Progress on global poverty and disease at risk, Gates says


LONDON, Sept 13 (REUTERS) – Proposed United States budget cuts could put in jeopardy great progress in reducing global poverty and disease and lead to 5 million more deaths from AIDS alone, the philanthropist Bill Gates warned on Wednesday.

Gates, whose Bill and Melinda Gates Foundation is a major provider of global health and development funding, said there was currently “more doubt than usual about the world’s commitment to development”.

A global health report by the foundation, co-authored by the Gates and the Institute for Health Metrics and Evaluation at the University of Washington (IHME), analysed progress against diseases such as malaria, HIV/AIDS and tuberculosis.

It also tracked rates of poverty, maternal and infant death, access to contraception, sanitation and other development issues. Forecasting good and bad future scenarios, it found millions of lives hanging in the balance.

In a telephone briefing about the findings, Gates, the co-founder of Microsoft Corporation, said remarkable progress had been made in recent decades but that shifting priorities, instability and potential budget cuts could lead the world to turn away, jeopardising the gains.

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Role of ‘technology’ in home health care


At present, home-based health care is gaining significant traction and poised for transformation. Once recognized as a fragmented and unorganised sector, it is gaining ground through progressively capturing interest of entrepreneurs and investors.

It is a known fact that there is tremendous pressure on hospitals in delivering services at their facility, especially in Critical Care, something that can be easily outsourced today.

However, it has to be recognised that healthcare services being delivered in the home environment are at a remote location – unlike a hospital where it is a centralised facility. Therefore, monitoring and continuous feedback on key parameters, as relevant to the patient, are critical to have an impact on the outcome of the treatment.

This is eminently possible with appropriate use and incorporation of various technology elements.
With advancements in technology, both in IT and integration with Medical Electronics, it is possible to provide high quality care in the vicinity of a known and comfortable environment.

Technology can play an important role and impact the following areas:

1. Creating positive patient experiences

2. Creating an environment and providing data for better outcomes of the treatment

3. Enable home healthcare to be delivered in remote areas

The goal of technology-enabled home care also encompasses helping reduce need for institutional care, while alleviating financial and emotional burden that medical procedures come with. Its kernel of success lies in the common knowledge that chronic diseases can be treated in the home of the patient through appropriate and continuous monitoring. This monitoring could then trigger medical interventions that may be required, most of which can be implemented in a home care setting at a lower cost to the patient.


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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.

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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.

GCp offer 11

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Healthcare Compliance Professional Courses @ 10$ from GlobalCompliancePanel


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!

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The role of Good Documentation Practices on Compliance Activities

The role of Good Documentation Practices on Compliance Activities.

An acceptable definition of Good Documentation Practices (GDP) would be the prescribed standards by which documentation is created and maintained in the pharmaceutical industry. The FDA has set some GDP standards, but these are not the only GDP standards. There are others that come under the current Good Manufacturing Practice (cGMP).

Apart from the obvious reason of ensuring smoothness of documentation and records; another very important reason for which pharmaceutical, bioscience and healthcare companies –including their vendor partners –are obliged to observe GDP is for the reason that they invite warnings or penalties from the FDA if any noncompliance is brought to light.

Why should companies implement GDP?

The World Health Organization (WHO) has set out the purposes for which companies need to implement GDP. These are:

• It helps define the specifications and procedures for all materials and methods of manufacture and control

• GDP has to ensure that all concerned personnel know what to do and when to do it

• GDP gives the qualified and authorized persons in the organization the information using which they can decide whether or not to release a batch of a drug for sale

• It offers documented evidence, traceability and an audit trail, which will go a long way in ensuring a smooth investigation when it is necessary.

• GDP makes sure that the data needed for validation, review and statistical analysis is available with the company.

Why is compliance with GDP important?

The rationale for which the WHO has mandated the use of GDP is self-explanatory. As we have seen, the FDA and other regulatory bodies have made compliance with GDP practices mandatory. The fact of its being mandatory is the strongest reason for compliance. The aim of making compliance with GDP mandatory is to ensure that quality and other important aspects of medical devices, such as standards, are strictly adhered to.

When there is compliance with set standards for documentation; there is all-round ease and convenience in reading and understanding important documents. In order to ensure this, the following requirements are necessary to ensure quality control and assurance:

• Standard Operating Procedures (SOPs)
• Specifications
• Protocols
• Policies
• Bills of Materials (BOMs)
• Batch Record Forms
• Work Instructions (WIs)
• Checklists
• Electronic and hardcopy Quality records (e.g. non-conformance, corrective and preventative
• Forms/Log sheets
• Test Methods
• Training Assessments


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Pharmacovigilance signaling

Pharmacovigilance signaling is an important aspect of pharmacovigilance. In simple terms, it is the detection of a new safety finding within a set of safety data which requires further investigation. The World Health Organization (WHO) defines pharmacovigilance signaling thus: ““reported information on a possible causal association between an adverse event and a drug, the relationship being unclear or incompletely documented previously”.

Why is pharmacovigilance signaling important?

For a drug to enter the market, it should have gone through a series of clinical trials and tests that establish its intended use and effect. These are very stringent and should take all aspects of the drug development into consideration. They are essentially aimed at making the drug and its manufacturing process documentable, verifiable, reproducible and predictable. These trials involve the collection of a huge amount of data pertaining to important aspects of the drug. Adverse events are one of them. Pharmacovigilance signaling establishes the link between an adverse event and the data, and hence is of pivotal importance to the clinical trial.

Categories of pharmacovigilance signaling

Pharmacologists usually classify these findings into three categories:

a)     Confirmed signals: in this scenario, data indicate that there is a causal relationship between the drug and the adverse effect (AE);

b)     Refuted (or false) pharmacovigilance signaling: this is a type of signaling in which the investigation shows no causal relationship between the drug and the AE;

c)      Unconfirmed signals: this is a type of finding in which the pharmacologists decide that there is need for further investigation. This investigation is done using more data. A prime example of this is the data that is got from carrying out a post-marketing trial to study the relationship between the drug and the AE.

Data mining

Having said this; pharmacovigilance signaling goes beyond just data used at the clinical trials. Since at least the 1990’s, statistical data mining emerged as a method of pharmacovigilance signaling. These are some of the kind of databases that are used for pharmacovigilance signaling:

  • Spontaneous reporting system (SRS) databases
  • Prescription event monitoring databases
  • Electronic medical records (EMR) databases
  • Large linked administrative databases, or electronic health records (EHR) databases

The main aim of mining databases for pharmacovigilance signaling is that they help researchers have a broader set of data for reference, leading to more accuracy of their tests.


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Pharmaceutical production batch record review

We can understand pharmaceutical production batch record review as meaning the controls and processes that pharmaceutical organizations have to build into the batch records of pharmaceutical products they manufacture. This is a means to ensuring that products meet compliance standards and are easy to detect whenever a problem arises from a sample in the batch or in the entire batch.

What does the 21 CFR 211.100 (a) say?

21 CFR 211.100 (a) is clear in its expectations. This and related subsections lay out the process by which pharmaceutical production batch record review has to be done. It states that all requirements have to written down in a prescribed format. The aim is to ensure that the core qualities of the drug relating to its molecule, such as the strength, quality, purity and identity are adhered to in every batch.

WHO requirements

The World Health Organization (WHO) lists the requirements for pharmaceutical production batch record review. These are the main points that go into it:

Pharmaceutical production batch record review consists of reviewing production and quality control records being made part of the approval process of batch release. Whenever there is the slightest deviation or failure on the part of any batch to meet its specifications; this should be properly and completely investigated. To ensure the quality of pharmaceutical production batch record review; the WHO states that the investigation can extend to other batches of the same product if necessary. On any observation and action taken, there should be a written record created of the investigation. This record should include the conclusion and details of the follow-up action that was taken.

The WHO also states that retention samples from each batch of finished product should be kept for at least one year after the expiry date. These have to be kept in the prescribed methods and conditions. Pharmaceutical production batch record review requirements state that where starting materials are concerned, the retention period is two years from the date of expiry.


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43337 Livermore Common | Fremont| CA | USA | 94539