Learn any professional courses for $10 only

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Want to enhance your regulatory compliance career by learning a new course? All that it costs is $10. Yes, GlobalCompliancePanel, a provider of professional trainings, is offering hundreds of high value regulatory compliance courses for a mere $10 each.

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Regulatory compliance learning, that vital ingredient needed for professionals in any area of regulatory compliance, is a put off, because many professionals consider it expensive. But not anymore. GlobalCompliancePanel makes it possible to scale up in one’s career. What used to cost $265 is now available for $ 10, at about the price of a T-shirt. See the math: It is a saving of about 95%.

Myriad number of courses

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Regulatory compliance, as we all know, is a really vast area of knowledge. With the FDA framing innumerable laws and regulations on every area that it regulates, it is imperative for regulatory professional to show compliance with the regulations. They are doomed if they fail. GlobalCompliancePanel brings hundreds of courses in all the areas of regulatory compliance to help professionals understand how to meet these stringent standards.

GCp offer 10

Want to explore what expectations the FDA has of the drug development process? Want to understand the nitty gritty of drug development and how to meet the FDA’s stringent requirements as far as IND and NDA requirements, or nonclinical or the human clinical studies required for it? Then, take a look at how GlobalCompliancePanel can help you achieve this, for just $10.

Are you working in an industry in which you are required to carry out Root Cause Analysis, but are having problems with it? Understand the fundamentals of Root Cause Analysis and get to know how to determine what caused the problem, why it happened, and what to do about it to reduce its likeliness of occurrence, with this course from GlobalCompliancePanel.

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Have you understood how to get HACCP validation done for your facility? Do you have a problem in grasping its validation and verification? No worry. This recorded webinar from GlobalCompliancePanel will set you on the path to it. At just $10, it will offer you the knowledge you need for understanding how to tackle supplier and other issues and put in place a robust HACCP validation and verification program.

This is just a small sample of the many courses that are on offer for $10 each. Want to explore how many more courses are on offer at this huge discount price? Then, just visit our website to open up the possibility of unlimited learning. All that you need to spend is just $10 to enhance your learning on an area of regulatory compliance.

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Health Buzz: The 10 Best States for Health Care

 

Health Buzz The 10 Best States for Health CareIf you want to get the best health care, you might be better off living in one of these states, according to a new ranking.

Hawaii, Iowa and Minnesota topped WalletHub’s new ranking of the best states for health care. The ranking took into account 35 metrics in the categories of cost, accessibility and health outcomes.

Among access-to-care metrics, the highest percent of insured adults (ages 18 to 64) live in Massachusetts, the District of Columbia, Vermont, Hawaii and Minnesota. The lowest live in Georgia, New Mexico, Nevada, Florida and Texas.

As for outcome metrics, like lowest cancer rate, New Mexico, Nevada, Arizona, Colorado and Utah ranked in the top five, while New York, Pennsylvania, Louisiana, Delaware and Kentucky ranked in the bottom five.

U.S. News ranks its own Best States for Health Care, in which Hawaii also stands at No. 1.

Health care concerns, though always present, have been thrust into the national conversation even more this year amid legislative attempts to reform former President Barack Obama’s health care law.

The Senate recently failed to pass a health care bill. Sens. Susan Collins (R-Maine), Lisa Murkowski (R-Alaska) and John McCain (R-Ariz.) voted against the Republicans’ attempt to overhaul the Affordable Care Act, commonly known as Obamacare.

A recent report from the Commonwealth Fund found that the U.S. has the worst health care system compared to other high-income countries. The U.S. ranked lowest for health outcomes despite outspending its peers, according to the report.

But in its own health care analysis, the Kaiser Family Foundation discovered the U.S. system has made progress, especially with “its ability to promote health and provide high-quality care, with some recent improvement in the accessibility of that care and a slowing of spending growth.”

Americans typically spend approximately $10,000 each year on personal health care, and that number is expected to rise, according to the Centers for Medicare & Medicaid Services.

WalletHub’s top 10 states for health care are listed below, and a complete list can be found here.

Overall Rank State ‘Outcomes’ Rank
1 Hawaii 1
2 Iowa 13
2 Minnesota 8
4 New Hampshire 7
5 District of Columbia 37
6 Connecticut 5
7 South Dakota 24
8 Vermont 3
9 Massachusetts 2
10 Rhode Island 10

Seminar Calendar of Upcoming Courses – June to July – 2017

Upcoming-Courses-for-French-Circles-Club

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

Ensuring that analytical data in laboratories are accurate, reliable and consistent

Ensuring that analytical data are reliable, consistent and accurate is the fundamental reason for which analytical methods and procedures need to be validated. The employment of proper scientific methods and procedures by laboratories and validating them ensures the reliability, consistency and accuracy of the analytical data.

The purpose of doing so is to corroborate the suitability of intended use of a particular test and to confirm that the product produced in the laboratory meets the requirements of quality, purity, identity and strength in the required and set measure.

The imperative for validation of analytical data

The reason for which analytical data has to be validated for the criteria described above can be summarized in the following:

o  Because of the direct relationship it has to the quality of the data it validates;

o  To make sure that the analytical data is trustworthy;, and

o  Finally, validation, verification and transfer of analytical methods are a regulatory requirement, as set out by the different regulatory bodies such as the FDA and the EMA, and standards such as the USP and ICH.

Method validation and compendial methods

Of late, method validation has been receiving very high attention from both regulatory agencies and industry task forces alike. Both the FDA and the EMA have recently released guidelines on method validation and transfer. In addition, USP has suggested new chapters for approaches to the following:

o  Integrated validation

o  Verification and transfer of analytical procedures

o  Equivalency testing and for statistical evaluation.

What about compendial methods?

The verification of compendial methods is needed to demonstrate two aspects:

o  The suitability of laboratories to successfully run the method, and

o  To demonstrate through testing that transfer of methods, when carried on between laboratories, is successful. When a laboratory intends to use an alternative method in place of a compendial method, verification of compendial measures should establish the equivalency of the alternative method.

Comprehensive learning on validation, verification and transfer of analytical methods

A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance will address all the issues relating to validation, verification and transfer of analytical methods. At this seminar, Ludwig Huber, the director and editor of Labcompliance, the global online resource for validation and compliance and highly respected author of several books on compliance, will be Director.

To gain the full knowledge of all areas relating to validation, verification and transfer of analytical methods; register by logging on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900858?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.

Contents of the two-day seminar

Over the course of these two days, Huber will equip participants with the background needed for getting a proper understanding of the requirements that need to go into validation, verification and transfer of analytical methods. An even more significant learning he will offer is the one on strategies needed for this.

He will provide tools to implement most critical requirements. Also provided are templates and examples for developing inspection-ready documentation. Interactivity will be a major component of this seminar. Huber will sprinkle workshop exercises into and between the presentations. Around half of the total time will be dedicated to practical sessions with real life examples.

An additional bonus for participants is the assortment of tools the Director of this seminar will offer, such as SOPs, validation examples and checklists, all of which will be made readily available on a dedicated website, and which can be used to easily implement the learning gained in the course.

Preparing premarket submissions that win regulatory approval

Preparing premarket submissions that win regulatory approval is a complex task, even for the most seasoned professional in the medical devices industry. This is because of the highly stringent nature of the regulatory approval pathways, namely the Premarket Approval (PMA) process and FDA regulatory 510(k) clearance.

What makes preparing premarket submissions that win regulatory approval challenging? It is the fact, acknowledged by the FDA itself, that the PMA is the most stringent type of device marketing application required by the FDA. The PMA should be secured from the FDA before the company markets the medical device. The FDA gives its approval of the PMA for a Class II medical device only after it determines that all the elements necessary for assuring that the application has enough scientific confirmation that it is safe and effective for the intended uses it is going to be put to. Preparing premarket submissions thus is an onerous task by any stretch of imagination.

Another element of preparing premarket submissions that win regulatory approval

Another aspect of preparing premarket submissions is the 510 (k). The 510 (k) is essentially a kind of premarket submission that is made to the FDA to show that the device that a manufacturer intends to market is at least as effective and safe as a legally marketed device of its equivalence, already in the market, that is not subject to PMA. The FDA calls this principle the substantial equivalency (SE) and the device that is used as the reference for equivalence, the predicate device. The requirements governing SE are contained in 21 CFR 807.92(a) (3).

On top of all these, regulatory professionals have the responsibility of creating preparing premarket submissions that should not only convincingly demonstrate the ways of stating and explaining regulatory arguments for their device to the U.S. FDA reviewer for getting the approval; they should also be presentable and well-organized, without being cluttered or confusing.

Professional trainings for preparing premarket submissions that win regulatory approval

Given all these, it goes without saying that a completely thorough understanding and knowledge of the relevant U.S. FDA laws, regulations and requirements is absolutely necessary for regulatory professionals. This in-depth understanding can be had only from thorough training, which is indispensable if the medical device company is to win a clearance or approval.

The ways by which to do this is the core learning a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will impart. The Director of this seminar is Subhash Patel, a very senior regulatory professional and founder of New Jersey-based MD Reg Consulting LLC, which serves medical device industry clients in all aspects of global regulatory affairs specific to their needs.

To enroll for this highly valuable training session on how to successfully prepare 510(k)/Pre-IDE/IDE and PMA premarket submissions that secure clearances and approvals from the FDA, please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900776SEMINAR?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.

The grasp needed for preparing premarket submission that win regulatory approval

At this seminar, Patel will demonstrate the grasp that regulatory professionals in the medical devices industry need for working with the FDA officials during the review and approval process of their submission. He will offer a complete understanding of the major aspects of FDA premarket submissions.

While knowledge of the regulatory process is one thing; medical device companies also need to know how to set and state regulatory arguments for their device in a most convincing manner to the FDA reviewer. This knowledge will be part of this course. In the process of explaining how to prepare premarket submissions that win regulatory approval; Patel will also offer tips and suggestions to participants on how to work effectively with the U.S. FDA officials during review and approval process of their submission.

During the course of these two days, Patel will cover the following core elements of how to prepare premarket submissions. He will explain the following:

o  History and background of U.S FDA Laws and Regulations

o  Classify Your Device

o  Choose the Correct Premarket Submission for your device

o  Compile the Appropriate Information for your Premarket Submission

o  Author and Prepare your Premarket Submission

o  Submit your Premarket Submission to the FDA

o  Interact with FDA Staff during Review and Approval

o  Complete the Establishment Registration and Device Listing

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/default.htm

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm

HIPAA survival needs intimate knowledge of the nuances of the law

HIPAA survival is one of the great challenges for a healthcare entity. HIPAA audits are complex, and they need understanding of the jargon and the semantics of the words mentioned in the document to survive. Both the Covered Entity and the Business Associate need to know exactly what to do in order to pass a HIPAA audit. This is all the more important and necessary considering that the federal budget has plans of raising the budget for the OCR in 2017 by about 10% over 2016, reflecting just how serious the OCR is about HIPAA audits.

When one considers that Phase 2 of HIPAA requires compliance with something like 180 areas and allows just 10 days for response; it goes without saying that HIPAA survival is a high priority for Covered Entities and their Business Associates. Moreover, the OCR’s audit protocol clearly states that those entities that are being audited have to furnish the exact documents required and not offer broad references to policy documents.

Being even slightly lax in being prepared for Phase 2 HIPAA audits can lead to difficulties at the audit. So, HIPAA survival entails having to be one’s toes all the time and having all the edges covered and leaving nothing to chance. HIPAA survival is about putting a process in place and overseeing and implementing it with utmost diligence and attentiveness all the time.

Covered Entities and Business Associates are the target of HIPAA audits

So, where do all these place Covered Entities and Business Associates that are the target of HIPAA audits? There is simply no room for complacence. They have to be absolutely on their guard when facing HIPAA audits. HIPAA survival has to be cultivated as a means for this. The more they hard-wire the art of HIPAA survival into their practice, the better.

The ways by which Covered Entities and Business Associates deal with HIPAA survival is the subject of a two-day seminar that GlobalCompliancePanel, a highly popular provider of professional trainings for the areas of regulatory compliance, will be organizing. To enroll for this highly useful and important session on HIPAA survival, jus log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900780SEMINAR?HIPAA-survival-Chicago-IL.

At this seminar, Brian L Tuttle, a senior Compliance Consultant & IT Manager at InGauge Healthcare Solutions, will educate regulatory compliance professionals about how practice managers need to prepare for HIPAA audits. This seminar will address major changes under the Omnibus Rule and any other applicable updates for 2017. Brian will also cover other related, critical areas such as:

o  Texting

o  Email

o  Encryption

o  Medical messaging

o  Voice data, and

o  Risk factors as they relate to IT.

Brian will dispel many of the myths covering this convoluted law. He will discuss the do’s and don’ts of HIPAA survival, and will also cover the critical area of the highest risk factors for being sued for wrongful disclosures of PHI and the manner in which patients are now using state laws to sue for wrongful disclosures.

During the course of this seminar, Brian will cover the following areas:

o  History of HIPAA

o  HITECH

o  HIPAA Omnibus Rule

o  How to perform a HIPAA Security Risk Assessment

o  What is involved in a Federal audit and how is it conducted

o  Risk factors for a federal audit

o  EHR and HIPAA

o  Business Continuity/Disaster Recovery Planning

o  Business Associates and HIPAA

o  In depth discussions on IT down to the nuts and bolts

o  BYOD

o  Risk factors that can cause an audit (low hanging fruit)

o  New rules which grant states ability to sue citing HIPAA on behalf of a patient

o  New funding measures

https://www.onr.com/blog/hipaa-audits-increase-2016-2017/

GMP Compliance for Pharmaceutical Laboratories

In order to ensure GMP compliance, pharmaceutical laboratories have to devise a holistic and long term plan that covers all aspects of the laboratory’s activities.

Good Manufacturing Practices (GMP) requirements for laboratories have been set out by various regulatory bodies. The aim of GMP compliance for a pharmaceutical laboratory is to ensure that

  • Products must meet high quality standards consistently
  • They should fulfil their intended use
  • Policymaking
  • They must be compliant with the requirements set out in the Marketing Authorization (MA) or product specification

Result of guidelines from various regulatory authorities

Guidelines for GMP compliance for pharmaceutical laboratories are issued in conjunction with related regulations and guidelines. Some of these are

  • ICH, consisting of guidance documents of respective member countries, numbered as Q7, Q8, Q9 and Q3D
  • PIC/S: Pharmaceutical Inspection Convention/Cooperation Scheme
  • GMP regulations of EU and the US
  • European and US pharmacopeias, with suggestions on implementing USP regulations such as 1058, 1224, 1226, 232/233

GMP compliance for a pharmaceutical laboratory consists of

In essence, we can understand the core of FDA Medical Device GMP Guidelines to mean the

The next important stage in ensuring compliance across all workflow steps consists of compliance across all workflow steps. These include

To make GMP compliance for a pharmaceutical laboratory comprehensive, the laboratory should put in place a comprehensive compliance master plan, which

 

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