Management systems should be built on expansiveness and versatility

Management systems should be built on expansiveness and versatility. Only such a system delivers results for an organization. First of all, let us get a basic understanding of a management system: It is a system that helps smoothens and streamlines an organization functioning, enabling it to go on without hiccups.

The purpose of a management system is to put the organization on the road to the destination it has chosen for itself. This is done by instilling a system in which there are a defined set of prescriptive and hierarchical documents, and are well-defined. A prudent management system is one that enables the organization to carry out a host of dispersed functions and activities, so that time and resources are spared.

What an organization’s management system should address is an important question. Ideally, it should consist of a set of standards and practices that addresses all the aspects of the organization’s safety, health and environment management. Such a management system greases the whole process and brings efficiency, consistency, cost-effectiveness and timeliness into it.

A pivot for health and environment management systems

Businesses that use their assets for setting up and creating inputs for the various standards around the functions are effective ones. This is a proven and effective method of optimizing the efficiency of management systems, and becomes the foundation on which decisions concerning the way resources are spent within the Safety, Health & Environment (SH&E) scope of business are made. That is, a management system that becomes a hinge around which an array of functions can be performed is an efficient and effective one.

A proper management system has safety, health and environment at its core. The key to build an SH&E system that is designed along these lines is being able to first thoroughly evaluate their requirements. Organizations also need to have the farsightedness to anticipate the likely changes that could go into these functions over time. The management systems they build must have the strength, resilience and flexibility to absorb these changes. An organization that builds an SH&E system that fails to take these into account is doomed to failure and is sure to be a huge financial burden.

What can a management system that takes SH&E into consideration achieve?

The benefits of building an SH&E-accommodated management system are many. It can be used to or helps in:

o  Identifying everything that has to be managed within the function

o  Constructing a mechanism, tool, or process that manages each of those things identified. These are normally a set of standards, practices and programs that are built specifically for a particular function

o  Building the standard, practice or program so that it can be adjusted according to results

o  Building a measuring metric, benchmark or scorecard with both lagging and leading indicators

o  Building the management system in a way that is hierarchal in structure within the organization – (corporate sets and standards and the business unit builds the practice around the standard)

More on how to build a sound SH&E management

GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will organize a two-day seminar in which the principles to adapt and the thinking needed to cultivate the outlook for building such a management system will be imparted.

The Director of this seminar is James J. Thatcher, President and Owner, Global Safety Solutions LLC., who is listed as an expert witness for operational, as well as safety, health, environmental, training and security issues in the Oil and Gas industry and the mining, minerals and chemical industry. Please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900844SEMINAR?linkedin_SEO .

This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

In-depth exploration of SH&E management systems

At this seminar, James will make an in-depth exploration of management systems in the health and environmental areas. A complete understanding of SH&E, plus Training and Security (TS), which are the functions around which standards and practices are built, will be offered. He will also offer a description of the 16 functions that cover the SHE & TS world in detail. This learning is important in helping participants understand ways by which to build a standard and practice around all these 16 functions.

The 16 functions that will have a standard and practice specific to the function are:

o  Hazard identification & control

o  Occupational health & industrial hygiene

o  Incident management

o  Emergency preparedness

o  Environmental

o  Regulatory compliance

o  Reporting performance

o  Managing risk

o  Managing safety

o  Management security

o  Verification & audits

o  Document & record management

o  Contractor & service provider management

o  Competency management (training)

o  Commitment, communication and implementation

o  Managing change

In addition, in order to enable clear understanding of the topics, James will also describe the role of supporting documents, associated programs, procedures or Standard Operating Procedures (SOP) that are a part of the particular function being managed,.

Advanced human resources and employment law

Advanced human resources laws are in the offing, following the swearing in of the new President in the US. The new administration is expected to bring about a number of changes. With the firm accent of the new administration on curbing immigrant workforce, changes that could impact organizations in a number of ways can be expected to take place over the new few months.

Human resources will be the area in which these changes will strongly impact. Carrying out these changes requires making changes into employment laws. Advanced human resources and employment law will need to be implemented, because as a result of these changes into employment laws, uncertainties are expected to creep in in a number of areas of human resources. The new president has made no secret of his intentions to protect small businesses. Although not everything is clear at this stage yet, there is no doubt that changes are sure to come in.

The EEOC’s record monetary damages

While changes are to be expected of any new administration that takes charge, another existent factor could also fuel the need for grasping and implementing advanced human resources and employment law:

Employment lawsuits continue to be on the rise. In 2016, the Equal Employment Opportunity Commission (EEOC) reached the highest collection in monetary damages in its history, touching over $370 million. The EEOC has also been reporting a consistently high, record number of claims being filed by employers in the last three years.

Result of lack of understanding of advanced human resources and employment law

Employers who are not properly equipped for workplace issues and are lacking in the knowledge of advanced human resources and employment law are in greater trouble, as they could face any of these as a result:

o  Discrimination suits

o  Morale issues

o  Litigation

o  Lawyer fees

o  Employee turnover

o  Unplanned expenses

o  Settlements

o  Possible negative community image.

Thorough knowledge of advanced human resources and employment law

Any organization that wants to avoid any of these scenarios needs to have thorough and proper knowledge of advanced human resources and employment law. A two-day seminar on advanced human resources and employment law is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, to help companies prepare for the new administration, to maintain employment law compliance, as well as help avoid litigation.

The Director of this seminar is Vanessa G. Nelson, founder and President of award-winning Expert Human Resources. Vanessa has successfully saved businesses hundreds of thousands of dollars, streamlined multiple processes, and helped develop work teams.

Professionals whose work gets affected by employment laws, such as CEO, COO, Directors, Business Owners, HR Representatives, Managers, and Supervisors can derive the full benefit of Vanessa’s rich and varied experience by enrolling for this seminar. Registration for this event can be made at http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900896?Wordpress_SEO.

To avoid the high cost of employment lawsuits

No matter whether it is in a medium sized company or a large corporation that an HR professional works; the knowledge of advanced human resources and employment law and HR practices is essential to make the business successful. This is because these professionals come across a strikingly large and varied number of employment laws/issues that they have to be aware of.

Over the two days of this seminar, Vanessa will explain to participants the ways by which to deal with confusing human resource situations and how to apply employment laws correctly. She will offer clarity on the many advanced human resources and employment laws.

Other heavy costs of noncompliance with advanced human resources and employment law

The importance of this learning can be ascertained from the fact that the average lawsuit is $165,000, excluding lawyer fees. Employers may have to shell out an additional million dollars or more for a case that goes to trial. Not only is the cost of litigation damagingly high; there is a bigger cost attached to noncompliance, which results from lack of knowledge of advanced human resources and employment law: A jail term.

All these make the knowledge of advanced human resources and employment law all the more necessary. Attendance at this seminar will be valuable in helping gain the critical understanding needed of advanced human resources and employment law.

http://www.mondaq.com/unitedstates/x/554098/employee+rights+labour+relations/Labor+And+Employment+Law+Under+The+Trump+Administration+A+Brief+Overview+For+Colorado+Employers

https://www.skadden.com/insights/trump-expected-to-alter-labor-laws-policies

Design of Experiments (DoE) for Process Development and Validation

Design of Experiments (DoE) is a very important process development and validation component in several kinds of industries. DoE for process development and validation involves carrying out a number of tests recurrently and steadily over a period of time. Its responses are then observed.

DoE is important for process development and validation as it offers an understanding of the predictability and reproducibility of an experiment. Fundamentally, Design of Experiments for process development and validation seeks to rule out fluke or chance in the methods needed for bringing about control for a product.

DoE in medical devices

In the area of medical devices, guidelines for Design of Experiments for process development and validation are set out in the Global Harmonization Task Force (GHTF) Process Validation Guidance for Medical Device Manufacturers. This document offers guidance in the area of Design of Experiments for process development and validation by suggesting the exact areas in which design of experiments should be applied during Process Validation.

The GHTF guidance also suggests the use of both screening and response surface designs during Operational Qualification. It further requires Design of Experiments for process development and validation to be used during various phases of design controls. These include:

o  Design and development planning

o  Design verification

o  Design validation

o  Design transfer

o  Design changes.

Get a full understanding of Design of Experiments for process development and validation

The ways of approaching Design of Experiments for process development and validation will be topic of a two-day seminar that is being organized by GlobalCompliancePanel, a highly respected provider of professional trainings for the areas of regulatory compliance.

Jim Wisnowski, who is the cofounder of Adsurgo LLC and co-author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP, will be the Director at this seminar. In order to gain a full understanding of the principles and application of Design of Experiments for process development and validation; please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900794?linkedin-SEO .

This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

All about Design of Experiments for process development and validation

This seminar will offer total and all-round understanding of all the aspects of Design of Experiments for process development and validation.

Process development studies need to be completed before a process control plan is developed as part of an overall risk management strategy. These process development studies help gain knowledge and understanding about the impact of variation in process parameters on the variation in the product quality characteristics of the product.

An explanation of the methods used

The methodology of Design of Experiments for process development and validation offers a means for identifying process parameters, which impact product quality (critical process parameters) and determine the functional relationship that links the process parameters to those critical quality attributes.

Design of Experiments for process development and validation uses screening designs such as 2k factorial and D-optimal designs to determine critical process parameters. Design of Experiments for process development and validation use response surface designs, such as Central Composite Designs (CCDs) and I-optimal designs for fashioning the functional relationship between those critical process parameters and the critical quality attributes.

A primer on statistical analysis

This seminar on Design of Experiments for process development and validation will present a primer on statistical analysis, during which it will focus on the methods required for analysis of designed experiments. Jim will then move on to the steps to a proper DoE, during the process of which he will demonstrate the nature and uses of important risk management tools such as Ishikawa and FMEA, which can be used pre and post DOE studies.

The Director will also teach how to generate and analyze multiple screening and response surface designs, and why and how each are used. After teaching participants how to present the results, Jim will explain how to update the risk management tools using the results of the studies.

This session on Design of Experiments for process development and validation will cover the following areas:

o  Identify critical quality attributes (CQAs) that will be used as responses in your designs

o  Utilize risk management tools to identify and prioritize potential critical process parameters

o  Identify critical process parameters and develop a functional relationship between those process parameters and your critical-to-quality attributes (CQAs) using both screening and response surface designs

o  Be able to design and analyze screening designs including a factorial, fractional factorial, and D-optimal design

o  Understand the need for adding center points to a design

o  Be able to design and analyze response surface designs including central composite designs (CCDs), Box-Behnken designs, and I-optimal designs

o  Present results of DOE studies

o  Use systematic understanding from DOE studies to update the control plan that is part of the overall risk management plan.

All about HIPAA compliance

HIPAA compliance is a must for Covered Entities and their Business Associates. It is a sine qua non requirement from the Department of Health and Human Services (HHS), a US federal department that is charged with the responsibility of enhancing and protecting the wellbeing and health of all Americans. It provides the means for bringing about effective health, as well as human services. Its mission is to engender improvements and developments in the fields of public health, medicine and social services.

The HHS requires complete compliance with its laws by a Covered Entity and its Business Associate. The HHS’ Office for Civil Rights (OCR) considers Covered Entity as one that is involved in generating, storing, receiving or transmitting electronic Protected Health Information (PHI). A Business Associate is one that does all these on behalf of its affiliated CE. HIPAA compliance is mandatory because the nature of information that Business Associates carry with them –Protected Health Information –is of a highly confidential and sensitive nature. Not only that; when there is a breach of data on the part of the Business Associate or the Covered Entity, it results in huge costs by way of damages. Data breaches also carry a bigger penalty: They dent the reputation of the business, something no money can compensate.

Locating the source of data breach

Most of the patient information breaches take place at the Business Associate’s end. This makes compliance with HIPAA compliance rules by BA’s all the more important. The basic reason for which most such breaches take place is the many misconceptions that abound among healthcare organizations about the nature of the HIPAA privacy and security regulations. What these regulations are, what they mean to healthcare organizations, and the steps that the healthcare organizations, Covered Entities and their Business Associates need to do –all these are areas of considerable confusion.

It is to equip professionals from the healthcare industry with the complete knowledge needed to understand and implement HIPAA compliance that GlobalCompliancePanel, a highly popular provider of professional trainings for all the areas of regulatory compliance, will be organizing a two-day seminar.

A complete roundup of HIPAA compliance

Senior healthcare professional Jim Wener, who brings four decades of experience in the industry and has been assisting providers and payers in identifying their automation requirements and helping them select and successfully implement the ideal automation for their needs, will the Director of this seminar. To gain the benefit of the vast experience that Jim brings and to ensure total HIPAA compliance for your organization; please register for this seminar by logging on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900874?wordpress-SEO.

Questions, questions, questions

At this seminar, Jim will take the participants through HIPAA compliance from start to compliance. He will provide answers to all the questions that Business Associates and Covered Entities face during the process of ensuring HIPAA compliance. He will show what healthcare organizations need to do to secure their healthcare information.

Some of the questions that he will seek to answer include:

Do the HIPAA regulations apply to the organization? What risks does the organization face, and how does it mitigate these risks? What is it that the organization is required to do, and how is this done? Is there a role assigned for and expected of the organization’s computer resources in assessing and managing HIPAA compliance risks? What is the level of safety that the healthcare organization’s computer and paper patient information carry? Is there a way by which the organization determines if its computer resources provide the needed features and functions for the organization to become compliant?

Diligence can lessen the severity of penalties

These are just some of the questions for which Jim will seek to provide answers. Framing these questions and answering them is a watertight means to developing and executing a compliant plan. This in turn is critical to ensure that the organization takes the right path in ensuring HIPAA compliance. A breach is a very bad thing to happen for an organization, but diligence that the organization has showed in protecting patient information will go a long way in mitigating penalties. This is one of the prime reasons for which attendance at this seminar is necessary.

• What is HIPAA, who is covered and what is HIPAA Compliance
• Why the healthcare organization should be concerned about HIPAA compliance
• How to perform a HIPAA Risk Assessment
• How to prepare HIPAA Policies and Procedures
• How to perform HIPAA Training
• What is IT’s role in the healthcare organization’s HIPAA Compliance
• How to prepare a Business Continuation/Disaster Recovery Plan
• How to handle a potential HIPAA Breach.

https://www.hhs.gov/about/index.html

 

GlobalCompliancePanel Professional Training and Development Courses with Flat 50% OFF on all Seminars

Do celebrations need a cause and a reason? Yes, and GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, is having a solid cause and reason for doing so. It is celebrating the many years of its relationship with its customers spread all over the world by offering its trainings at a massive 50% discount!

Yes, that is right. GlobalCompliancePanel’s seminars will be available for a huge 50% discount till March 31. Regulatory professionals who want to augment their knowledge of regulatory compliance can now do so by paying just half the price of these trainings from GlobalCompliancePanel. All that is needed to do walk away with a rare offer such as this is to visit http://www.globalcompliancepanel.com/ and use MGCP50 Promo Code.

This offer is valid till March 31, 2017. Regulatory professionals who want to take any of GlobalCompliancePanel’s trainings can book their trainings for an area of their interest by this date. From April 1 onwards, this offer will cease, meaning that the original price will apply from then.

So, why is GlobalCompliancePanel offering this discount? It is for a simple, but profound reason: It wants to thank its huge customer base for the support they have been extending to this company over the many years for which it has been in business. During the course of the 10 years for which GlobalCompliancePanel has been in business, it has trained thousands of regulatory compliance professionals from around the world.

These professionals, belonging to such varied geographies as the US and Japan and India and Canada, have been able to meet their regulatory compliance challenges on account of these trainings. These trainings are relevant, focused and valuable, and are from some of the best known regulatory compliance Experts found anywhere on this planet.

It is these trainings that have been hoping these professionals in the regulatory compliance arena gain more insights into regulations from the FDA, the EMA and other such bodies around the world. These trainings have been consistently helping them to meet these challenges, as they give them a better and sharper understanding of the implementing these requirements.

These regulatory requirements can pose hurdles to the most experienced and brightest of regulatory compliance professionals in the medical devices, pharmaceutical, life sciences and food and biologicals areas, but not to those who undertake professional trainings from GlobalCompliancePanel. GlobalCompliancePanel’s panel of experts is here to help them overcome these challenges and hurdles.

This trend has been being witnessed from the time GlobalCompliancePanel entered the line of professional trainings. Any wonder then, that no fewer than 50,000 professionals have benefited from these trainings? What could be a better way of thanking such a huge base of customers than with this offer? GlobalCompliancePanel believes that a celebration should also be useful, and this is that this offer is!

Hurry up and enroll today. Happy learning!

New FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods and adherence to them

The U.S. Food and Drug Administration (FDA) is in the process of finalising food safety rules. A major part of these rules is devoted to the ways by which to ensure scientific and safe transportation and logistics food transportation. The FDA is required to establish rules for that improve, audit and enforce new rules relating to food transportation. This is something required by the Food Safety Modernization Act (FSMA), under congressional instructions.

Many aspects of food transportation come under the ambit of these new FSMA Rules. These include:

–       Foods not completely enclosed by a container

–       Prevention and reduction in adulteration and risk

–       Personnel training and certification for this purpose

–       Inspecting food and collecting data

–       Maintaining compliance and reporting about its evidence.

How to do this right?

Comprehension of all the FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods is necessary and important for organizations that work in food transportation. They also need to know how to implement these rules. It is this understanding that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will offer at a seminar it is organizing.

The Director of this two-day seminar is John Ryan, President, TransCert, QualityInFoodSafety, RyanSystems. To gain insights into how to understand all the aspects of the FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods and to understand how to comply with them, just register for this session by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900810?wordpress-SEO . This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion

At this seminar, the Director will arm participants with an understanding of the legal requirements of food transportation and how to develop a company plan that meets the expectations and requirements of both its customers and the FDA. Also offered is total understanding and review of the ways of establishing the right temperature monitoring, sanitation, container test and traceability, training and data reporting procedures.

Technological aspects of FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods

Technological aspects of food transportation are gaining importance. These include new low cost GPS enabled traceability and temperature monitoring technology, EPA approved container sanitizers, washout technologies, temperature maintenance equipment, and food residue and bio-contaminant testing. FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods have a close relationship with these. The Director of this seminar will take these up for examination.

In reviewing the future of transportation food safety in the light of new and evolving technologies; the Director will dot the seminar with references to upcoming technology providers and provide Internet links to detailed information on the same.

This seminar is immensely useful for food supply chain logistics and food safety and security personnel whose primary responsibilities include management, sanitation, quality and operations. Those involved with handling incoming and outgoing food shipments, maintaining transportation equipment and tools, and purchasing or selling will also derive high value out of this seminar.

Team development is an integral part of leadership

Team development is a critical aspect of leadership, because leaders, like statesmen, think about the next generation. Leaders not only select and mentor leaders; they also make sure the leadership abilities get transferred to the new generation. For this reason, taking the organization to its next destination and grooming leaders requires team development. Team development is an extremely important endeavor for a leader.

Team development and leadership are closely hemmed together, because a team that lacks good leadership focus and direction will never be a winning one. There are many vital differences between leadership and management. Leading from the front and building a team is one of the prime distinctions between a leader and a manager, because these traits are never expected from a manager. Many leaders are up against many situations. These are some of them:

o  Knowing when to manage and when to lead the team

o  Foreseeing and visualizing organizational goals and communicating them to the team

o  Ascertaining the market’s needs and helping the team channelize its efforts more effectively

o  Addressing workplace challenges by devising creative solutions for the team

o  Devising strategies to develop a high-performance team

o  Communicating effectively to motivate and coach.

Learn all about leadership and team development

A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will equip participants with the insights needed for understanding all these aspects of leadership and team development. The essence of this session is to equip participants with the skills and knowledge needed to inspire their team members and help them reach their goals.

Gaining these insights is easy. You can register for this webinar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900818?wordpress-SEO .

The Director of this seminar is Chris DeVany, who is Founder and President of Pinnacle Performance Improvement Worldwide. The varied experience he has had, in having helped some 500 organizations such as Microsoft, Coca-Cola, Aviva, and Schlumberger in 22 countries, will come to the fore at this seminar.

Leadership and team development in all their depth

DeVany will offer a thorough understanding of the role of leadership in building a team and working in a horizontal mode of operation and applying a consistent theory in leading a team.

This session will be very useful for CEOs, Senior Vice Presidents, Vice Presidents, Executive Directors, Managing Directors, Regional Vice Presidents, Area Supervisors, and Managers.

Chris will cover the following areas at this seminar:

o  Understanding leadership style and the situation

o  Integrating your leadership and managerial roles

o  Examining the leader’s role as motivator and coach and in high-performance teams

o  Distinguishing the three team types

o  Exploring the principles that make teams work

o  Differentiating team content and process

o  Diagnosing work-teams: a work-team simulation.

Today’s Article on Understanding the HIPAA Privacy Rule, Security Rule and Breach Notification Rules and their compliance

The Health Insurance Portability and Accountability Act (HIPAA)’s Privacy, Security, and Breach Notification Rules are aimed at protecting the privacy, as well as the security aspects of health information. This set of rules has the intention of providing individuals with some rights on information relating to their health.

This is how the three rules need to be understood:

The Privacy Rule: Sets out standards about the conditions to be met for using and disclosing Protected Health Information (PHI). This Rule applies nationally.

The Security Rule: Specifies the kinds of safeguards that Covered Entities and Business Associates have to put in place and implement for protecting electronic Protected Health Information (ePHI) and ensure that they remain confidential and are made available when required, and have integrity.

The Breach Notification Rule: Covered Entities have to report breach of unsecured PHI to the affected individuals and the HHS. In some situations, this has to be reported to the media, as well. The Breach Notification Rule has details on how this is to be done. Generally, a window period of 60 days is given from the date of detection of the breach. Small breaches, meaning breaches that affect lesser than 500 individuals, may be directly reported to the HHS annually.

Purview of the HIPAA Privacy Rule and Security Rule

Privacy Rule: HIPAA Privacy Rule has standards on how to protect PHI held by the following: Health plans, healthcare clearinghouses, healthcare providers; part of whose healthcare transactions are carried out electronically, and Business Associates

Security Rule: HIPAA Security Rule sets out standards and guidelines on the steps that Covered Entities and Business Associates have to take to ensure that Protected Health Information is confidential, has integrity and is made available when needed. The Security Rule describes how these qualities in the ePHI created, maintained or transmitted by them.

Knowledge of all these aspects is very necessary if the Covered Entity or Business Associate has to ensure HIPAA compliance. The task of HIPAA compliance does not become possible with just a reading of the rules and the procedures. Expert advice on how to actually implement the requirements is needed.

This is what a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will offer. At this seminar, Jim Sheldon Dean, Director of Compliance Services, Lewis Creek Systems, LLC, will be the Director.

In order to gain complete understanding of the HIPAA Privacy Rule, Security Rule and the Breach Notification Rules, and to understand ways by which to ensure compliance with them in a way that satisfies the regulatory authorities, please register for this seminar by logging on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900754?linkedin-SEO .

Jim Sheldon Dean will explain the requirements of HIPAA, how to prevent incidents, and how to survive audits, so that penalties can be avoided. He will offer an explanation of the background to HIPAA, and detail what a manager of healthcare information privacy and security has to know about the most important privacy and security issues. He will also show how to ensure HIPAA compliance, and explain the consequences of inadequate HIPAA compliance.

This seminar will provide in-depth understanding on the major aspects of HIPAA compliance, such as:

o  The new features of the regulations

o  The recent changes

o  The aspects that Covered Entities and Business Associates need to address if they have to remain compliant.

Learning on all aspects of HIPAA Privacy Rule, Security Rule and Breach Notification Rules

Jim will also explain audits and enforcements. He will also describe privacy and security breaches and explain how to avoid them. He will enrich the learning by providing sample documents and references.

Jim will cover the following areas at this two-day session:

o  Overview of HIPAA Regulations

o  HIPAA Privacy Rule Principles, Policies and Procedures

o  Recent and Proposed Changes to the HIPAA Rules

o  HIPAA Security Rule Principles

o  HIPAA Security Policies and Procedures and Audits

o  Risk Analysis for Security and Meaningful Use

o  Risk Mitigation and Compliance Remediation

o  Documentation, Training, Drills and Self-Audits.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/HIPAAPrivacyandSecurityTextOnly.pdf

GMPs for API Bulk Manufacturers

Till recently, till 2001 that is, Good Manufacturing Practices for Active Pharmaceutical Ingredients (APIs) bulk manufacturers was carrying a bulky load on its shoulders, so to speak. GMP for active pharmaceutical ingredients (APIs) per se had no independent guidelines. The GMPs that they were to follow and implement were bunched with those of APIs for bulk manufacturers. So, GMPs for API bulk manufacturers consisted of GMPs for both APIs and API bulk manufacturer.

All that changed, however, in 2001, with the FDA’s issuance of a draft guideline called Q7A, which was meant separately and exclusively for APIs alone. This draft guideline was meant solely for APIs, and GMPs for API bulk manufacturers were exempt from the provisions of the new guideline.

No clear guideline yetThat said, while the FDA draft guidance of 2001 merely separated GMPs for APIs; it did not make any changes to the existing GMPs for API bulk manufacturers, which continued to remain the same and continued to suffer the same insufficiency. The major deficit that plagued GMPs for API bulk manufacturers continued to do so. As in the past, there was no guideline on GMPs for API bulk manufacturers at all. Instead, all that was required was that bulk manufacturers go by their heart. In other words, the onus of maintaining GMPs for API bulk manufacturers was left to them, based on their unique individual needs and situations.

Leaves it to the individual pharma organizationThe FDA and other regulatory bodies merely require that established practices be followed as GMPs for API bulk manufacturers. This, as noted, leaves the task of ensuring that conception and implementation of all-round GMPs for API bulk manufacturers to the individual organization, based on its discretion and assessment of what it deems as appropriate. The following are the areas into which pharmaceutical organizations may take steps at implementing GMPs for API bulk manufacturers:

• Manufacturing equipment
• Components that go into the materials and packaging
• Requirements relating to record-keeping
• Facilities and buildings
• Personnel
• Process controls
• Laboratory controls

Learn more on this topic for your reference: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900964SEMINAR?Linkedin-SEO

Breaking down the rules into steps makes HIPAA compliance less complicated

HIPAA compliance is a legal requirement for Business Associates and Covered Entities. The Health Insurance Portability and Accountability Act (HIPAA) was enacted in 1996 with two main intentions:

o  To enable employees to keep their insurance intact when they switched jobs or their insurance provider

o  To facilitate the payment and information process by putting in place a uniform code for these.

From its start, up to 2013, HIPAA has undergone a few changes, such as:

o  The privacy regulation additions of 2003;

o  The insertion of the HIPAA Security Rule in 2005;

o  The passage of the HITECH Act in 2009, and

o  The addition of the Omnibus Rule in 2013, with the intention of extending liability to Business Associates

With the insertion of these additions, HIPAA compliance has become more and more demanding and complex, or at least that is what most entities who are required to comply with it feel. Most Business Associates and Covered Entities have issues with the following areas of HIPAA compliance:

–       The 18 identifiers that Protected Health Information (PHI) consists of; with the name, full face photos, e-mail address, and date of birth of the patients being some of their constituents

–       The requirement of designation, by every organization or practice, of a privacy officer, who has to carry out a risk analysis

–       The requirement, as part of HIPAA compliance, of covered health care providers and health plans, of developing and distributing a notice, in which the privacy rights and practices relating to patients’ personal health information have to be clearly explained.

Despite these requirements, HIPAA compliance is not as difficult as it seems

The reality, however, is different. HIPAA compliance is not as complicated and difficult as it is thought to be. At first glance, these requirements may appear to be intimidating. Yet, when it comes to practical application, HIPAA compliance is not really all that cumbersome or difficult. All that is needed is a clear-cut understanding and explanation of the major sections on compliance.

This clear-cut understanding of the major sections on which many Covered Entities and their Business Associates face difficulties is the intention of a seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance.

At this detailed two-day seminar, Paul Hales, an attorney at law in St. Louis, Missouri who specializes in HIPAA Privacy and Security Rules, will be the Director. All that is needed to gain a thorough understanding of the perspectives Paul will offer on HIPAA compliance is to register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900798?linkedin-SEO .

What makes this seminar a valuable learning session is that Paul will explain, in simple and plain language, the contents of HIPAA compliance. He will demystify the tricky areas of HIPAA compliance and offer clarity of understanding of these, and will crystallize them into six easy steps.

Paul will drive home the point that HIPAA compliance becomes easier when its seemingly difficult requirements are broken down into steps. He will suggest six steps that organizations can take to make HIPAA compliance easier.

He will pack the seminar with visual presentations, interactive discussions and stimulating questions and answer sessions. He will also show how to find the right rule with the six step-by-step procedures he will lay down.

Takeaways at this important seminar on HIPAA compliance

Paul will offer these following key takeaways at this highly valuable seminar:

·        Thorough Understanding of HIPAA Rules

• What they are
• How they work together
• Why and How they were made
• How they are changing and what to expect next

·        HIPAA Risk Analysis – Risk Management for Your Organization

• A Practical Guided Exercise done in class on your computer to take home

·        Privacy and Security Rules – Permitted and Required Uses and Disclosures

• What information must be protected
• Administrative, Technical and Physical Safeguards
• Social Media, Texting and Emailing Patients

·        The inter-connected, inter-dependent relationship of Covered Entities and Business Associates

·        What is, and what is not a Reportable Breach of Unsecured PHI

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