How outcome can be improved for every patient with state-of-the-art cardiac solutions

Healthcare providers and payers to quickly and securely integrate and flow data across the healthcare network.

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DXC Technology , the world’s leading independent, end-to-end IT services company, announced DXC Open Health Connect, a digital health platform that enables healthcare providers to give better quality of care and patient outcomes by enabling interoperability between disparate environments to provide data when and where it’s needed across the healthcare system.

Rising costs, increased regulations and shifting consumer expectations are leading healthcare organizations to seek efficiencies through digital transformation. According to the IDC FutureScape: Worldwide Healthcare 2018 Predictions, “By 2019, more than 50 percent of life-science and healthcare companies will have dedicated resources to support accessing, sharing and analyzing real-world evidence for use across their organizations.”

Click here to know how outcome can be improved for every patient with state-of-the-art cardiac solutions.

A connected healthcare ecosystem — including integrated delivery networks, accurate patient data and increased access to information — is essential to lowering costs, improving care quality and boosting patient outcomes. DXC’s agile, cloud-based DXC Open Health Connect enterprise platform delivers the necessary tools and blueprints to healthcare providers and payers to quickly and securely integrate and flow data across the healthcare network.

“As the healthcare industry moves away from a volume-based model in favor of outcomes-based programs, interoperability and data sharing — financial, clinical and operational — will be key to achieving enhanced patient care,” said Andrea Fiumicelli, vice president and general manager, Healthcare and Life Sciences, DXC Technology.

“The future of connected healthcare will be about collaboration and care within and beyond the walls of a hospital or clinic. DXC Open Health Connect encapsulates the future of healthcare by delivering the speed, scale, flexibility and continuous innovation necessary for clients to turn their traditional healthcare systems into major digital-health enablers.”

DXC co-created DXC Open Health Connect with a large academic and research hospital system in metropolitan New York. The solution went into production in 2017, enabling better access to all of the data and technology across the network to discover new insights that are helping to enhance patient engagement, improve operational efficiencies and boost flexibility. Ultimately, DXC Open Health Connect is enabling a shift in focus away from acute care only to concentrating more on promoting lifelong wellness.

Combining partner, product and composite application programming interfaces (APIs) with cloud services and common protocols, DXC Open Health Connect delivers faster time to value by automating deployment, personalizing the user experience and accelerating service development to seamlessly move information between disparate environments.

DXC Open Health Connect, available globally, is offered as either a technology platform or in three easy-to-consume modules:

  1. The DXC Open Health Connect interoperability module helps integrate disparate data from across the healthcare ecosystem to support the creation of an integrated care record;
  2. DXC Open Health Connect analytics provide evidence-based insights about populations and individual health to improve care; and
  3. DXC Open Health Connect’s API Director supports the ability to rapidly create new, information-rich applications while governing and controlling access to patient data. It provides enterprise security, metering, billing and policy enforcement.

The digital platform allows for the deployment of DXC Technology’s mobile applications, such as PatientAide, NurseAideand ClinicalAide, which drive appropriate behavioral changes in the healthcare ecosystem and support changes in the patient journey.

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National health targets lead to perverse outcomes

Those health targets were such a miserable failure that we have to find something that works and that’s better.

National has warned that there will be more preventable deaths in the health system now that the Government has dropped national health targets.

The performance targets for district health boards, which the former government introduced in 2009, have been stopped by the Coalition Government, and no data has been published since August 2017.

“Over time dropping the targets, losing the accountability, will mean more illnesses and more fatalities in our health system that could have been avoided,” National leader Simon Bridges told reporters today.

But Ian Powell, executive director of the Association of Salaried Medical Specialists, said that was not true.

“That’s crap. The obsessional nature of certain targets has contributed to some patients going blind,” he said.

Powell said the targets had not worked and they needed to be outcomes–based.

“They have led to superficial assessments of how the system has performed, they grossly mislead the public and they have had, especially in the context of underfunding, very perverse outcomes.

“The [Health] Minister, and we would agree with him, is looking more towards things that focus more on improved health outcomes,” he said.

Acting Prime Minister Winston Peters said the targets had been a “miserable failure”.

“It’s not correct to say we’ve dropped health targets. I just think those health targets were such a miserable failure that we have to find something that works and that’s better,” Peters told reporters this morning.

Health Minister David Clark said the Ministry of Health had stopped publishing data based on the previous government’s targets while other measures were developed.

“The previous government’s targets produced perverse incentives leading to what were traditionally cheaper surgeries being performed in more expensive environments. That meant the health dollar was not being spent as wisely as it could be,” Clark said.

“I want a health system that has honest and transparent measures, unlike the previous Government, which was pumping up its numbers by counting Avastin injections [used to treat eye disease] and skin lesion removals as surgeries when many could have been done in primary care.”

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What does the medical device/biotechnology auditor look for and why?

How to maintain cleanliness in these areas and keep them presentable for the auditor.

Audits -both internal and external -are a vital tool for ensuring that a medical device or biotechnology product and its manufacturing operations meet prescribed regulatory requirements. Medical device and biotechnology auditors have guidelines on how to establish that the manufacturer has met standards such as ISO 13485, ISO 14971, or regulations such as 21 CFR Part 820.

Apart from going by these guidelines; the auditor also uses her intuition and observation gained from personal experiences to ensure that the facility she has visited is putting in place the right mechanisms to ensure what a state of control looks like. Given that a medical device audit can happen at just about any time; it is imperative for an organization in the medical device industry to be prepared for an audit any time, all the time.

What are the points that the manufacturer has to bear in mind to ensure compliance, so that the medical device audit goes on smoothly without events? What processes and methods should it follow to pass a medical device audit? These are critical questions that the manufacturer needs to have answers for.

Thorough learning on how to think like the auditor

A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will equip participants with the knowledge needed to clear a medical device audit. José Mora, a Principal Consultant specializing in Manufacturing Engineering and Quality Systems, will be the speaker at this very important webinar. Over the more than 30 years that José worked in the medical device industry, he specialized in manufacturing, process development, tooling, and Quality Systems; he introduced process performance, problem solving, and Quality System methodologies.

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His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopedic implants and instruments, and vascular surgery grafts and textiles.

You can gain the benefit of his experience by registering for this webinar at http://bit.ly/2laaQ7G

The mental checklist

The important learning of this webinar is that José will provide insight into the auditor’s way of thinking. He will explain the kinds of clues an auditor might use in determining what areas to focus on. Rather that offer a heads-up on the regulations and standards relating to medical device audits; José will give knowledge of the general mental checklist.

Adhering to this checklist, an intuitive one created more out of the expert’s knowledge and experience rather than one gleaned from textbooks, will go a long way in determining how well an audit goes. He will also explain what kind of culture and environment a medical device organization’s management has to inculcate and encourage, so that the medical device auditor gains a better than normal perception of the organization.

An eye on the visual clues

An experienced auditor who knows her job does not need to look too far or deep to discover anomalies. The checklist she has in her mind is enough for her to match the facility’s requirements with those in it. At this webinar, José will bring his years of experience in helping participants understand how to frame a mental checklist of their own, so that they map it with that of the auditor.

He will emphasize the importance of housekeeping, proper maintenance, orderliness, and following safety rules. He will also highlight the importance of objects that serve as visual indicators in the facility, and will show how to follow them. Generally, in most medical device facilities, utility rooms and custodial closets are dumping places for several items. An experienced auditor is aware that what a medical facility hides in these places are a greater indicator of the facility’s orderliness than what are kept in the clean and presentable areas. The expert at this webinar will show how to maintain cleanliness in these areas and keep them presentable for the auditor.

José will cover these areas at this webinar:

  • What the auditor is looking for and why
  • The first five minutes
  • Touring the plant and manufacturing area
  • Entering and touring the warehouse
  • Entering and touring a cleanroom
  • Entering and touring lab areas
  • Reviewing documents
  • Reviewing the quality system
  • Summary

This course offers immense benefit to those in charge of handling auditors. These include Managers, Supervisors, Directors, and Vice-Presidents.

How to Comply with Both in the same Organization

A leading provider of professional trainings in all the areas of regulatory compliance.

Medical devices being a global market; it is not surprising to see many medical device companies marketing their products in both the US and the European Union (EU), two huge markets for these products. Given that these are two different markets; each has its own regulatory requirements. These requirements focus mainly on its Quality Management Systems (QMS). The QMS for the two markets are described in two documents: one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR 820).

On the surface, these two systems appear similar as they have many features in common. But as one delves a little into them, it turns out that they are not identical. A regulatory professional who markets medical devices into these two markets is likely to face crucial questions:

·        Is it possible, and is it permitted to have a QMS on the same site that complies with both requirements?

·        Should one QMS comply with both, and should that be put in place, or is it necessary to have two QMS coexist on the same site?

Thorough learning of the ISO and FDA QMS requirements

Answering questions such as these requires a thorough understanding of the background of both these documents, their legal status, what is expected by the regulatory authorities, and some basic concepts in quality and medical devices quality in specific. This is the learning that a webinar from Compliance4All, a leading provider of professional trainings in all the areas of regulatory compliance, will impart.

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At this webinar, Compliance4All brings the owner of ELC Consulting Services, Eyal Lerner, as expert. Eyal’s organization offers the pharmaceutical and medical devices industries support in all quality related issues, such as Preparation for inspections, CAPA and RCA, quality manual QSM, self-inspection (internal audits), compliance gap analysis, 3rd party audits (FDF and API’s), Management Review, GMP, GLP, MD: ISO 13485:2016 adjustments, DHF, DMR, V&V, 510k submission preparation and ISO 17025 (lab accreditation) and Validation. Eyal has preformed more than 100 audits in various facilities around the world as a lead auditor and auditor.

Please visit http://bit.ly/2JDpIWO to enroll for this webinar and have important doubts about the implementation of the QSRs of the ISO 13485 and 21 CFR 820 regulations clarified.

Offering insights into the two regulations

At this webinar, Eyal will give clarity to participants on how to understand what is required by both. It is necessary for regulatory professionals to understand semantic and substantial differences between the two documents. To give an example, while the ISO requires what it calls a Quality Manual (QM), the FDA QSR does not find mention of such a term. An in-depth look at the policies and Standard Operating Procedures facilitates the ease of handling of such terms. Eyal will focus on other issues that require more attention. He will explain the main features of these areas and describe what should be done from the perspective of a site or a manufacturer which wants to comply with both QMS.

The objective of this learning session is to offer a clear understanding to organizations in the medical devices industry that either develop or plan to market medical devices to USA and Europe of how to plan and implement a QMS that complies with both regulatory authorities. Eyal will help them ask themselves how to get the QMS right and make it work efficiently.

This session is aimed at professionals who are involved in implementing their organizations’ QMS, and includes Medical Devices Quality Personal (QA and QC), Laboratory Managers, R&D Researchers of Medical Devices and Combined Products, Quality Control Staff, and Regulatory Affairs (RA) Staff.

The speaker at this webinar will cover the following areas:

·        Introduction

·        Brief review of regulations and standard: status and history

·        ISO 13485:2016 short review

  • Principals
  • Quality management system
  • Management responsibility
  • Resource management
  • Product realization
  • Measurement, analysis and improvement

·        FDA QSR (21CFR820) short review

  • Quality System Requirements
  • Design Controls
  • Document Controls
  • Purchasing Controls
  • Identification and Traceability
  • Production and Process Controls
  • Acceptance activities
  • Nonconforming Product
  • Corrective and Preventive Action
  • Labeling and Packaging Control
  • Handling, Storage, Distribution, and Installation
  • Records
  • Servicing
  • Statistical Techniques

·        Comparison between both QMS

  • Common features
  • Variances between both

·        Terms/ vocabulary

  • Comparison between terms

·        Summary.

 

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How to Effectively Manage CROs/Vendors used in the [Pharmaceutical Industry]

It is imperative for pharmaceutical companies that outsource to get a thorough understanding of the elements of a sound outsourcing system.

Today’s globalized and interconnected world has made outsourcing indispensable. Outsourcing works to the benefit of both parties. Those who outsource can let other, independent companies, usually those that have specialized in this function, to take over several of their secondary processes, so that they can concentrate on the more productive and business-yielding activities. At the other end, the outsourced company earns substantial revenues by carrying out outsourced activities.

In the pharmaceutical industry, it is necessary and important to employ efficient and accurate strategies for this important activity. When projects are outsourced without proper safeguards and monitoring going into them, the outsourcing company has higher chances of inviting FDA actions such as Warning Letters, 483’s, etc.

Putting a selection process in place is very important

Companies should put in place robust structures that help them select vendors successfully and avoid scenarios such as these. These systems should also ensure that other critical aspects of outsourcing activities in GXP areas such as contract design, quality monitoring and risk minimization remain compliant. It is imperative for pharmaceutical companies that outsource to get a thorough understanding of the elements of a sound outsourcing system.

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Complete learning on how to select CROs/Vendors

A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will educate participants on the elements of managing and avoiding common pitfalls with CROs/Vendors.

Laura Brown, an independent Pharmaceutical Project Management and Training Consultant and is Course Director for the M. Sc. in Clinical Research at University of Cardiff’s School of Pharmacy; will be the speaker at this course.

Dr. Brown has over 20 years’ experience of managing clinical research projects in the pharmaceutical industry. She has worked in Project Management for several companies including Wellcome, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She is also co-author of two books on Project Management, including Pharmaceutical Project Management, a 2004 publication.

Please enroll for this webinar by visiting http://bit.ly/2JJHZVz

Learning on all elements of CROs/vendor outsourcing

At this webinar, Dr. Brown will combine theory and practical examples to offer a crucial overview of a sponsor’s responsibilities, which will give them the knowledge needed to ensure quality oversight.

In the course of this session, Dr. Brown will cover the following areas:

  • Understand how to Effectively Manage CROs/Vendors used in the Pharmaceutical Industry
  • Build an Understanding of your Responsibilities as the Sponsor or the Vendor: Identifying the Right Level of Management and Oversight
  • Discover Tools and Processes to Manage CROs/other Vendors
  • Gain an insight for CROs/other Vendors of what Sponsors Expect and how to Meet their Expectations
  • Measuring CRO Performance including Metrics and Key Performance Indicators
  • Managing and avoiding common pitfalls with CROs/Vendors.

Personnel who work in areas that involve one or more aspects of outsourcing CRO’s/vendors, such as Vendor Management, Global QA/Compliance, Contracts and Outsourcing, VPs, Directors, Outsourcing Department Staff, Purchasing, Finance and Contract, Management Staff, Managers and other personnel involved in selecting and managing cross, will benefit from this course.

Dr. Brown’s webinar is also aimed at helping personnel involved in vendor/CRO/CMO oversight (including those working in Clinical Research, Regulatory Affairs Pharmacovigilance, and Manufacturing) in the pharmaceutical, biotechnology, medical device and biologic industries who use Contract Research Organizations (CROs/CMO).

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Food Fraud in the Organic Industry

Organic food fraud and prevent potential pesticide cross contamination from previously carried loads.

A recent admission by The U.S. Department of Agriculture’s Office of the Inspector General of its failure to review required documents for products labeled as “organic” indicates a lack of controls at U.S. borders, increasing the likelihood of nonorganic products entering the U.S. under false “organic” labels.

This opens the floodgates for the entry of dubious products into the market and getting passed off as organic, without being that. In fact, many imported products that carry the organic label are not only completely non-organic; they contain GMO and pesticides.

There is no guarantee that those who consume what are labeled as organic food are consuming food that is free of adulteration by pesticides, cross contaminants, and other hazards. This, despite the establishment in 2002 of the National Organic Program (NOP) standards, which prohibit the use of sewage sludge, GMO, ionizing radiation, synthetic pesticides, synthetic fertilizers, antibiotics, growth hormones, artificial preservatives, flavors, and dyes, and cover specific labeling rules or products labeled as organic.

Whopping food fraud costs

Globally, food fraud losses are put at between $10 and $15 billion a year. As thousands of U.S. companies buy, process and sell organic products and with the organic food industry expanding in a big way by the day; there is a pressing need to protect the consumer, the industry and brand identity investment and curb pricing variations and food fraud. With organic sales jumping 23% in 2016 according to a report from Packer; the need for stopping fraudulent practices is greater than ever before.

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One of the actions taken by The US Department of Agriculture is punishing violating companies with fines up to $11,000 and encouraging reporting complaints. The USDA also lists fraudulent organic certificates and all companies legally certified as organic. There is an urgent need for food companies to review and develop new tools and technology designed to provide data that tracks and traces organic product through all processes in order to build a preventive supply chain.

Learning on how to handle organic food fraud

A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will explain these aspects in detail and will show what steps a food industry company can take to handle organic food fraud and prevent potential pesticide cross contamination from previously carried loads.

John Ryan, a highly regarded senior Quality professional, whose quality system career has spanned the manufacturing, food, transportation and Internet industries over the past 30 years, will be the speaker at this webinar. Dr. Ryan brings the rich experience of working and living extensively throughout Asia and the U.S. at the corporate and facility levels for large and small companies as a turn-around specialist. His company, Ryan Systems, works with some of the world’s leading equipment, hardware, software, training and integration companies in the business.

Please visit http://bit.ly/2JdiRHi to enroll for this valuable session.

At this webinar, Dr. Ryan will cover the following areas:

  • NOP Standards
  • Verifying the Source Organic Food Shipments
  • Controls Over Transportation of Fresh Organic Foods
    • Cross Contaminants – Sanitation Specifications
    • Procedures and Controls
    • Control over Previous Loads
    • Lack of Border Controls
    • Temperature Controls
    • Inspection
    • Food Security
    • Farmers’ Markets
  • A tracking solution that allows shippers, carriers and receivers to record and review data focused on
    • Tracking organic shipments from the source
    • Checking the shipment source against the NOP approved data base
    • Checking to assure the container or trailer for organic shipment has been cleaned according to shipper/receiver specific requirements
    • Assuring the container has been properly sealed
    • Assuring the temperature has been maintained throughout all shipment handoffs
    • Verifying conditions at the receiving end
    • Maintaining a complete record of all transactions
  • The NOP site to help you assure you are dealing with organic certified suppliers.

Food Safety and Quality in Home Food Delivery

Food suppliers have to take a relook at their strategy if they have to gain a reputation in the market as providers of hygiene.

Among the many conveniences that technology has ushered into our lives is the facility of ordering food online and eating whenever we want to, instead of having to necessarily visit hotels or restaurants. Coupled with another recent phenomenon that has changed our lives forever-globalization-the home delivery market is growing at a terrific rate. It is pegged at between $45 and $50 billion annually, and is expected to grow at a rate of more than 50% by 2022.

This huge industry, part of the wider and bigger food supply chain industry, which involves many players and activities in meeting its demand; is often characterized by ignorance about the most vital aspect of food: hygiene. This is an industry, like say, healthcare, whose efficiency depends more on the last mile provider, than on planners and high-level managers and strategists. It is this foot soldier on whom the industry actually runs, in a sense. Yet, the home food delivery market is characterized by a shocking lack of knowledge about food hygiene on the part of these delivery personnel. If this is the story of a hygiene-obsessed country such as the US; one can imagine how appalling the situation must be globally.

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One can attribute a twofold reason for this situation: the diverse and fragmented nature of the food delivery business, and the near total absence of regulation in it. It is thus an irony of the food delivery business that while the business continues to grow in terms of attractive numbers; the core aspect of food delivery, cleanliness, continues to suffer.

Regulatory controls lack teeth

Many consequences result from the lack of hygiene standards. Lack of hygiene affects products of daily use, such as poultry products, meat and other related foods. Consumers, most of whom are in the productive age group, fall sick often. When this happens, the economy’s productivity levels drop. Plus, it puts a heavy burden on the already overstretched healthcare sector.

There is the existence of a law on food safety: the FDA’s Food Safety Modernization Act (FSMA), which has rules relating to areas of the food supply chain such as distribution from the point of produce, documentation -especially for imported and exportable items- and supply chains. This fact notwithstanding, the FSMA is not potent or comprehensive enough to ensure hygiene at the critical source at which food is most vulnerable: the last mile supplier, or the food delivery point.

Get to understand the elements of food delivery hygiene

Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering a course in which the core areas of safety and sanitation aspects of home food delivery will be explained. Dr. John Ryan, a highly acclaimed expert on food safety, will be the speaker at this very high value webinar. Dr. Ryan is the Founder of John Ryan Systems, which he founded after gaining expertise in all the areas of the food safety industry for three decades, during which he worked in sectors such as manufacturing, food, transportation and Internet industries.

Please log on to http://bit.ly/2HxZTdK to enroll for this webinar and to gain insights into Dr. Ryan’s vast knowledge of the food supply industry.

Understanding the reasons for which food gets harmed

The ambit of this webinar is an explanation of the vulnerabilities that food in the food home delivery industry is exposed to. Dr. Ryan will explain the regulations that need to be complied with to ensure the safety of food, as well as the consequences of lack of compliance. Complying with regulations apart, food suppliers have to be more knowledgeable about how activities on their part can prevent disease outbreaks. Food suppliers have to take a relook at their strategy if they have to gain a reputation in the market as providers of hygiene. This is one of the major discussions of this webinar.

Dr. Ryan will explain how food supply companies that seek to get away from the reach of the law by deceptive and escapist recourses such as disclaimers can be hauled up.

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At this webinar, Dr. Ryan will cover the following areas:

  • The issues of food safety and quality
  • Basic food sanitation and temperature controls
  • Appropriate dunnage
  • Evolving home food delivery Technology
  • Types of foods in the home food delivery market
  • Ordering models
  • Recall requirements
  • Integrated Online Ordering Companies
  • Call in or online orders
  • Some of the industry players.