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.

More about this https://t2m.io/haNOtnVV

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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.

Things You Need To Know About Cyber Security Incident Response Team Today

How to set up a foolproof and robust CSIRT that will help avert a cyberattack.

That cybersecurity is the most critical component for an organization is beyond debate. This goes without saying because attacks to any organization’s computer systems can happen at simply any time, at any location, and at any time of the day. This calls for them to be completely alert on a 24X7X365 basis.

A Cyber Security Incident Response Team (CSIRT) is indispensable for any organization, private or government, to ensure that valuable data is not breached. A system that is ready for cyberattacks 24X7 should consist primarily of a mechanism for both reporting incidents and disseminating incident-related information correctly.

A valuable webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will show how to set up a foolproof and robust CSIRT that will help avert a cyberattack.

At this webinar, which is being organized on July 23 and is of sixty minutes’ duration, Michael Redmond, Consultant, Speaker and Author, will be the speaker.

Please register for this webinar by visiting

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Most companies do set up a CSIRT, but one major issue with most of them is that the teams are not adequately trained to handle and test all aspects of the security issues. Both testing and training are necessary to create awareness among the teams, which will help them to respond to an attack or a potential one better. Both reporting incidents and disseminating incident-related information correctly is a must.

Personnel connected with cybersecurity, such as CISO, CSIO, CEO, Risk Managers and Auditors will gain enormous learning from this session, which will cover the following areas:

  • How often to test
  • Types of testing
  • Who should be involved
  • Scenario Development
  • Organizational process

About the speaker: Michael is the Chapter President for Association of Contingency Planners Eastern Great Lake Chapter and an active member of ISSA. She has consulted in the area of Cyber Security for clients in the arenas of Healthcare, Insurance, Financial and Manufacturing. She has been selected to speak on Cyber Security Incident Response and SIEM at various conferences.

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Unconventional Knowledge About Buying Or Selling A Business That You Can’t Learn From Books

Depending on who you are in the deal, you should be ready to negotiate, to do which you have to possess very sharp bargaining skills. Not all of these are taught in books.

Buying or selling a business is not the same as doing the same with consumer items. It requires a lot of thought and insight, and having to answer many questions about the business. The impact the merger or acquisition transaction has on the end result should be examined very carefully and critically. For instance, both the value of the business and the ROI will get impacted differently based on the whether the manner in which the transaction is recorded: as an investment or as an expense.

This is just one of the many aspects that need careful consideration when buying or selling a business. Although a lot can be learnt from books, conventional and grassroots wisdom is handier when it comes to handling these issues of high magnitude. Depending on who you are in the deal, you should be ready to negotiate, to do which you have to possess very sharp bargaining skills. Not all of these are taught in books.

A webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will show what skills need to be honed when it comes to buying or selling a business. The expert at this webinar, which is being organized on July 18, is Bart Basi, a highly experienced financial expert and academic. Please join us for this lively and meaningful session, which could go a long way in deciding the success of your business purchase, by registering at Unconventional Knowledge

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Dr. Basi will explain the financial. legal and tax implications of buying or selling a business. He will describe what ramifications need to be considered when allocating the resources of the transaction. This is all the more necessary and important to understand, as US tax code requires the parties to agree on what is being sold and what is being purchased, and determines the taxes paid by the seller based on the allocation agreed between the parties. This is just one of the many aspects of a business merger or acquisition transaction, whose knowledge can go a long way in ensuring that the financial, legal and tax elements of buying or selling a business are considered and complied with.

Both the parties need to also be aware of the consequences of the transaction. These could vary very highly based on whether the transaction is structured as an asset, stock, or a redemption transaction.

Dr. Basi will present actual cases to help the participants of this webinar get an understanding of the concepts. He will also describe the various issues facing both the buyer and the seller and explain the specific options available to each in a transaction under different situations.

At this session, Dr. Basi will cover the following areas:

  • Asset Transactions
  • Stock Transactions
  • Stock Redemptions
  • Stock Redemption Attribution Rules
  • Overview of IRC section 1202
  • Opportunity Zone Investments
  • IRC section 338(h) (10) election
  • Tax-free Reorganization
  • IRC section 1031 Exchanges
  • Personal Goodwill
  • Buy/Sell Agreements
  • Trusts

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About the expert: Dr. Basi’s expertise spans almost all areas of finance, such as financial accounting, business succession, business valuation, mergers and acquisitions, retirement and estate planning, strategic planning, and tax aspects of business decisions for closely held and family businesses.

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An Analysis Of PHARMACEUTICAL WATER SYSTEMS Strategies… Here’s What We Learned

They will also be able to understand how to build supporting data useful in pinpointing causes in situations where investigations are absolutely unavoidable.

Performing a water system excursion investigation and not being able to definitively conclude the root cause is one of the most frustrating experiences for a pharmaceutical company. Understandable although the situation is, it is important to bear in mind that this is avoidable. Most errors in a water system excursion investigation that ends up failing to help zero in on the exact root cause are manmade, and can be completely prevented, if the right steps are taken.

Most pharmaceutical organizations face this situation because they fail to see that all that they are required to incorporate are a few rational changes to their action “trigger values”, sampling and testing, all of which can be done even as they are still able to see real system problems with clarity when they do occur.

The result of doing an effective and accurate waters systems excursion investigation is vastly reduced cuts in resources costs, production downtime, product losses, and a host of other costs that can be invested prudently and productively.

Organizations that are serious about all these now have a wonderful opportunity to set their water system excursion investigation right and derive the correct values. A webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will show how.

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For this ninety-minute session, which is being organized on June 27, Compliance4All brings none lesser than the globally acclaimed honcho of pharmaceutical water systems, Teri C. Soli, President of Soli Pharma Solutions, Inc., as Speaker To enroll for this invaluable learning session, please log on to

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At this session, Dr. Soli will help participants understand how poorly designated trigger values, poorly designed use points, or poorly executed sampling or testing can lead to erroneous results with water system controls. He will help participants explore these possible causes and will provide effective alternatives that will help them to avoid most of their current redundant excursions. They will also be able to understand how to build supporting data useful in pinpointing causes in situations where investigations are absolutely unavoidable.

Dr. Soli will cover the following areas at this webinar:

  • What are excursions?
  • Water system dilemma: process control or quality control (utility or raw material), or both
  • Intended functions of Alert/Action Levels and Specifications
  • Investigation, necessary and often fruitless
  • Excursion responses and impact
  • Criticality of valves, hoses, & outlet flushing
  • Diagnosing the source of the problem
  • Minimizing unnecessary excursion responses through best practices

 

How to build a CULTURE of QUALITY into your Quality policy

Quality is not a simple, one-off exercise that is done in a haphazard manner. It is at the very heart of the product or the processes that go into it.

What is an organization that does not have quality at the heart of its business? It needs no Oracle to predict the demise of such an organization. Quality, defined in a simple manner as the ability of a product or service to meet its customer and process expectations in a defined and predictable manner, is truly the soul of a product or service.

Quality is something that needs to be built into the very culture of the organization

Quality is not a simple, one-off exercise that is done in a haphazard manner. It is at the very heart of the product or the processes that go into it. It should be inbuilt in each of the activities and should inhere into every stage of the production process. This can be brought about only when quality becomes an integral and inseparable part of the organization’s culture.

But then, how does one inculcate such a complex set of steps? This highly interesting and extremely valuable learning of how to build a culture of quality into your Quality Policy will be taught at a webinar that Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is organizing on April 24.

Suzanne Manz, an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma, will be the expert at this 60-minute webinar. Please visit https://www.compliance4all.com to enroll for this session.

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The importance of how to build a culture of quality into your Quality Policy becomes apparent when one considers that the business’ customers, its most crucial stakeholders, look for quality more than anything else. In products such as medical devices, the need for safety and effectiveness is paramount. On top of this, the medical device industry is highly regulated, which means that the regulatory agencies have very high quality expectations from organizations. The more diligently a medical device company complies with the set regulations in the field, the greater its chances of delivering quality products. At this webinar, Susanne will help participants understand the ways of balancing and meeting all of those expectations.

In the backdrop of scarce resources, it is impossible for a medical device business to survive unless it puts efficient and effective processes in place which will help it to achieve its quality goals in a cost-effective manner. The aim of this session is to inculcate the learning of how to create a culture of quality into the organization, which will help it to gain the competitive edge. And, there is no greater or better means to ensure customer satisfaction than a Quality Policy that is of high standards and is compliant with the regulatory requirements.

Quality at every stage cannot be accomplished unless the organization builds a culture of quality. This is the most essential and powerful means to putting an effective and efficient Quality Management System in place. A culture of quality does not happen overnight or by chance. It is something that organizations deliberate and chalk out purposefully and nurture and develop fastidiously.

This webinar will give an understanding of how to build a culture of quality into your Quality policy, Quality objectives, and into the very fabric of your Quality Management System. At this session, which is of high value to everyone involved in the organization’s Quality Policy in some or another way or at one or many steps, such as Quality Engineers, Compliance Specialists, Compliance Managers and Directors, Quality Managers and Directors, Consultants and Contractors, business leaders wishing to present a professional and compliant organization, cross-functional leaders wanting to make sure their organizations are well prepared, or anyone involved with an FDA or NB inspection, Susanne will cover the following areas:

  • FDA and NB expectations for Quality Systems
  • Lessons Learned from 483s and warning letters
  • How culture can impact quality and compliance risk
  • Management commitment and responsibility
  • Linkage to quality policy and objectives
  • Maturity levels to understand your culture of quality
  • Roles and responsibilities
  • The case for quality
  • Stages of quality and compliance culture
  • Tools and techniques for improvement
  • Best Practices.

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About the speaker: Black Belt, Master Black Belt, Regulatory Affairs Certification (RAC) and Certified Quality Auditor (CQA) Susanne Manz brings an extensive background in quality and compliance for medical devices, which spans all areas from new product development, to operations, to post-market activities. Her consulting business provides services to help medical device companies achieve world-class quality and compliance.

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.

 

Unheard Ways To Achieve Greater BIOANALYTICAL METHODS VALIDATION

These procedures are jointly called by a name: bioanalytical method validation.

How does a technician determine that a particular method used for quantitative measurement of analytes in a given biological matrix, such as blood, plasma, serum, or urine, is reliable and reproducible for the intended use? It is through various procedures that demonstrate these. These procedures are jointly called by a name: bioanalytical method validation.

It goes without saying that employing well-characterized and fully validated bioanalytical methods to yield reliable results which can be satisfactorily interpreted is absolutely essential to ensuring that the bioanalytical method validation is up to the mark.

What are the ways to achieve greater bioanalytical methods validation? These will be taught at a webinar that Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is organizing on April 17. Todd B. Graham, a clinical laboratory scientist for a large hospital system in the New York Tri-State Area, will be the speaker at this session. Please visit https://t2m.io/hFwt0V5E to enroll for this webinar and gain crucial learning on the ways to achieve greater bioanalytical methods validation.

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The essence of this webinar is a discussion of the best practices in the area of bioanalytical method validation, which include:

  • The components of a validation
  • The ways of including critical reagents comparison
  • Selectivity experiments
  • An assessment of stability
  • The concept of plate and experiment separation.

Also taken up for discussion will be the other areas of importance to the topic, namely, the importance of communication between the development and the validation labs, accuracy of transfer documents (SOPs). Predicate Rules, and support of clinical and nonclinical sample analysis.

At this webinar on the ways to achieve greater bioanalytical method validation, Todd will explain all the critical areas relating to the topic, such as:

  • A definition of a bioanalytical method
  • The steps necessary to validate an immunoassay
  • The challenges and opportunities of validating a molecular assay
  • The need for mass spectrophotometry assays
  • The likely issues that could come up in transitioning between assay classes, and
  • Best practices for all bioanalytical methods.

This session will cover areas such as:

  • FDA regulations and guidelines
  • Learning from the Crystal City FDA/Industry conference report
  • Phased approach for validation during drug development
  • Logistics of validation
  • Development of a master plan and SOP for validation
  • Preparation and use of reference standards and equipment
  • Defining parameters and acceptance limits
  • Defining validation experiments
  • Documenting and archiving raw and source data
  • Considerations for Microbiological and Ligand-binding Assays
  • Working with QC samples for quantitative results
  • To revalidate or not after method changes
  • Transferring and using the method to routine
  • Using computers for automated method validation
  • Documentation for the FDA and other agencies.

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About the speaker: As a clinical laboratory scientist, Todd Graham works as a scientific consultant for Fortune 500 biotechnology firms, healthcare systems throughout the world and R1 Research Level Universities.

He is a member of the Society for Laboratory Automation and Screening. He is also licensed as a Clinical Laboratory Technologist in New York State and is certified in Molecular Diagnostics by the American Society for Clinical Pathology.