200+ followers. WOWWWWWW…

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Hello Everyone,

Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone.  we never expected to actually to connect with other people in the blogging community.

we are so incredibly thankful for each and every one of you who follows and comments on my blog posts. Please know that!

we would continue our blogging in these areas FDA Regulation, Medical Devices, Drugs and Biologics, Healthcare Compliance, Biotechnology, Clinical Research, Laboratory Compliance, Quality Management ,HIPAA Compliance ,OSHA Compliance, Risk Management, Trade and Logistics Compliance ,Banking and Financial Services, Auditing/Accounting & Tax, Packaging and Labeling, SOX Compliance, Environmental Compliance, Microsoft Excel Spreadsheet, Geology and Mining, Human Resources Compliance, Food Safety Compliance and etc.

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Design Control for Medical Devices

Design Control for Medical Devices 3

Design Control for medical devices is of utmost importance to the medical device industry. In order to get a grasp of its importance, one needs to get an understanding of what Design Control is. In simple terms, Design Control for medical devices is a set of logical and linear steps that medical device manufacturers have to take to ensure that:

  1. The medical device being manufactured is safe
  2. The medical device manufacturer follows all the steps and procedures for ensuring that the device it develops is what was meant to be developed
  3. Design controls for medical devices have to be put in place to ensure that the final product – the medical device – meets all the required and prescribed regulatory procedures and guidelines and meets the customer’s expectation

In short and simple terms, design controls for medical devices are verifiable and provable assurances that medical device manufacturers have taken adequate steps to guarantee that a medical device meets its set of required standards and procedures to ensure its safety and meet customer requirements.

FDA and ISO expectations of design controls for medical devicesBoth the FDA and the ISO have regulatory requirements from medical devices that expect some Design Control standards. The FDA’s requirements for design controls for medical devices are spelt out in FDA 21 CFR 820.30, while ISO 13485 is the standard for design controls for medical devices. Although formed by different regulatory or standards bodies; both the FDA 21 CFR 820.30 and the ISO 13485 are essentially similar. Their purview of the areas of design controls for medical devices is almost identically similar to each other. Sections of the FDA 21 CFR 820.30 and the ISO 13485 speak of requirements relating to the following in their various sections:

In just one area of design controls for medical devices, namely Design History File, there is a small difference, in that while the FDA’s regulatory requirements for design controls for medical devices include DHF; in the case of the ISO 13485, this is treated separately.

There is thus near total convergence between the FDA 21 CFR 820.30 and the ISO 13485 when it comes to design controls for medical devices.

Basic requirements of FDA 21 CFR 820.30 and ISO 13485Both the FDA 21 CFR 820.30 and the ISO 13485 have expectations for design controls for medical devices. These are the core areas:

designControlForMedicalDevices

Good Documentation Practice Guideline is simple: just write

Good Documentation Practices are the soul of many regulated industries. The FDA, like all other regulatory agencies, makes GDP a central element of its regulations, and bases it on the principle of evidence. For the FDA and other regulatory agencies across the world, what is not documented is nonexistent.

Good Documentation Practices are essential for a number of disciplines. The soul of documentation is, naturally, the written word. What happens when something that happened is not actually written down? It is a work of no practical use, because apart from those that carried out the particular undocumented task; no one else is aware of it. And even when the people who did that task or were witness to it are prone to have their own interpretation and perception of what was done. This is why proof in the form of writing is the most important element of Good Documentation Practices.

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What to write, and how toGDP should not only be about just writing down; it is about what to write and also, how, meaning, in what manner. If there has been an intervention in any method of manufacture or any other activity in the regulated industries; the change should be noted down in the proper format as prescribed by the FDA. This enables everyone concerned, from the people in the organization to the auditors to the regulatory agencies, to clearly identify what action was carried out, by whom and when. This further leads to a discovery of the impact of the actions. This is the key to determining the effectiveness of the application of the GDP principles in the particular case.

goodDocumentationPracticesGuidelinesThis is why the FDA has very clear-cut requirements and expectations of GDP from the industries it regulates. These clearly explain the method by which to document the said document, the ways of doing it, and what actions to take when the need arises.

Quality Assurance is unthinkable without the application of GDP principles. The main reason for establishing GDP is ensure that the documentation does the following to the record in question:

goodDocumentationPracticesGuidelines
What needs to be documented?Another major element of GDP is to determine what is to be documented. The FDA and other regulatory agencies require the principles of Good Documentation Practices to be applied across a number of activities at different stages. These include:

goodDocumentationPracticesGuidelines

The EMA’s requirements
goodDocumentationPracticesGuidelinesThe EMA also has clear-cut guidelines on Good Documentation Practices. Some of its core requirements relate to

  • Specifications
  • All aspects of the manufacturing including the product’s formulae, the way in which the processing was done, the methods of its packaging, and the extent to which its testing instructions are written down
  • SOPs
  • Protocols
  • Technical agreements

Further, most regulatory agencies have their own requirements with regard to the styling, ways by which the amendments, if any, need to be jotted down, the type of ink to be used, the way in which the review, if any, needs to be entered, and who should put signatures and where, so on. Manufacturers who fall under the purview of respective regulatory agencies need to adhere to these.

And, for other reasons, as wellImplementing Good Documentation Practices is a great idea to have for meeting regulatory requirements, because companies that do not meet these requirements are in a spot of bother about a number of issues. However, in addition to this, there is also the need for maintaining GDP for business reasons, as well. A business that complies with the requirements set out by the FDA or other regulatory agencies in relation to Good laboratory practices, the CFR regulations such as 21 CFR Parts that apply to various industries, and also as required as part of national and global agencies; earns a good name in the market and is considered a reliable company.

 

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The increasing role of the social media in healthcare

 

The increasing role of the social media in healthcare 6With the social media having moved beyond being a platform for sharing personal information; its role in healthcare has nearly exploded of late. This is mainly because the growth of the social media has more or less coincided with that of the electronic records in healthcare.

Whatever the identifiable or unidentifiable reasons for the convergence of social media in healthcare; the fact is that social media in healthcare is a major phenomenon that is here to stay.

Social media in healthcare is being analyzed for potentially huge business opportunity, and it is being taken up for serious discussion in legal circles, with the American Congress and many other legislative bodies around the world thinking of taking serious steps for regulating it.

The increasing role of the social media in healthcare 4

The most fundamental aspect of social media in healthcare is that its growth has been helped by the core feature it brings: its ease of adaption in this sector. Healthcare information, as we all know, is very vital, and speed is of great importance. This is why social media in healthcare has come to be one of the most talked about scenarios in the healthcare today, propped in no less measure by the gigantic size of the American healthcare economy.

The advantages social media brings into healthcare

 

The increasing role of the social media in healthcare 1As just seen, the social media in healthcare facilitate great use because they help transmit information at a pace that was difficult to imagine till recently. With the development of the electronic health records (EHR) in the US, technology has made possible the customization of health records. A platform like the social media can help accelerate this pace enormously. It can also help practitioners and other stakeholders of healthcare information, such as Business Associates and Covered Entities and a host of related ones gather information and transmit it and process it at lightning speed.

Concerns

The increasing role of the social media in healthcare 3

The enormous benefits that the social media bring into healthcare notwithstanding; there is room for serious concern.

Like all other technology-driven tools, the social media in healthcare comes with an inherent risk: the laxity of records. Loose or nil security or healthcare records are a serious cause for concern. The recent breaches in health data have cost many healthcare organizations in the US millions of dollars.

The social media in healthcare give an opportunity for marketers to pitch their products or services, but they also open up lots of opportunity for the unscrupulous among these to exploit and manipulate this information. This is akin to the potential drawbacks credit cards and other such facilities bring. The social media in healthcare is a tool that is open to a high degree of vulnerability to breach. This is all the more true of new technologies, such as the cloud, which the social media in healthcare have embraced with open arms.

So, while the social media in healthcare is a force to reckon with, it is not something that is totally free of drawbacks. Till regulatory action frees the sector of these, the social media in healthcare will continue to grow, albeit with its concerns.

 

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Rural health care centers provide low-cost care

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Providing health care services in rural areas is vital to addressing health disparity needs in the United States, said Candice King, the ACORN clinic’s executive director.

To get dental services she can afford, 73-year-old Juanita Jenkins has one of her sons drive her 16 miles from her home in the Duval neighborhood in northeast Gainesville to the Alachua County Organization for Rural Needs (ACORN) Clinic in Brooker. The 32-mile round trip is worth it, she says.

Jenkins is one of thousands of people in Alachua County and surrounding counties who need the inexpensive services provided by nonprofit organizations, such as ACORN, which was established in 1974 to serve area migrant workers.

“I started coming here last year and I’ve been here to the dentist about four or five times,” said Jenkins, after getting fitted for dentures. “They take good care of you here, and I would recommend their services to anybody.”

Thursday is National Rural Health Day, created to recognize rural health workers for their efforts and their collaborations that address the unique challenges faced in rural communities.

Providing health care services in rural areas is vital to addressing health disparity needs in the United States, said Candice King, the ACORN clinic’s executive director.

ACORN has grown from a singlewide trailer on a sandy lot of land to several modular buildings that house dental, medical and administrative offices at 23320 N. State Road 235 in Brooker.

The clinic provides a range of medical, dental and mental health care services, referrals to other health services and social services and professional education and training, King said.

Like ACORN, Archer Family Healthcare, an arm of the University of Florida College of Nursing, started out in a small building before moving into a larger building to better serve its patients. According to Joan Newell-Walker, manager of the clinic, retired Dr. Dee Williams lobbied to establish the clinic after being urged to do so by Archer residents. Williams’ efforts led to the clinic opening in 2001, and it has grown from an approximately 1,000-square-foot, two-story bungalow to a more than 5,000-square-foot facility composed of six modular buildings that were built in downtown Archer in 2007.

“We have grown to accommodate approximately 5,000 patient visits annually,” Newell-Walker said.

Patients visit the Archer clinic for a variety of reasons, including chronic diseases like diabetes, hypertension, chronic obstructive pulmonary disease, as well as prenatal care, medication consultations, health education and disease prevention, immunizations, physical exams and more, Newell-Walker said.

The clinic in Archer was established to meet the needs of residents who live in the rural community in southwest Alachua County who didn’t have a health care facility before the clinic opened. But it’s grown to serve patients from throughout North Central Florida, Newell-Walker said.

The clinic’s funding comes from local, state and federal sources, and it’s run by advanced registered nurse practitioners, Newell-Walker said.

The nurse practitioners provide expert care for patients and are supported by other health care professionals, including a case manager, community health nurses and a consulting physician, Newell-Walker said.

At ACORN, a wide variety of dental, medical and mental health care services are provided, including disease management education, general medical care, reduced cost X-rays, women’s health care, dental exams and X-rays, extractions, orthodontics, root canals and more.

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Health Education England launches online workshop on improving digital readiness

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Health Education England is launching an online workshop to gather views on digital readiness.

The organisation is working in collaboration with Digital Health and innovation and crowdsourcing agency Clever Together on the online workshop, which forms part of the Building a Digital Ready Workforce programme.

It will be launched on 22 November in partnership with BCS Health and Care, the Federation of Informatics Professionals in Health and Social Care, and the Faculty of Clinical Informatics.

James Freed, chief information officer at Health Education England, told Digital Health the exercise was a chance to gather the views of those who already have a strong voice as well as those who are less commonly heard.

“In almost all technological programmes I have seen, our efforts are mostly about technology and very little about process, and the process redesign, and almost none on people,” he explained. He hopes the new online workshop will address that.

Andy Kinnear, chair of BCS Health and Care, added the aim was to hear from “digital experts; the wider group of people involved in the digital space such as nurses, doctors and care professionals; and the entire health and social care workforce”.

The online workshop will run for about three weeks and its results will form the basis for how the BRDW programme will prioritise and invest £6m over the next four years. Its findings will be extensively covered by Digital Health.

You can register now for the online workshop. Our feature article gives more detail – including interviews with James Freed and Andy Kinnear. Keep an eye on Digital Health over the next few weeks for ongoing coverage.

Women’s Forum panel addresses women’s health, education challenges

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Health and education challenges that women face were the center of a panel discussion which took place Monday morning as part of the Women’s Global Leadership Forum.

Courtesy Women’s Global Leadership Forum

 

A panel addressing health and education challenges facing women took place Monday morning as part of the Women’s Global Leadership Forum. The discussion was facilitated by Rebecca Dillingham, director of the University’s Center for Global Health, and was comprised of of women who gave their global perspectives on the issues.

Newcomb Ballroom was packed with an audience that included high schoolers, University students, alumni and faculty members.

Vivian Pinn, the first full-time director of the Office of Research on Women’s Health at the National Institutes of Health, spoke briefly about being the first African-American female graduate from the University Medical School.

“I went into that first morning class in the fall of 1963 thinking that when I looked around the room and saw only white men — that the other women and people of color must just be late getting there,” Pinn said. “Then I realized that I was it. It was me and my classmates.”

Pinn said one of her main priorities she has pursued throughout her life is trying to ensure the medical world listens to women and discusses women’s health.

“I have focused on things that have been important to me my whole life,” Pinn said. “That is — What about the health of girls and women? What about girls getting careers in medicine? I couldn’t think of a better time to focus my energy on women’s health.”

The panel centralized their conversation on the importance of enabling education at a young level to facilitate greater gender equality amongst leadership roles.

Maya Ajmera, president and CEO of the Society for Science and the Public, spoke about her trip to India in which she saw train platform schools. The trip inspired her Global Fund for Children which works on behalf of vulnerable children. Ajmera said in the future she wants to focus on empowering local, grassroots organizations to enact change.

“Grassroot entrepreneurs …  They are the ones that resources really need to get put into because I think they’ve been starved,” Ajmera said. “I think they’ve been starved in this country, but I also see that starvation globally. So if we’re going to reach people, it’s through the grassroots.”

Ajmera also said one of her main priorities is to ensure that girls continue their education beyond primary school.

“We have to get the education of girls at the secondary level globally up,” Ajmera said. “The development goals of the U.N. have achieved great success in getting primary school admissions very high. But secondary school really has to be an emphasis.”

Abinet Sitotaw, a gender and nutrition advisor for nonprofit organization CARE-Ethiopia also said education was important in promoting women and girl’s empowerment. Speaking of her own personal mission and the Mandela Washington Fellowship, Sitotaw said her priorities involved getting girls into safe educational institutions.

“It’s going to be a leadership academy whereby I manage to bring a group of young girls who cannot attend secondary schools to the city,” Sitotaw said. “I want to give them a boarding school whereby they can get a state of the art education and also leadership skills.”

 

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