Understanding the practical application of statistics?

The application of statistical methods is specified all through 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries for these activities:

o  Setting validation criteria and specifications

o  Performing Measurement Systems Analysis (MSA)

o  Conducting stability analysis

o  Using Design of Experiment (DOE) for process development and validation

o  Developing process control charts

o  Determining process capability indices.

The Quality System Regulation (QSR) for medical devices states that manufacturers should take steps, where appropriate, for establishing and maintaining procedures with which to identify valid statistical techniques needed to establish, control, and verify that the process capability and product characteristics are acceptable.

Methods are specified in 21 CFR and guidance documents

Both 21 CFR and guidance documents emphasize the need for statistical methods from discovery through product discontinuation. While 21 CFR specifies the suitable statistical procedures needed to establish both in-process and final specifications; the guidance documents require applying statistical methods for development and validation of measurement systems, process understanding using Quality by Design (QbD) principles, process validation, as well as ensuring that the manufacturing process is in a state of control and is capable.

Even though many statistical methods may be applied to fulfil this part of the QSR; there exist a few commonly accepted methods that all companies can and preferably should use for:

o  Developing acceptance criteria

o  Ensuring accurate and precise measurement systems

o  Fully characterizing manufacturing processes

o  Monitoring and controlling process results, and

o  Selecting an appropriate number of samples.

Learn the dynamics of statistical methods

The nitty gritty of application of statistical methods will be the teaching a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will be offering. At this seminar, Heath Rushing, who is the cofounder of Adsurgo and author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP; will be the Director.

This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion. To understand the areas of implementation of statistical methods that comply with the requirements set out in CFR 21 and guidance documents, please enroll for this session by visiting “Understanding the practical application of statistics”

A full description of statistical processes

This course provides instruction on the statistical methods for data analysis of applications related to the pharmaceutical, biopharmaceutical, and medical device industries. The Director will explain the appropriate statistical approaches: descriptive statistics, data intervals, hypothesis testing, ANOVA, regression, ANCOVA, and model building need to be applied. Upon establishment of competence in each of these areas; he will present the way these need to be applied in an industry-specific manner.

During the course of these two days, Heath will cover the following areas:

·        Describe and analyze the distribution of data

·        Develop summary statistics

·        Generate and analyze statistical intervals and hypothesis tests to make data-driven decisions

·        Describe the relationship between and among two or more factors or responses

·        Understand issues related to sampling and calculate appropriate sample sizes

·        Use statistical intervals to setting specifications/develop acceptance criteria

·        Use Measurement Systems Analysis (MSA) to estimate variance associated with: repeatability, intermediate precision, and reproducibility

·        Ensure your process is in (statistical) control and capable.

Knowledge of employment laws is absolutely crucial for organizations

As the new presidential administration settles in in the US, employment law could be an area in which to expect tremendous changes. While what the new president’s open and vocal support for protection of the domestic workforce will mean to employment laws may take some to fully unfold and unravel; a look at the evolution of the important employment laws and the changes taking place into them of late should serve as some kind of indication of what is to come.

One thing that is certain is that 2017 is going to be an uncertain year for employment law. Changes that could make a big difference to many organizations can be expected to be rolled out by the new administration. A fact of additional significance to employers is that there has been a steady increase in the number of employment lawsuits of late.

In 2016, enforcement actions by the Equal Employment Opportunity Commission (EEOC) gave the agency a staggering amount of between $350 and $400 million in monetary damages. This has been the highest recovery ever from the time it was created in 1965. Not surprisingly, the number of claims filed by employees with this Commission has reached record levels in the last three years.

Lack of knowledge of the law is at the root of lawsuits

Most of these lawsuits are a result of the lack of understanding that employers have of workplace issues. Companies in which the managements are ignorant about these issues or choose to overlook them end up facing a host of issues such as:

o  Discrimination suits

o  Employee turnover

o  Unplanned expenses

o  Settlements

o  Litigation

o  Lawyer fees

o  Low morale on the part of employees

o  A bad beating to their image.

The means to avoiding such scenarios is for organizations to grasp the enormity of these actions. If they have to avoid litigation and other reputation-damaging actions; they need to be aware of the employment law regulations and be compliant with these. They also need to be clear in their understanding of what to expect from the new administration.

A session to help get thorough understanding of employment laws

It is to impart understanding of these topics that a GlobalCompliancePanel, a leading global name in the field of regulatory compliance trainings, will be organizing a two-day seminar. Vanessa G. Nelson, who is founder and President of award-winning Expert Human Resources, which she founded to help companies maintain employment law compliance, avoid workplace litigation, maximize human capital, create great teams, and reduce costs, will be the Director of this course.

To get complete understanding of all the crucial aspects of human resource law, the ways by which to comply with employment laws and regulations and the potential impact on employment law from the actions of the new administration; please register for this seminar by visiting Knowledge of employment laws is absolutely crucial for organizations .

A clear roadmap to advanced human resources and employment law

The essence of this seminar is the roadmap to advanced human resources and employment law that Vanessa will lay out for the participants. Given the factors described above; this understanding is critical, no matter what the size of the organization. The right grasp of employment laws and HR practices is essential if organizations have to become successful at their business. The Director of this seminar will simplify the complex nature and the huge number and variety of employment laws and the issues relating to them.

Participants will able to learn the ways of dealing with often muddling human resource situations and how to apply relevant employment laws correctly to avoid problems. A look at the cost of litigation will perhaps give some idea about the need for employers to remain compliant with the employment laws: Without lawyer fees, a lawsuit costs $165,000 on average. The cost of a case that goes to trial is exorbitant: It is in excess of a million dollars, and comes with the strong prospect of imprisonment for noncompliance with employment.

Marketing and promotion of drugs and medical devices

Regulation of the promotional aspects of prescription drugs, biologics, medical devices and biotechnology products with the intention of ensuring that the information contained in the promotion material is not false or misleading is one of the chief objectives of the FDA.

The FDA regulates the promotional materials of all drugs, and this includes both labeling and advertisements. Brochures, booklets, detailing pieces, bulletins, calendars, motion pictures and slides are some of the examples of labeling, while materials published in journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television and telephone communications systems are examples of advertising.

The FDA also regulates another avenue of drug promotion and advertising, namely detailing. This kind of promotion is the one that pharma companies do to doctors in a variety of venues such as medical offices, hospitals, pharmacies, at medical meetings and symposia, academic settings, conferences and other meeting facilities.

The FDA’s reach in monitoring and regulating promotions also covers direct-to-consumer (DTC) prescription drug advertising. In this area, it has complete jurisdiction over prescription drug labeling and advertising and all medical device labeling, but has limited jurisdiction over medical device advertising.

Severe penalties for offenders

For decades, the FDA has been regulating traditional advertising, during the course of which it has been publishing several kinds of guidance documents for industry, and has issued many violation letters. The corrective actions that companies have to implement if the FDA adjudges that drug or medical device promotional material is false or misleading or does not give a proper account of the product needed to enable consumers to weigh the benefits and risks are very expensive and time consuming. They have to carry out expensive remedial advertising, have to cough up huge fines, and also face the prospect of having their reputation sullied on account of these enforcement actions from the FDA.

In addition, it can also criminally prosecute relevant executives of such organizations under the provisions of a strict liability standard. This law gives the government sweeping powers, by which it is not obliged or required to show that the executive facing prosecution had the intention of violating FDA regulations or was knowledgeable about such violations.

The agency has already netted billions of dollars in fines, forfeitures and disgorgements from drug companies for the alleged marketing of a product for unapproved, or “off-label,” uses.

Are the FDA’s laws obsolete?

Yet, the general consensus is that the law governing drug and device marketing is both outmoded and insufficient to deal with the speed at which technology-enabled promotion campaigns appear out of nowhere and disappear in a jiffy. Experts feel that the FDA is still very conservative and traditional in adapting technologies needed for detecting and nailing down such promotion campaigns that technology has brought about. Naturally, the regulatory circles are eager to see how the FDA will deal with the advanced communication technology that goes into promotion campaigns that can make the advertisement go viral and leave the scene just as quickly.

These are important aspects for organizations in the drugs, biologics, medical devices and biotechnology areas. These companies need to be completely aware of the law governing advertising and need to understand the FDA’s thinking on what it considers false and misleading advertising. This knowledge is absolutely essential, considering the broad sweep of powers that the FDA has.

Important learning on the FDA’s approach to promotions and advertising

This important understanding will be imparted at a two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance. At this seminar, David R. Dills, Global Regulatory Affairs and Compliance Consultant, who provides regulatory affairs and compliance consultative services, will be the Director. To gain insights into the FDA’s thinking on how it perceives advertisements and promotions as false and misleading, please register for this seminar by visiting Marketing and promotion of drugs and medical devices. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Advertising aimed at healthcare professionals and consumers

Prescription drug promotion is aimed at and delivered to two distinct audiences: Health care professionals (HCPs) and consumers. The FDA recognizes that promotional efforts can provide these audiences important information about the newest developments in drug therapies. So, it insists that such information has to have integrity and completeness.

Also, healthcare professionals, sales representatives and consumers use the social media to discuss the use of prescription products for specific diseases and conditions, a factor that has to be taken into account. David will discuss this and the potential concerns it carries.

GlobalCompliancePanel Seminar Sponsorships

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Then, sponsoring GlobalCompliancePanel seminars is the answer. GlobalCompliancePanel is an accomplished provider of professional trainings for all the areas of regulatory compliance. It organizes two-day long seminars around the globe on all the topics relating to these areas. At these seminars, you can expect to see a highly distinguished collection of names that ring a bell in these industries. Read More

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Key issues in HR auditing

Key issues in HR auditing

The importance of HR auditing can be gauged from the fact that it is about employees, an organization’s most valuable resource. It is through HR audits that an organization evaluates its strengths and weaknesses of its most important resource. HR audits have come a long way from the earlier times, when they were considered a set of checklists to be ticked. Today, HR audits in organizations consist of a whole gamut of sustainable and continuous audit activities that relate to critical areas such as governance, compliance and management in the organization.

Important benefits of HR auditing

HR auditing helps organizations:

o  Zero in on not only existing problems relating to HR, but also potential ones

o  Assess the efficacy of HR management practices

o  Understand the deficiencies of the HR internal control processes

o  Evaluate human capital and risks, both from the strategic and compliance-related perspectives

Rightly done HR audits enhance the value of an organization’s human capital and its competitiveness and bring down its susceptibility to employment practices liabilities by advising the management on what corrective steps it needs to take to resolve HR internal control processes.

Most importantly, HR audits should take human capital related risks and opportunities from the standpoint of Enterprise Risk Management (ERM), which leads to higher interaction between HR and management.

Proper ways of carrying out HR auditing

Although most organizations understand the importance of HR auditing and its uses; it is important for them to get the exact ways of implementing it. Getting their HR auditing right is the stepping stone to many important useful and corrective steps.

Risk management is the single most important ingredient that has to go into HR auditing. The proper ways of carrying out HR auditing will be imparted at a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance.

The Director of this seminar is Ronald Adler, a president-CEO of Laurdan Associates, Inc., a veteran owned, human resource management consulting firm that specializes in HR audits, employment practices liability risk management, HR metrics and benchmarking, strategic HR-business issues and unemployment insurance. Ronald brings vast and deep experience in all the areas of HR including HR auditing.

Professionals who wish to benefit from this learning can register for this seminar by logging on to Key issues in HR auditing .

The Director of this seminar will help organizations direct and focus their attention on their human resource management practices, policies, procedures, processes, and outcomes.

Asking the right questions

The foundation to sound HR auditing is to ask the right questions. Sharp, thoughtful, perceptive and insightful, they should prod management into getting into the depths of HR auditing. The ways by which to ingrain the habit of asking the right, meaningful questions will be the major learning this seminar will impart. Ronald will show the ways by which HR auditing needs to learn to throw up a structured and systematic series of questions about core areas such as key compliance, risk management, internal auditing, and human resource management issues to HR, which after all, is the real purpose of HR audits.

An understanding of how to ask these questions should be out of the realization that no two employees that HR auditing policies are focused on are alike. This way, Ronald will give clarity on the distinguishing nature of HR auditing.

HR auditing from the ERM perspective

A core aspect of HR auditing is that it should be inseparably linked to Enterprise Risk Management (ERM) for it to become effective and successful. To make this happen, HR auditing should take a broader and comprehensive view of human capital risks bring the interrelationships and interactions between HR and other functions relating to management and the organization in alignment with each other.

Ronald will explain these, as well as the ways by which HR auditing can help the organization identify and capitalize on potential opportunities and reduce risks.

HR professionals and others related to HR auditing, such as CFO’s, Internal Auditors, External Auditors, Risk Managers, Compliance Officers and COOs can benefit from the lessons learnt at this seminar.

He will cover the following areas at this seminar:

o  Review an overview of employment related risk management and HR Audits

o  Assess human capital risks

o  Develop HR metrics

o  Explore the HR audit model

o  Assess strategic alignment

o  Assess HR management related documents

o  Assess HR management processes and practices

o  Review the practical applications of HR audits.

HIPAA’s compliance expectations from Business Associate

 

The Health Information Portability and Accountability Act (HIPAA) regards the Business Associate as a major player. HIPAA defines the Business Associate (BA) as either an organization or a person who works with or provides service to a Covered Entity, who in turn is defined as one who handles or discloses Protected Health Information (PHI).

So, a Business Associate is any person or entity that is involved in creating, receiving, maintaining or transmitting PHI to a Covered Entity for a purpose or activity or function as mandated and regulated by the HIPAA Privacy Rule.

Getting compliance right is complicated

While there is no ambiguity about the definition of a Business Associate; what is vague and confusing is the set of roles, responsibilities and requirements expected from a BA. HIPAA has a lot of expectations from the Business Associate. It expects total and complete compliance with the requirements it has set out for Business Associates.

The HITECH Act has recently made changes and updates, raising the bar of expectations from Business Associates. The reasoning for these changes is that the role of the Business Associate is critical, and its functions need to keep changing from time to time to accommodate the changes in technology, best practices, etc. As a result, it has extremely stringent mandates regarding the way a Business Associate handles and uses health information, which is confidential and highly valuable.

Compliance is not negotiable

A Business Associate has to show compliance with a wide range of regulatory requirements. The core areas of HIPAA compliance, such as privacy obligations, security standards, and breach notification requirements, are all where the Business Associate’s work is heavily regulated. A small deviation is viewed very seriously by the OCR. Punitive actions from the OCR are damaging to the Business Associate. The only way of avoiding these penal actions is to be completely compliant with the HIPAA expectations.

All these do not mean that Business Associates should dread HIPAA compliance implementation. They can become successful at their business if they get a complete grasp of HIPAA’s compliance requirements. They need clarity on a number of areas. Once their problem areas are addressed, they are sure to become successful in their business.

Come and get complete understanding of HIPAA compliance for Business Associates

It is with the aim of imparting this understanding that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a two-day seminar. Jay Hodes, who is a leading expert in HIPAA compliance and President of Colington Consulting, which provides HIPAA consulting services for healthcare providers and Business Associates, will be the Director of this seminar.

In order to get a complete grasp of the compliance requirements that HIPAA has for Business Associates, please register for this highly valuable seminar by logging on to HIPAA’s compliance expectations from Business Associate.

Total understanding of the requirements for Business Associates

The main aim of this course is to clear the confusions about the roles, requirements and responsibilities of the Business Associate, a role that is often shrouded in haziness. it is only when this is done that Business Associates will have the confidence to enter into contracts for providing services as a vendor or subcontractor. Jay will equip participants with complete understanding of what they must put in place to meet these requirements. In other words, he will help them get complete clarity on HIPAA compliance regulations for Business Associates.

The seminar will be very in-depth, as Jay will start with an understanding of the basics, such as why HIPAA was created, which will help participants get to the deeper aspects of HIPAA compliance requirements. Over the course of these two days, Jay Hodes will cover the following areas at this seminar:

  • Why was HIPAA created?
  • Who Must Comply with HIPAA Requirements?
  • What are the HIPAA Security and Privacy Rules?
  • What are the Consequences of being a Business Associate
  • What is a HIPAA Compliance Program for a Business Associate?
  • What is a HIPAA Risk Management Plan?
  • What is a HIPAA Risk Assessment?
  • What is the Role of the HIPAA Security Official?
  • What are HIPAA training requirements?
  • What is a HIPAA data breach and what happens if it occurs?
  • What are the penalties and fines for non-compliance and how to avoid them
  • Case Examples of HIPAA Data Breaches
  • Creating a Culture of Compliance
  • Q&A.

Human factors as a factor in medical devices 2017

The ANSI/AAMI HE75:2009 document describes human factors as the way in which the elements of human knowledge, such as emotional, intellectual, and physical and the sensory are used to optimize the production of devices, systems, and many others concerned with them. Human factors take not only the ways in which these human elements are used to raise productions, but also the way in which the limitations of these factors come into play. It is a field that is essentially concerned about the interaction between humans and devices or machines.

Source

Given the nature of this description, it is not surprising that human factors are important to areas such as design and aesthetics. It is an important aspect of user interface. User interface has gained a lot of acceptability and popularity following the emergence of the field of IT, but it can be used in a number of other areas. Since there is almost no area of production or science in which the user does not come into the picture; human factors can be a major factor in creating and shaping user interface for a number of products.

A major factor in medical devices

In the area of medical devices, human factors come into play in a prominent way. Although, strictly speaking, medical devices are not products into which the aesthetics is considered critical in determining consumer behavior in the way it is for say, clothing; design is an indispensable factor. Design plays a very major role in the user interface of medical devices, because these products have to be designed to absolutely precise specifications. A small deviation or variation can cause harm to humans, given the nature of the uses of medical devices. Errors can result in major consequences for patients, and subsequently, to the organization manufacturing the devices.

When it comes to medical devices, the FDA has the primary responsibility of regulating them with the intention of ensuring their safety and effectiveness. Incorporating the principles of human factors into medical devices ensures that the product meets specification, design and quality standards and thus becomes faster and less expensive to market. On account of this, human factors are becoming part of the design and development, as well as of the supplementary aspects of medical devices, such as Instructions for Use, labeling and even training.

FDA’s regulations talk about human factors in medical devices

21 CFR 820.30 emphasizes that human factors need to be taken into consideration for the following:

–       Design input: Ensuring that the needs of the patient and any others who may use the product are taken into consideration

–       Design verification: Making sure that the criteria for performance set for the medical are being consistently met, and

–       Design validation: Ensuring that the device conform to predefined user needs as well as intended uses, as also making sure that testing is carried out to ensure this function. Software validation and risk analysis are part of this testing.

In addition, the FDA has also emphasized the area of human factors in medical devices in many guidance documents and a number of upcoming Draft Guidance documents.

Explore the area of human factors in medical devices

Curious about how human factors play a role in medical devices? Want to explore the area in-depth and stretch your knowledge and imagination of human factors in medical devices? A seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance will offer this learning.

The Director of this seminar is Virginia A. Lang, Principal and Founder HirLan, Inc. and HirLan International SA. Over the course of these two days, Virginia will cover all the important areas relating to human factors in medical devices. To enroll for this important learning session, just log on to

Human Factors and Predicate Combination Products. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A complete explanation of regulations and uses of human factors in medical devices

The core aim of this seminar is to familiarize participants with the way in which human factors can be applied into medical devices. Towards covering this, she will explain all the current and upcoming human factors requirements, using which, participants will learn how to keep costs under control and reduce the time for the manufacture and marketing of their products. Those in charge of crucial functions in medical devices, such as Quality Assurance, Regulatory Affairs, Device Engineering, Device Manufacturing and Pharma/Medical Devices will gain a great deal of learning from this seminar.

Virginia will cover the following areas at this seminar:

o  Overview of Human Factors and the FDA perspective

o  Human Factors Methods and Device Product Life Cycle

o  Human Factors and Risk Analysis & Management

o  Human Factors: What Devices Require Human Factors Evaluation and Validation?

 Human Factors and Combination Products

o  Human Factors and Combination Products Submitted in an ANDA.