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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How creators of “true detective” would uncover the story of MS Excel sensitivity tools

Using Data Tables with one or two-inputs to deliver an array of outcomes from your model in just seconds.

Microsoft Excel is a complete utility program, and most people who use it are aware of the many wonders it is capable of doing. Calculation, effects, drop and place and so on are some of the features that make it very efficient for users. But did you also know that it is very effective in also helping to make business forecasts?

Or, did you know that functions like Scroll Bars, Goal Seek, Data Tables, and Scenario Manager can enhance the power of your financial programs and take your ability to perform with these to exceptional heights?

You can learn all the functions of the wonderful program that MS Excel is, from a webinar that is being organized by Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, on September 19.

Miles Hutchinson, who is a highly experienced, senior Finance professional, will explain these and other functions of MS Excel at this webinar. To gain thorough knowledge of how to put this program to optimal use in helping to make forecasts and other functions, please register by visiting https://www.compliance4all.com/control/w_product/~product_id=502703LIVE

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Miles will explain the best practices for designing efficient forecasting models. He will also give a proper learning of how to apply Scroll Bars, Goal Seek, Data Tables, and Scenario Manager. All this learning, which can be had in just 90 minutes, can be applied over a lifetime.

He will cover the following areas at this session, which is aimed at the benefit of professionals who use the MS Excel program for their financial areas, such as Financial Analysts, Business Analysts, Information Reporting Officers, Tax Managers, Compliance Officers, Compliance Managers, CFO’s, Controllers, Accounting Managers, Auditors, and Risk Managers:

  • 20 rules of effective model design
  • Applying Scroll Bars to individual cells to flex them over their relative ranges with the touch of your mouse
  • Using Goal Seek to discover how much a single variable must move to reach a desired outcome
  • Using Data Tables with one or two-inputs to deliver an array of outcomes from your model in just seconds

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About the speaker: Miles Hutchinson has been an auditor with PriceWaterhouseCooper and the Chief Financial Officer of a $1 billion real estate development company. He is a highly sought after professional speaker and consultant who has presented over 1000 seminars and training sessions on a myriad of business and financial topics, such as financial analysis and modeling, accounting matters, strategic planning, and compliance with the Sarbanes-Oxley Act.

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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/

Facts about deviation investigations everyone should know

Having a procedure on Deviation Investigations isn’t enough. it’s the content and conclusions of the investigations themselves that really count.

Focus on how to avoid the pitfalls that may occur during FDA inspections and help eliminate 483 observations. Learn how to identify and avoid potential pitfalls during deviation investigations.

One of the foremost common authority 483 and Warning Letter citations continues to be inadequate investigations. The authority uses the investigation reports and investigation trends to spot potential quality issues altogether areas of the corporate. Ultimately, inadequate investigations will result in 483 citations, Warning Letters, unharness of sub-standard product, or product recall. what is more, pricey and long system rectification is also needed.

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Having a procedure on Deviation Investigations isn’t enough. it’s the content and conclusions of the investigations themselves that really count. Doing a correct root cause analysis, gathering proof and guaranteeing a property corrective action is vital to a correct deviation investigation.

This Session can facilitate attendees perceive the elemental investigation steps and ability sets. Key focus are placed on identification and initial news of deviations, fact/evidence gathering, and incoming at the right root cause and CAPA. The importance of investigation coming up with, vital thinking skills and effective preventative action plans will be mentioned.

Who will be benefit:

  • Deviation Investigators
  • Reviewers and Approvers of Deviation Investigations
  • QA Staff and Management
  • Regulatory Affairs Staff and Management
  • QC staff and Management
  • Compliance Auditors

About the Instructor:

Danielle DeLucy MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 17 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations.

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Gowning and ways to Avoid the common Sources of Contamination

In sterile combination, antiseptic technique is tributary to the bar of microbiological contamination. it’s providing sterility, safety, and effectivity to the sterile product, particularly varied injections for patients. Cleaning, Gowning and correct strategies of contamination management are reviewed along side why clean rooms square measure designed the manner they’re.

Why you have to Know:

Compounding sterile merchandise square measure created utilizing antiseptic technique. antiseptic technique could be a microbiological term concerning the interference of being contamination. The procedure involves the utilization of specialised instrumentation, sterile attire, meticulous process, and continuous improvement.

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This course can review correct improvement, gowning and ways in which to avoid the common sources of contamination that exist in an exceedingly room setting. This course is additionally a decent refresher for those personnel that ar accustomed to the thanks to properly add the room and why clean rooms ar designed for correct contamination management.

Register here for deep study

Who will be benefit from this:

  • This course will benefit those Aseptic operators, Aseptic sample handlers, personnel who work in a Biological Safety Cabinet (BSC) and their management and Quality Assurance counterparts, in highlighting how to operate in a clean room environment, proper facility design, proper personnel gowning, and the equipment needed to conduct environmental monitoring
  • In addition, this course will review how Quality Systems help define requirements for aseptic technique and clean rooms and how to properly maintain these environments

About the Instructor:

Danielle DeLucy MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 17 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations.