Don’t miss out! Offer @ $10 – Online Professional Courses

7This is a great deal. What else does one call this offer $10 deal to enhance professional skill from GlobalCompliancePanel? Wait. We are talking about $10, but did we tell you what you get for $10? Did you think it is the cost of registration for the event? Well, be prepared to get proven wrong –for the happiest of reasons. $10 is the price of a single recorded webinar that GlobalCompliancePanel is putting up at this great deal @$10 to enhance professional skills with GlobalCompliancePanel!

4Yes indeed, after all the rubbing of your eyes to confirm the truth of this seal, GlobalCompliancePanel assures you that it indeed has a great deal @$10 to enhance professional skills with GlobalCompliancePanel! Could regulatory trainings become more inexpensive and more affordable? Nowhere else in the market does one something of such high value as professional trainings in the regulatory compliance area for this price. Of course, a lot of items are available in the market for this price. Let us talk about a few toiletries. Let us talk about a few used books. Let us talk about some children’s clothing. But professional trainings that will take your profession as a regulatory compliance professional a few notches higher, at $10? Well, you can take your time to believe this, but it is true.

8This great deal @$10 to enhance professional skills with GlobalCompliancePanel is open to all professionals who want to enhance their skill and learning of the regulations in their respective domains of specialization. Who wouldn’t want to, at this price? When professional trainings in regulatory compliance becomes available at this great deal @$10 to enhance professional skills with GlobalCompliancePanel; what could be a better means to spend your ten dollars!

4What is the motive behind this offer? Simple: GlobalCompliancePanel has been a provider of professional trainings for the regulatory compliance arena for a good ten years now. It has become an established name in this area. It thought, why not make our trainings more wide-ranging and accessible to many more professionals? After all, regulations do keep changing every now and then. Shouldn’t regulatory professionals keep pace with them?

3A rich assortment of courses is available at this great deal @$10 to enhance professional skills with GlobalCompliancePanel. You can choose from trainings that help you with nuances of how to establish a reduce testing program for pharmaceutical and medical device components, where the guru of starting up, developing, implementing, managing, and remediating pharmaceutical and medical device Quality Systems, Howard Cooper, will show how to derive the benefits of systematic reduced testing program include increased compliance, smaller inventory cycles, less testing, less handling, and increased productivity and efficiency.

9Are you at odds when it comes to designing, planning and conducting effective audits? Then, why don’t you purchase this webinar that comes as part of great deal @$10 to enhance professional skills with GlobalCompliancePanel, in which Mark Roberts, Head of Roberts Consulting and Engineering (RCE), a consulting firm specializing in quality system and sterility assurance compliance, will offer his insights?

There could be no better means to improve your knowledge of regulatory requirements. And the time is now, with this great deal @$10 to enhance professional skills with GlobalCompliancePanel!

Contact Details:

https://www.globalcompliancepanel.com/webinars_home?wordpress-2017-SEO

John.robinson@globalcompliancepanel.com

Support@globalcompliancepanel.com

+1-800-447-9407

 

Seminar Calendar of Upcoming Courses – June to July – 2017

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GlobalCompliancePanel’s seminars are a wonderful opportunity for professionals in the regulatory compliance areas to understand the latest happenings and updates in the regulatory compliance areas and to implement them, something they need to climb in their professions. GlobalCompliancePanel brings together a few of the best recognized names in the field of regulatory compliance on its panel of experts. The result: Learning that is effective, valuable and helpful.

GlobalCompliancePanel’s experts help you unravel all the knowledge you need in all the areas of regulatory compliance. At these seminars which are held all over the globe, you get to interact with them in person, so that any doubt or clarification you have is sorted out by none other than the honcho. They help professionals like you implement the regulations and stay updated, so that regulatory compliance causes no stress for you.

GlobalCompliancePanel’s experts offer their insightful analysis into the issues that are of consequence to regulatory professionals in their daily work. Their thoughts help you implement the best practices of the industry into your work. They also offer updates on the latest regulatory requirements arising out of a host of the laws and issues related to regulatory compliance, including, but not limited to medical devices, food and beverages, pharmaceuticals, life sciences, biotechnology and pharmaceutical water systems.

Take a look at our upcoming webinars from GlobalCompliancePanel, which will put you on the road to learning about any area that is of importance to your profession. You can plan your learning from GlobalCompliancePanel by looking at our seminars in the next few weeks at locations of convenience to you. You can choose from a whole range of topics. See which among these trainings suit you: Design of Experiments (DOE) for Process Development and Validation, Writing and implementing effective SOP’s, new FSMA rules, risk management and device regulations, data integrity, combination products, and what have you!

Contact us today!
NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
Toll free: +1-800-447-9407
FAX : 302 288 6884
Website: http://bit.ly/Courses-June-to-July-2017

GlobalCompliancePanel announces Seasonal offers for Professionals with Flat 50% OFF on all Seminars

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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 April 30. 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 https://www.globalcompliancepanel.com/seminar?wordpress_SEO and use MGCP50 Promo Code.

This offer is valid till April 30, 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!

 

 

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

Validation of Pharmaceutical Water Systems

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Thorough and proper validation of pharmaceutical water systems is highly essential for ensuring that the pharmaceutical unit uses the right quality of water. This is very important, because water is not only the source of life for humans; it enjoys the same importance in pharmaceuticals.

A very important reason for which validation of pharmaceutical water systems is necessary is that water is not only the most widely used raw material or substance in pharmaceuticals; it is also put to a number of uses in the pharmaceutical industry, such as Quality Control, process, production and formulation. Further, water comes with its own set of unique chemical properties that are obtained because of the hydrogen bonds present in it and its polarity. This makes water versatile, since it allows the dissolution, absorption, adsorption or suspension of various different compounds.

Process for pharmaceutical water systems validationvalidation-of-pharmaceutical-water-systems

Validation of pharmaceutical water systems is carried out in three phases:

Phase I, which is the investigational phase

Phase II, the short term control phase, and

Phase III, which is the long-term control phase

Pharmaceutical water systems are validated through these three steps or stages to demonstrate and ensure that the facility using pharmaceutical water systems has water under its control and is on the right track for production of the right quality and quantity of water in the short, medium and long terms.

Validation through commissioning and qualificationPharmaceutical water systems validation is carried out through two important steps, namely commissioning and qualification. Commissioning is about putting the validation of pharmaceutical water systems through the required phases using the prerequisite methods of documentation. This documentation is a core part of pharmaceutical water systems validation because it allows for different personnel in the organization to not only keep track of the processes involved, but also make changes when necessary.

Qualification as part of pharmaceutical water systems validationQualification is the next important stage of pharmaceutical water systems validation. Here, before a pharmaceutical water systems validation process is started, the pharmaceutical facility should implement the following important steps:

  • Design qualification (DQ)
  • Installation qualification (IQ) and
  • Operational qualification (OQ)

Phase I:In Phase I, the pharmaceuticals facility samples and tests water sampling for anywhere between two and four weeks for monitoring the water system. If the water system is free of failure during this phase, it is considered a successful phase of pharmaceutical water systems validation.

Phase II:In this phase of pharmaceutical water systems validation too, the water system sample is tested intensively for two to four weeks, during which the water sample should show that it is producing the right quantity of water under conditions of stated SOP.

Phase III:Phase III of pharmaceutical water systems validation is the longest and most arduous period, running to one year after completion of Phase I and Phase II. When the water sample passes through this phase, it is said to have completed the process of pharmaceutical water systems validation and is considered fit for pharmaceutical use.

Learn more on this topic by visiting : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900882SEMINAR?wordpress-SEO

Dealing with medical device reporting and recalls

Medical device reporting and recalls have enormous benefits for the medical device company and the public if implemented properly. They can prevent use of defective devices and can be an important inoculation against stringent FDA actions.

Medical device reporting and recalls are a major FDA activity. Medical device companies have clear instructions on how to initiate medical device reporting (MDR) and recalls.

What is medical device reporting?

Procedures for medical device reporting are governed by 21 CFR 803, which has details regarding how a medical device company should go about its MDR.

Who have to make MDR?

The FDA deems it mandatory for these entities to report certain types of adverse events and product problems:

For the following entities, MDR is voluntary and is to be done when serious adverse events are detected in the medical devices they use:

  • Professionals
  • Patients
  • Caregivers, and
  • Consumers

These categories can also report issues relating to product quality, therapeutic errors and use errors.

What is a recall?

A recall can be either of these:

  • When a firm voluntarily removes or corrects an already marketed device that is found by the FDA to be in violation of its governing act on these devices, namely the Federal Food, Drug, and Cosmetic Act. Seizure of a medical device is an example of this kind of action.
  • A recall also happens when a firm voluntarily determines, after investigation, that a device is adulterated in some way. An example of this instance is misbranding, when a manufacturer discovers that the device is not fulfilling its intended use.

A recall is important for two reasons:

How does a medical device company report a recall?

Firms have to follow 21 CFR Part 806 when they have to reporting Medical Devices Recalls, as set out by The Center for Devices and Radiological Health. The Center makes it a requirement for a firm to report when the medical device is posing a risk to health. This has to be reported to the FDA District Office in which the firm is located.

Our webinars can help you gain more comprehensive knowledge of this topic and related ones. Click here (link) for details.

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Globalcompliancepanel Successfully Completed Seminar in Los Angeles -New FDA FSMA Rules

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

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