Learn any professional courses for $10 only

GCP Offer 4

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.

GCP offer 7

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

GCp offer 9

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.

GCP offer 8

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.

GCp offer 11

Contact US:

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com

support@globalcompliancepanel.com

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

Website: http://www.globalcompliancepanel.com

Registration Link –

https://www.globalcompliancepanel.com/webinars_home?wordpress-seo-gcp-webinar-offer-2017

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

 

 

 

 

 

Healthcare Compliance Professional Courses @ 10$ from GlobalCompliancePanel

globalcompliancepanel1.jpg

Healthcare professionals now have a stronger reason than ever before to enroll for professional learning courses and upgrade their knowledge. GlobalCompliancePanel, a highly reputable provider of professional trainings for all the areas of regulatory compliance, will offer a pick of their healthcare compliance courses for just $10.

Healthcare professionals have always been flocking to GlobalCompliancePanel to partake of professional trainings courses that are valuable, relevant and highly interesting. They will now have more reasons for doing so and join thousands of healthcare regulatory professionals who have already benefited from GlobalCompliancePanel’s professional trainings, because it is not every day that one comes across an offer in which the professional gets to pay a mere 5% of the original price of the webinars!

These recorded webinars are on a number of topics concerning healthcare. Healthcare professionals can use these courses to augment the learning they have gained over the years and climb up in their professions with even greater ease. What’s more; healthcare professionals have such a huge number and variety of courses to choose from that they can opt for several courses of relevance to them without burning a hole in the pocket.

Why is GlobalCompliancePanel doing this? Simple: It wants more and more healthcare professionals to take up courses that are relevant and valuable to them, so that the knowledge needed for becoming successful in their careers spreads wider and goes deeper. After all, meeting regulatory compliance requirements is the number one challenge for any healthcare professional, who sees no way out of the regulatory maze without the professional trainings needed to understand them. When such a course is available at a throwaway price of $10, isn’t that a delightful thing to have?

Let us feature a couple of the topics on which GlobalCompliancePanel is offering these courses to healthcare regulatory professionals:

The HITECH Acts Impact on HIPAA

HIPAA enforcement is a matter of serious concern to many healthcare professionals. Many of them, even highly experienced ones, are clueless about some of the aspects of this enigmatic law. When HITECH combines with HIPAA; the confusion is doubled. The two laws intersect at many places, thus compounding the complexity of enforcement. This webinar from GlobalCompliancePanel offers clarity and helps them ease the confusion about this law.

Further, the nature and roles of a host of HIPAA-related items such as breach notification, business associate contracts, training of staff and security of PHI for Business Associates can be daunting to understand and implement. Webinars such as this are designed to help healthcare professionals steer clear of the stumbling blocks that they could encounter in implementing these.

Preparing a Medical Product Regulatory Requirement Plan

What happens when healthcare companies fail to meet regulatory requirements set out by the FDA and other regulatory agencies? The consequences are disastrous, and can range from penalties to having their business shut down. One of the foundations to avoiding this sort of situation is to develop a medical product regulatory requirement plan.

A medical product regulatory requirement plan charts out the regulatory requirements  that need to be met from step one, which is quite literally Day One of the start of the process of making healthcare products. A detailed and organized medical product regulatory requirement plan is indispensable to ensuring in the end that the healthcare product meets the regulatory requirements.

It is this priceless learning that this webinar from GlobalCompliancePanel imparts. And yes, at $10!

Drug Safety and Pharmacovigilance

Pharmacovigilance, a crucial area of healthcare, needs to be implemented in full according to the requirements set out in regulations from the FDA, EMA and other regulatory agencies. Drug safety being deeply tied to PV; the proper implementation of the latter is needed to ensure the former.

PV is essentially about ensuring drug safety by implementing measures throughout the process of production. A healthcare company has to comply with directions from a number of regulatory agencies in order to have its products passed by them and to gain permission to enter different markets. They cannot afford to take one wrong step in the whole process. A number of areas such as clinical trials, marketing, disease management and government are just some of the areas in which pharmacovigilance is indispensable.

This webinar from GlobalCompliancePanel is a great means to getting a complete understanding of this intricate topic. The topic is of great relevance to healthcare professionals, but what’s more; it comes at this unbelievable price tag of just $10!

Contact Details:

http://www.globalcompliancepanel.com/webinars_home

John.robinson@globalcompliancepanel.com

Support@globalcompliancepanel.com

+1-800-447-9407

 

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

Understanding the FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials

The establishment of the initial safety of a drug is the primary reason for which early clinical trials are conducted. Phase I of drug development consists of:

o  Research and drug discovery

o  Preclinical development, of which initial IND, or first in humans (also called first in man), is part

o  Clinical development, which consists of Phase I, Phase 2 and Phase 3 clinical pharmacology studies

Phase I studies are designed mainly for investigating the following qualities of an investigational drug in humans:

o  The extent to which it is safe and tolerable: (if possible, identify its Maximum Tolerated Dose (MTD)

o  Pharmacokinetics

o  Pharmacodynamics of an investigational drug in humans.

The ultimate goal of these Phase I and later studies is to ensure that the right drug is given to the right patient in the right dose, at the right time. These clinical studies are carried out to determine which dose or dosing regimen of the target drug achieves all its objectives for all the populations groups for which it is being developed.

Rationale for a small sample

Generally, these studies are carried out on a small sample of subjects of normal health. These early clinical trials normally use lower doses of the drug product. On account of this, the organization or laboratory carrying out these early stage clinical studies uses only small amounts of investigational material.

This is because of two reasons: The small sample is chosen in such a fashion that it is a representation of the whole study in relation to various parameters, and two, choosing a small sample substantially reduces the costs associated with a largescale study. It also reduces the regulatory burden during these early stages. Keeping in mind these factors, the FDA has established guidelines by which early stage investigational products can be allowed to be manufactured under less stringent GMPs.

Not meeting regulatory requirements makes the exercise futile

Without an understanding of the FDA’s guidelines for these GMPs, the whole exercise of early or Phase I studies becomes wasteful and meaningless. All along, the FDA’s guidelines have to be consistently and accurately adhered to in order to meet compliance requirements, without which the clinical trial and its results do not get approved.

What are the steps that a clinical or pharmaceutical organization need to take in order to ensure that these GMPs for Phase I clinical trials are being met? All the aspects of this topic will be covered in depth over two days of intense learning that will be imparted at a seminar from GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance.

Peggy Berry, the President and CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development, will be the Director of this seminar. All that is needed to gain from the rich wealth of Peggy’s experience is to register for this seminar by logging on to Good Manufacturing Practices . This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A complete explanation of the FDA’s GMP requirements

This seminar is being organized to help participants gain an understanding of the requirements for advancing drugs from research into early clinical development and the minimum FDA requirements for Phase I GMPs. She will help them learn practical applications for implementing Phase I manufacturing strategies to meet FDA requirements.

Towards this end, Peggy will discuss these topics to lay the foundation and basis for advancing drugs into clinical development from research and providing required information to the FDA regarding these products on Day 1:

o  Moving a Product out of R&D

o  CMC Requirements for an IND Study

o  Good Manufacturing Practices: Basics for Beginners

o  Raw Material Management

Taking off from these topics, Peggy will focus on the topics relating to the requirements for early stage products of different types and for vendor selection and management on Day 2, which include:

o  GMPs for Phase I IND products

o  GMPs for Combination Products and 505(b)(2) Products

o  Process Validation for Early Stage GMP

o  Outsourcing Early Stage Manufacturing.

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.

The Design History File (DHF), the Technical File (TF) and the Design Dossier (DD)

The Design History File (DHF), the Technical File (TF) and the Design Dossier (DD) are core regulatory documents for a medical device. This is how one can understand the central difference between them: the Design History File (along with Design Control), is the most important among the regulatory documents that the FDA requires for medical devices, while the Technical File and Design Dossier are documents that serve the same purpose, however, within the EU’s regulatory body, the Medical Device Directive (MDD). These documents constitute core regulatory requirements within these regulatory bodies.

The DHF on the one hand, and the TF and the Design Dossier on the other, have a lot of similarities as well as dissimilarities with each other. At a basic level, the major similarity between them is their intended purpose, while what they should contain is the main difference between the two.

If US medical device companies seeking to go global have to compete at a global level, they must meet an assortment of product design documentation standards. The Design Control and the Design History File (DHF) are mandated by the FDA’s CGMPs in 21 CFR 820.30, while for the EU; the core requirement is its CE-marking documentation –the Technical File or Design Dossier, as described in the MDD.

A thorough understanding of Design History File, the Technical File and the Design Dossier is necessary

All the complexities and in-depth clarification relating to these subtle matters about medical device regulatory requirements will be unraveled at a two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance. John E Lincoln, who is Principal of J. E. Lincoln and Associates LLC, a consulting company and a senior Consultant in the Medical device and Regulatory Affairs areas, will be the Director at this seminar.

This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion. To register for this seminar, please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900746?linkedin-SEO .

Complete knowledge of Design History File, the Technical File and the Design Dossier

At this seminar, Lincoln will examine the existing and proposed requirements for the FDA’s DHF, which includes a discussion of its derivative documents, the DMR and DHR. He will explain what the European Union’s MDD TF/DD requirements are, along with an evaluation of the documents’ differing purposes and goals, their similarities, as well as the two different device classification schemes. All important aspects relating to these areas will be taken up.

These are some of the topics Lincoln will take up for discussion:

o  Areas requiring frequent re-evaluation or update

o  Similarities and differences

o  Future trends

o  Typical DHF Table of Contents

o  Technical File or Design Dossier Table of Contents

o  The importance and usefulness of the “Essential Requirements”

o  Structure of the “Declaration of Conformity”

o  Self-declaring or Notified-Body reviewed

o  Parallel approaches to development

o  The differing approaches to file audits by the U.S. FDA and the EU Notified Body.

Useful session for companies that need to handle Design History File, the Technical File and the Design Dossier

Being a seminar aimed at helping participants understand US and global standards for medical devices; it will offer valuable assistance to all regulated companies that need to implement, review and/or modify their Device History Files, Device Master Records, Device History Records, Technical Files or Design Dossiers, documents, and activities/plan(s).

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

o  The Design Control requirements of the CGMPs, 21 CFR 820.30

o  The Design History File – documenting Product Design Control and its nine elements

o  The Device Master Record and the Device History Record

o  The EU’s Medical Device Directive

o  The “Essential Requirements”; and their documentation

o  The remaining elements of a Technical File / Design Dossier

o  Trends

o  Two attendee projects.