10 Reasons Human Error in the Life Sciences Is Going to Be Big in 2019

The aim of this webinar is to lead the participants to an exploration of all the important aspects of human error.

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Can human error happen in the life sciences scenario, where improvements keep happening in all its areas, ranging from processes to manufacturing to technology?  Although these developments are a fact, it is equally true that human error can and do happen in all settings.

In the pharmaceutical manufacturing industry, human error can result in disastrous consequence that can lead to loss of product to injury to patients. This is one of the areas of the life sciences in which human error is rather frequent. And, this occurs even in manufacturing units in which all preventive actions, such as effective compliance documentation development and training, were taken.

Interestingly, human error in itself may not be the cause of problems. It is accepted in the pharmaceutical manufacturing industry that, sometimes, rather than the root cause, i.e., concerning the product itself, the cause of adverse events may be auxiliary reasons such as lack of attention to detail or failure to follow procedure. In such cases, such companies need to take corrective actions that give greater attention to tackle these smaller aspects. Typically, these could include re-training or disciplinary action.

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A learning session that Compliance4All, a leading provider of professional training for all the areas of regulatory compliance is organizing on September 23, will seek to answer all aspects relating to human error in the life sciences. At this webinar, which is of sixty minutes’ duration, Compliance4All brings the President of C. H. Paul Consulting, Inc., Charles H. Paul, as the speaker.

Please visit https://www.compliance4all.com/control/w_product/~product_id=502698LIVE to register for this webinar and gain valuable insights into how to avoid human errors in the pharmaceutical manufacturing areas.

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The aim of this webinar is to lead the participants to an exploration of all the important aspects of human error. The speaker will help them understand the following:

  • The true causes and nature of human error
  • The method of investigating human error
  • The relationship between human error and human performance
  • The difference between real human error and systems, process, and management deficiencies.

The following areas will be covered at this webinar:

  • What is Human Error?
  • Nature of human error in pharmaceutical manufacturing
  • Approaches to investigating Human Error
  • The root causes that are directly attributable to Human Error
  • The role of leadership in Human Error reduction
  • Human Error Reduction Strategies
  • Human Error Prevention and Reduction Drivers

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About the expert:  Paul’s company, C. H. Paul Consulting, Inc., is a regulatory, manufacturing, training, and technical documentation consulting firm. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.

Apart from holding senior positions in consulting and in corporate training development, he has also worked for several years in government contracting, where he has managed the development of significant Army-wide training development contracts. His work has impacted virtually all of the active Army and changed the training paradigm throughout the military.

Tools Everyone in the Off-label Claims In Social Media Industry Should Be Using

The FDA is worried about potentially false information about it that could reach people through the social media, even if the consumer is not the one who has published it.

Did you know that your use of the social media in certain ways can be violative of the sweeping and highly generalized definition that the FDA has of labeling? This definition is so broad in its reach that it considers what is said or represented, even by images, in a social media platform, as labeling, whose violation can attract penalties!

The FDA is very finicky about what is broadcast on the social media because information pertaining to it can be false. If false information reaches a consumer, it opens up the path to many unnecessary consequences and complex actions. The FDA is worried about potentially false information about it that could reach people through the social media, even if the consumer is not the one who has published it.

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A big challenge for such companies is how to monitor and counter what someone else is saying about their product in a public forum. They need to be aware of the scope of their responsibility when such off-label information goes out into the open.

In-depth and accurate knowledge of delicate aspects such as this will be imparted at a webinar that Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is organizing on September 23.

Casper Uldriks, who owns the firm, Encore Insight LLC, will be the speaker at this meaningful and valuable session. Please enroll for it be visiting https://www.compliance4all.com/control/w_product/~product_id=502654LIVE

The main focus areas of this very interactive webinar include what is considered “off-label”, using social media website “likes” and links, the many pitfalls associated with Direct to Consumer promotion, and how to disseminate and absorb what the FDA considers fair and balanced information.

At this sixty-minute session, Casper will cover the following areas:

  • Understand how social media is labeling
  • Learn how third parties place you in jeopardy
  • Understand FDA’s concern about “fair and balanced” information
  • Ways to define your social media responsibilities
  • Apply FDA Guidance Documents on DTC/social media labelling.

About the speaker:

Casper Uldriks, who owns the firm, Encore Insight LLC, specialized in the FDA’s medical device program as a field investigator, and served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements.

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AI Changing the Face of Agriculture in Modernised World

Agriculture these days isn’t restricted to old skool farming rather farmers are shifting towards modernizing nearly each farming method through new-age technology.

Agriculture these days isn’t restricted to old skool farming rather farmers are shifting towards modernizing nearly each farming method through new-age technology. Agricultural communities are using AI in wonderful ways that to remodel food cultivation culture.

Variable Rate Planting Equipment for Sowing the Seeds:

High-tech agriculture comes into the image since the seed is seeded within the ground. In fact, with variable rate planting instrumentation sowing down the seed has taken associate degree innovative flip, it’s not remained simply planting a seed down.

The AI-centric technologies produce a base through predictions – that place is best to grow the seed, what’s the condition of the soil, is soil condition favorable for seed, etc. AI is applied to agricultural huge knowledge to create farming additional productive and economical.

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Robotic Harvesting Equipment for Picking Up Food:

Several firms are manufacturing robotic harvest instrumentation to fill the labor gaps whereas harvesting crops like fruits and berries.

A company named Harvest Coo has developed associate degree autonomous strawberry selecting machine. the corporate has additionally created copious artificial intelligence that harvests mature apples from trees through vacuum equipment.

The berry picker operates on the grounds of machine vision and detector fusion to spot wherever harvest fruit and berries are. Such technology uses subtle directed movements to choose accurately. This practicality lies beneath the AI class and imitates human knowledge and actions.

These technologies are bridging the gap of the labor force and additionally saves humans from repetitive and mundane task or probably most troublesome job of our economy. The harvest artificial intelligence within the gift may be a vital landmark in fast the modernization of agriculture.

Unmanned Aerial Vehicle:

Today unmanned aerial vehicles or drones are used with precision sensors to run the fields and gather data needed. Such surveillance engines can spot stunted crops, signs for pest or weed damage, dryness and certain other adverse conditions that may cause difficulty in farming.

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With all these data, farmers can improve their production models and their techniques and ways to decrease risk, waste, and liability.

Controlling Pest and Weed Through See and Spray Model

Farmers these days are adopting new high-tech manners of protecting plants against weeds and pest outdoors. To protect these, farming in the greenhouse can also be considered as an alternative.

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Alignment of Business Strategies with Technology

Generally, the authoritative objectives are imparted similarly as improved money related execution and continued market aggressiveness.

Data Technology (IT) has transformed into an essential bit of basically every division. As needs be, associations have select necessities for their specialized speculation. New advances should now diminish costs, increment security, improve productivity or improve work procedures and correspondences. Regardless, despite the noteworthy activity IT system plays, it every now and again ends up as a thought everything considered. Dashed on to the business framework, as opposed to encircling a crucial bit of it.

This is oftentimes in light of the fact that IT is seen as an alternate component. One where advancement drives speculations, instead of the business’ own one of a kind points and goals.

A study from business consultancy firm West Monroe found that the larger part (53%) of respondents are working more with their IT gatherings, and 43% of those respondents said they had coordinated effort based issues doing all things considered. From poor composed and verbal correspondence to absence of cooperation, these issues were deferred key zones, for instance, productivity and assurance. Specifically, 71% uncovered deferred or postponed undertakings, 43% had a lower nature of work, and 33% missed due dates, the examination says.

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IT Business arrangement is portrayed as the dynamic consummation of authoritative targets and objectives and the operationalization of the IT frameworks according to those objectives. Generally, the authoritative objectives are imparted similarly as improved money related execution and continued market aggressiveness. For instance, organizations can express that using IT, they intend to extend deals and incomes by 20% and diminishing expenses by 10% and increment benefits by 15% and achieve gainfulness.

Further, organizations may similarly need to express their market-based focuses, for instance, expanded piece of the pie wherein they intend to go into fresher bits and widen their extension in built up areas with IT. Thusly, IT-business arrangement is the legitimate capacity to utilize the past for the accomplishment of the last mentioned. This suggests for an organization to ensure that its IT and business approachs are adjusted, there must be concordance among them and alongside zero grating between the boss in corporate/business divisions and the IT office.

Issues till now:

The issues begin with the inheritance relationship IT has had with the rest of the association, says Christopher McFarlane, lithe undertaking administrator and guide with Walmart Canada in Ontario, Canada. Further, he added that regularly ones go to IT when one has an issue or one needs workstations with equipment arrangement or something like that. It’s commonly a ticketing structure, so we need this done, we continue to finish it, and from that point forward, we’ll watch out for you when it’s done.

Innovation focused representatives need to work close by various gatherings, so each can give indications of better appreciation of each other, says Zlatko Vucetic, CEO of FocusVision, an advanced statistical surveying consultancy.

Late research by FocusVision and Forrester found that various brands need customer understanding in light of the siloed structures of IT, promoting, and look into divisions. The detachment between these divisions infers that they don’t have a hold on what data matters most in forming techniques identified with publicizing, client administration, and item improvement, to give a few models.

More read at https://www.analyticsinsight.net/alignment-of-business-strategies-with-technology/

Implementing a Practical Technology Transfer Process

Execution of that move is mind boggling including the connections of numerous controls over an association.

The ideas related with actualizing a painstakingly characterized specialized and business administration programs alongside plainly characterized R&D to site move ventures for fruitful usage.

It will cover the ideas related with moving the logical innovation expected to make the item, procedures to guarantee the getting fabricating office is prepared for the item and devices and formats to help catch the information.

  • Characterize innovation move
  • Distinguish components of the business procedure structure for overseeing innovation moves
  • Distinguish New Product move process
  • Clarify advantages of innovation move
  • Decide components of an effective innovation move

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Fruitful exchange of pharmaceutical items and their procedures is basic to the effective dispatch. Its prosperity guarantees that results of the most astounding quality are conveyed to the patients alongside gathering the business requests of the organization. Anyway execution of that move is mind boggling including the connections of numerous controls over an association.

  • The importance of technology transfer

Who will get the benefit by this:

  • Senior quality Managers
  • Quality Professionals
  • Regulatory Professionals
  • Compliance Professionals
  • Production Supervisors
  • Manufacturing Engineers
  • Production Engineers
  • Process Owners
  • Quality Engineers
  • Quality Auditors
  • Development Professionals
  • Senior Development Managers

About the instructor:

Steven Laurenz Chemical Engineering M.S. – Michigan State University Expertise: Over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization. Skilled in taking new products from early laboratory stage to successful manufacturing launch. Expert in integrating Quality by Design and risk management into product development. Experience in establishing a Quality System for a R&D Quality Assurance organization. Experience: Headed product development departments at Abbott Laboratories and AbbVie Inc. Leadership positions in numerous technical consortium. Other: Black Belt certified in Business Excellence and Master Certificate in Applied Statistic.

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Where’s Robotic-Assisted Surgery Headed?

Space for a great deal of mechanical innovation to help a wide broadness of surgeries.

Will Intuitive Surgical’s da Vinci framework be ousted as the business chief? Can one automated stage handle all medical procedures? Will self-sufficient robots take over in medical procedure? These themes and more were handled during MD&M East’s June 12 board exchange, “Mechanical Surgery – Visions of the Future.” Led by Shana Leonard, Informa Markets’ VP of substance, the board included Gianluca De Novi, PhD, CEO at XSurgical; Anthony Fernando, Chief Operating Officer and CTO at TransEnterix; and Dave Saunders, boss innovation officer at Galen Robotics.

“When you truly take a gander at the business, there’s likely 40, 50 careful robots that are in reality out there,” said Saunders. “Natural Surgical fills a specialty, and they make a great deal of cash doing it for stomach and urological medical procedures. There are bunches of things that the da Vinci does not and can’t do. . . . There are bunches of medical procedures that are unmistakable to how my innovation is upgraded that I don’t think da Vinci could ever be proper for either. What’s more, they don’t have an impetus to streamline their innovation for the sorts of regions I’m following since it would add up to overengineering. . . . What’s more, in the event that we take a gander at the ongoing securing of Auris by Johnson and Johnson, that robot completes a quite certain thing that is extraordinarily high effect, yet its utilization and utility is amazingly restricted. It’s sort of marvel medical procedure.”

In this way, “there is nobody innovation that is fitting for all things,” Saunders kept, including that the three automated stages from every one of the speakers “fill altogether different specialties. . . . Every robot is streamlined for the sorts of medical procedures that it needs to go into. What’s more, when you take a gander at the business, strengths are fragmented, so I’m following neurosurgeons, otolaryngologists, though you’re managing stomach medical procedures and general medical procedures,” he stated, addressing another specialist. “There’s simply various markets also regarding who’s obtaining the robots, so I feel all around emphatically that the business has a ton of development potential, and there is space for a great deal of mechanical innovation to help a wide broadness of surgeries,” he said.

“Rivalry drives advancement,” included Fernando of TransEnterix. “There’s a lot of space for different organizations to come in and contend. . . . There’s a chance to advance in various ways, and in medical procedure as well as numerous different partners you can please as a feature of presenting mechanical technology.”

“You have to include a specific level of curiosity,” De Novi said. “You truly need to make something that is powerful and dependable however . . . nobody else can do and patients can profit.”

As far as difficulties, the greatest could be repayment. “It’s extremely troublesome right now particularly in the U.S. since there aren’t a particular repayments that will enable you to do mechanical autonomy medical procedure. . . . You need to fit in the current financial model,” Saunders said. “So I need to construct a robot that has incredible utility for specialists, yet I must have something that fits into their financial aspects. What’s more, if that isn’t a thought forthright, the organization will have no footing.”

Notwithstanding tending to financial matters, mechanical autonomy organizations additionally need to drive proficiency. “Productivity should be calculated in light of the fact that it’s anticipated just in the U.S. a deficiency of specialists in the following 10 years. So whatever innovation, your apply autonomy should be essentially more effective than today so as to not feel any effect on the medicinal services framework overall,” Fernando called attention to.

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Problems Everyone Has With INTEGRATED FOOD SAFETY SYSTEM (IFSS) – How To Solved Them

It allows no duplication of any transaction, however small or big. Needless to say, this has unimaginable consequences for the future of finance.

There is no doubt that blockchain is one of the technologies that are going to change the future of money and business. Blockchain is, in simple terms, a method by which every transaction is accounted for and taken as original. It allows no duplication of any transaction, however small or big. Needless to say, this has unimaginable consequences for the future of finance.

While this is the good news about blockchain, the better news is that finance is not the only area in which blockchain can be put to use. Food safety is among the many areas that can benefit in terrific ways from blockchain. A webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will explain how a basic invoice level blockchain can be used to build an integrated food safety system (IFFS) that requires supply chain players to meet contractual business and food safety requirements to establish a finance-based chain of custody systems.

John Ryan, who, for more than three decades has been an expert in the areas of manufacturing, food, transportation and the Internet, will be the speaker at this session on understanding blockchain as a means to resolve problems with Integrated Food Safety System (IFSS). Please www.compliance4all.com/ to enroll for this session and gain invaluable insights into how to put blockchain to use in the integrated food safety system.

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At this session, which is essentially about blockchain as a means to resolve problems with Integrated Food Safety System (IFSS), Dr. Ryan will explain to the participants the ways in which blockchain impacts the food industry and the extent to which food safety and quality inputs to the invoicing system could determine the financial aspects of a company in this domain.

He will describe the many concepts of this domain where blockchain could make a major impact, such as chain of custody, smart contracts, and Hyperledger. He will help participants understand how their business could get influenced by these concepts and how they can prepare to fulfill input requirements.

Dr. Ryan will also explain how inputs to blockchain will offer payers the opportunity to designate and comply with multiple contractual requirements at all stages of the food safety system, right from the farm through transportation, distribution, processing, packing and into customers. The ways in which blockchain works in all these sections will be described.

He will also show how blockchain can help lower risk levels and calculate probable supply chain failure points in the event of recalls, and how traceability in this technology can hasten a recall and limit its impact.

Dr. Ryan will cover the following areas at this session:

  • Understand Blockchain Basics (What is blockchain?)
  • Understand chain of custody
  • What are “smart contracts”
  • Understand “Hyperledger”
  • Find out who is using blockchain
  • Food Provenance as a new way of looking at food safety
  • Know how your company will be impacted
  • Prepare to fulfill input requirements
  • Understand Fraud prevention
  • Review what is in store for Integrated Food Safety Systems (IFSS)
  • Prepare your company to meet new traceability and supply chain requirements
  • Learn how your food safety data will be required to predict your potential for recall
  • See how blockchain fits into international and U.S. legal requirements
  • Understand the impact that blockchain and chain of custody will have on your business
  • Understand risk ranking and where your company fits in the supply chain.

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About the speaker: Dr. Ryan has worked and lived extensively throughout Asia and the U.S. at the corporate and facility levels for large and small companies as a turnaround specialist. He designed and piloted the US’ first RFID enabled farm to retail traceability system in the nation. His company, Ryan Systems, works with some of the world’s leading equipment, hardware, software, training and integration companies in the business.

He has published over forty papers on quality systems and has recently published a book for Elsevier Press entitled, Guide to Food Safety and Quality During Transportation: Controls, Standards and Practices. He previously published “The Quality Team Concept in Total Quality Control with the American Society for Quality.