In order to clear the misunderstandings anyone may have about the various elements of this law; GlobalCompliancePanel, a well-known provider of professional trainings for the areas of regulatory compliance, will be organizing a two-day seminar. Susan Fahey Desmond, a principal with Jackson Lewis PC, who has been representing management in all areas of labor and employment law for over 30 years, will be the Director of this seminar. To enroll for this highly valuable learning session, please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900679SEMINAR?calculating-overtime-correctly-SFO-CA.

At this seminar, Susan will go through all of the nuances of the FLSA and will cover the most frequent mistakes employers make repeatedly. She will explain the employer/employee relationship under the FLSA in detail, and will offer a description of areas such as the exemptions and what time is compensable. Another important learning of this seminar is about ways by which employers can decrease their overtime liability.

Susan will cover the following areas at this seminar:

o   Understanding the employer/employee relationship under the FLSA

o   Analysis of independent contractor v. employee

o   Volunteers and trainees

o   Exemptions - managerial, administrative, professional, outside sales, specific industry exemptions, the Motor Carrier Act

o   What is Working Time with discussion of the Portal to Portal Act

o   New Requirements for Breastfeeding Mothers

o   Calculating Overtime Correctly - determining the workweek and calculations.

o   Using approved ways to reduce overtime liability - fluctuating workweek, Belo Plans, Union Employee Plans, compensatory time

o   Minimum Wage Requirements and handling of deductions like garnishments, employee theft, company equipment, etc.

o   Child Labor laws - when they can work, what they can do, what breaks are required

o   Recordkeeping Requirements 

The interconnectedness between human resources and project management

Although a superficial look may suggest nothing in common between HR and project management; upon scratching the surface a bit, one discovers a close relationship between the two. Project management and HR are very closely related to each other, if one considers the similarity in the approach to the two disciplines:

Project management is rooted in planning. A detailed, systematic, team-involved plan is at the core of successful project implementation. Therefore, the project leader who plans well succeeds in executing the project and taking it a notch higher. 

The ability to plan precisely is of equal importance for HR, because much of what progresses in the organization hinges on HR’s planning ability. When HR plans and implements properly and effectively, that is a sure prescription for the organization’s success and growth. Like project managers, HR is also expected to transform a vague concept into a measurable outcome by channeling a broad array of knowledge, skills, and resources toward a critical organizational goal.

A learning session on the link between HR and project management

A proper understanding of this link between HR and project planning is the learning that a two-day, in person seminar being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will be imparting.

The speaker at this session, Cathleen Hampton, a professional consultant with over 25 years of HR experience, will talk about strategic and effective management and implementation of programs and ways in which HR professionals can facilitate both of these in their organizations. To gain learning of the crucial link between HR and project management, just log on to

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900725.

Understanding the similarities

Over two days of learning, Cathleen will expose participants to the basic principles concerning the nuts and bolts of planning, scheduling, and budgeting. These will be the outcomes of this learning:

o   Strengthening of skills and understanding how to generate valuable benefits for the organization by achieving crucial results that align with organizational objectives

o   Knowledge of the communication skills it takes to get ideas, instructions, and requests across quickly and accurately, thereby minimizing development time

o   Effectively using resources to stay on top of deadlines and expenses

o   How to rebound quickly from surprises and setbacks

o   How to get the best from people who don't normally report to them

o   These are the objectives of this seminar:

o   Learning the imperative questions to ask before even beginning

o   How to use the planning and scheduling tools that professional project managers use, such as GANTT charts, the critical path method, work breakdown structures, project management software, and others

o   Best practices for team work

o   Understanding when and how the “Murphy factor” could hit the project and impact it in a big way.

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. 

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. 

Identifying and managing key risks is the primary purpose of HR auditing

Human resources audit should qualify as the most important of all audits of an organization. This is because HR auditing is directly related to employees, who are the organization’s most important resource. It is through an HR audit that an organization evaluates its employees’ strengths and weaknesses.

HR audits help organizations in a number of ways

HR auditing helps organizations in many ways. Through HR audits, organizations are able to ascertain potential and actual problem areas, assess the effectiveness of current HR management activities, measure the weaknesses in HR internal control processes, evaluate human capital strategic and compliance related risks, and suggest corrective action on all these.

Getting the HR auditing right

The fulcrum for all these for an organization is in getting its HR audit right. The ways by which this can be achieved will be the subject of a seminar that GlobalCompliancePanel, a renowned provider of professional trainings in the regulatory compliance areas, will be organizing. More on this teaching session can be had from

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900673SEMINAR?HR-auditing-identifying-Salt-Lake-City-UT.

 The Director at this seminar, Ronald Adler, who is President of Laurdan associates, Inc., will offer insights into HR auditing in a way only a person such as him, who has spent over four decades in the industry, can.

The basis of effective HR auditing lies in asking the right questions

Ronald Adler will emphasize the point that the root to carrying out HR audits effectively is in asking the right questions. The effectiveness of HR audits is measured by how they throw up a structured and systematic series of questions about the areas relating to key compliance, risk management, internal auditing, and human resource management issues in HR, which are the main purpose of these audits.

Key issues affecting HR audits in 2016

Because of the coming together of a variety of factors; HR auditing has taken a new role and importance from 2016. These factors include:

o   The increasing importance of human capital in the age of ever increasing globalization

o   The insufficiency of the present financial institutions to foresee and contain the outbreak of corporate scandals and bring about greater transparency in these institutions

o   The recognition by leading bodies and legislations such as the EEOC, the OFCCP, U.S. DOL, the NLRB, and ICE of the importance of HR audits as an effective tool for self-audits

The role of ERM in HR audits

Another important point that Ronald Adler will highlight at this seminar is the importance of HR audits in considering human capital-related risks and opportunities from an Enterprise Risk Management (ERM) perspective. This means that the HR audit should take a holistic view of human capital risks and align the interrelationships and interactions between HR and other functions relating to management and the organization.

Yet another aspect that will be reviewed is the current use of HR audits. Adler will explain how HR Audits can be used to help the organization reduce risks and grab potential opportunities.

Contact Information:

http://www.globalcompliancepanel.com/ 

+1-800-447-9407