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

http://www.fertilitybridge.com/blog/hipaaandsocialmediawithpaulhales

Article on Effective techniques for extracting information from geochemical data are largely ignored by the industry

In the area of geochemical data analysis techniques and obtaining geochemical extracting information; most mining specialists strongly recommend an approach that goes beyond merely asking the laboratory for geochemical extracting information of a gold test by sampling every meter of the drill core of a trench and using multielement analysis. There, however, exist other methods of geochemical data analysis techniques and obtaining geochemical extracting information. But these are largely ignored by the industry.

As a result of following only one method and technique for geochemical data analysis and obtaining geochemical extracting information, an average geologist is not generally well trained on the necessary techniques and methods. Whenever a request for such data mining techniques analyses comes up, the geologist is short of the techniques and methods needed for geochemical extracting information, including the use of compositional data analysis. This results in failure in the endeavor of extracting all the geochemical data analysis information contained in the data.

Insight into how to use geochemical data analysis techniques and obtaining geochemical extracting information

Noting the deficiency in the methods used for optimal geochemical data analysis techniques and obtaining geochemical extracting information; GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, is organizing a two-day learning session that inculcates the right learning in this area.

At this seminar, Ricardo Valls, a professional geologist with thirty years in the mining industry, will be the Director. He brings the vast wealth of experience of the extensive geological, geochemical, and mining experience, managerial skills, research techniques, and training he has gained by carrying out various projects globally, into this seminar. To benefit from this seminar, please register for it by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900828?linkedin-SEO . This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Simplifying the geochemical extracting information to make sense

Geologists, Geochemists, Exploration personnel, Graduate students and Postgraduate students will find this course very useful, as it will give them an understanding of how to simplify and make sense of the geochemical extracting information. The speaker will demonstrate all types of analyses that can be requested. This will help participants in their exploration goal of finding the new ore body.

This seminar will help mining professionals understand how to extract all the important information of their data, including the use of compositional data analysis.

Valls will cover the following areas at this seminar on obtaining geochemical extracting information:

–       How to determine the type of sampling

–       How to determine the type of assays

–       General processing of the data

–       Compositional Data Analysis

–       Representing the results

In the process of explaining the ways of obtaining geochemical extracting information; Valls will set the following agenda for this seminar:

How to determine the type of sampling

·                    Mechanical anomalies

·                    Chemical anomalies

·                    Chemo-mechanical anomalies

·                    Scale of work

How to determine the type of assays

·                    What are you looking for?

·                    What the laboratory can offer?

QA&QC in the field and in the laboratory

·                    QA&QC in the field

·                    QA&QC in the laboratory

General processing of the data

·                    Preparing the data

·                    The problem of zeros and b.d.l. data

·                    Hurricane values

·                    Distribution law

·                    Preparing the data for further analysis.

Compositional Data Analysis

·                    Brief introduction

·                    Comparing CDa with normal statistics

·                    ALR

·                    CLR

·                    ILR

Processing major elements

·                    Statistical processing

·                    Determining the most probable magmatic event.

Processing trace elements

·                    Statistical processing

·                    Estimating the erosional level

·                    Determining geochemical indexes

Graphical representation of the results

·                    Variograms

·                    SURFER