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.

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.

FDA – Is Your cGMP Water System Ready for their Visit?

Documentation required to meet FDA Commissioning and Validation of Pharma Water Systems.

cGMP pharmaceutical water systems require specific Design, Documentation, Manufacturing, Installation, Testing, Commissioning, Start Up, Validation, Quality Testing and Extended Operation to become available for pharmaceutical manufacturing of products for sale.

Many steps and processes go into making cGMP water systems ready for their Assembly, Testing, Commissioning, Validation and Approval for cGMP use. Undoubtedly, implementing these steps properly requires previous experience and expertise in instrumentation and automation.

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A 90-minute webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will show how to obtain a proper pharmaceutical water systems cGMP that will help the water systems company face an FDA visit with confidence and pass its inspection.

Peter VIshton P.E., a senior an independent pharmaceutical water systems consultant who supports several companies with their water systems, will be the expert at this session. Please join the learning experience by logging on to

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At this webinar, Peter will explain what all items and procedures are required to accomplish items such as specific Design, Documentation, Manufacturing, Installation, Testing, Commissioning, Start Up, Validation, Quality Testing and Extended Operation, which will enable the pharmaceutical water system to be approved and placed in use. He will also familiarize participants with good practices for pharma water systems that will prevent problems.

If any of these items are missing or are not included and recorded in in GMP Water Systems Commissioning and Validation in a manner the FDA expects, it could delay its approval and use. For pharma water systems to avoid this scenario, it may sometimes become necessary to repeat the steps of the work and its documentation and adding explanations of how the work was done. All these iterations are sure to cost the organization more time and resources. Yet, the cost of noncompliance is inestimably higher than these.

At this session, the expert will show how to meet the FDA’s requirements and expectations and avoid getting penalized for noncompliance. He will cover the following areas:

  • Pharmaceutical Water Systems basics
  • Equipment that is commonly used to produce Purified Water and WFI
  • The Basic Regulatory Standards for chemistry and biological levels of Purified Water and WFI
  • The STEPS required to meet FDA Commissioning and Validation of Pharma Water Systems to assure Compliance
  • Documentation required to meet FDA Commissioning and Validation of Pharma Water Systems
  • Examples of potential PROBLEMS that can cause a System to not meet FDA Compliance
  • Dead Leg Rules
  • Compendial Action Levels of Purified Water
  • Sections of the ISPE “Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems” Good Practice Guide will be referenced
  • Methods to correct Pharma Water Systems Commissioning and Validation potential problem areas
  • Good Practices for Pharma Water Systems that will prevent problems
  • Pharma Water Systems practices that the FDA expects Pharmaceutical Water Systems potential impact to Regulatory drug manufacturing

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Implementing a GxP Quality Management System-Outrageous Ideas For Your GxP Quality Management System

An unsuccessfully implemented QMS not only dwindles the organization’s resources; it could take it further away from its Quality goals.

In a scenario of competitive markets, informed customers and rapidly changing business environments, organizations are realizing that Quality and Quality Management Systems (QMS) are an indispensable tool by which they can stay ahead. This is all the more pronounced when it comes to pharmaceutical companies, since their products are delivered directly to the human body.

The benefits of a clear and effective QMS are varied. They are proven, documented and quantifiable. The most prominent benefits a successful QMS brings about are the maximization of customer satisfaction, a lowering of costs, and an increase in agility. It fortifies an organization’s quality policy, objectives and core values at every level, and integrates iterative process improvement mechanism into it. This integration engenders alignment with FDA regulations and allows the organization to optimize its product and support processes.

QMS

A GxP QMS is a process whose implementation requires the competency, commitment, coordination and confidence of all production and support staff and management. Understanding some fundamental concepts, benefits and barriers will increase the likelihood of effective GxP QMS development and deployment, compliance with quality drivers and increased customer satisfaction.

A thorough understanding of these concepts will be imparted at a valuable webinar that Compliance4All, a leading provider of professional training, is organizing on July 26. William D. Fox, a quality management professional, will be the expert at this 90-minute session, which will impart Senior Managers, Managers & Supervisors, Process Owners, Departmental Heads, QA, QC and Continuous Improvement Managers & Staff, Quality Consultants, Regulatory and Compliance Managers, and Change Control/Documentation Staff with tremendous insights into all aspects of a GxP QMS.

Please visit to enroll for this session

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For an organization to implement a QMS, all its production and support staff and management need to have competency, commitment, coordination and confidence of everyone involved in it. The deeper their grasp of a few fundamental QMS design and implementation concepts, benefits and barriers; the greater the chances of an effective deployment.

Quality Management Systems vary across and within industries and organizations. Some of the parameters that go into making each organization’s QMS unique are Quality drivers such as industry standards, regulations and best practices. Each company can use these to create a tailored design and implementation strategy that implements the organization’s specific goals, processes and customers.

QMS is such a core part of an organization’s Quality Policy that it affects every aspect of the performance. An unsuccessfully implemented QMS not only dwindles the organization’s resources; it could take it further away from its Quality goals.

At this webinar, the participants will gain solid understanding of all these aspects of a QMS, which will reap for them all the benefits it brings. William will cover the following areas at this session:

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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

 

New National Bioengineered Food Disclosure Act (GMO Labeling)

The NBFDSA requires all foods containing bioengineered ingredients (BE) to be disclosed. Such foods must also meet recordkeeping and compliance requirements.

The United States Department of Agriculture (USDA) issued its long-awaited, new food labeling regulation known as the National Bioengineered Food Disclosure Standards Act (NBFDSA). This issuance has come up after the regulation was dogged in controversy for many years. This new rule, which was highly anticipated by industry, is expected to offer clarity on several long-standing GMO questions relating to the financial and risk impact to businesses, and help consumers make well-informed, educated, and science based food choices.

Being a federal standard, the NBFDSA offers a leveling the playing field for industry and aids consumers who are often confused on GMO or non-GMO product labels.

Want to know all about this regulation? A webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will explain everything that the industry needs to know on launching the NBFDSA.

Gina Reo, President, Quality Assurance Strategies, LLC, will be the expert at this session. Please visit to enroll for this valuable session.

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The NBFDSA requires all foods containing bioengineered ingredients (BE) to be disclosed. Such foods must also meet recordkeeping and compliance requirements. At this session, Gina will explain the definitions of foods subject to the ruling, exclusions, responsible parties, mandatory disclosure options and recordkeeping and implementation dates, and clear confusions relating to them.

She will cover the following areas at this session:

  • Background on US GMO (Genetically Modified Organism) Labeling
  • Basics of the National Bioengineered Food Disclosure Rule (National Bioengineered Food Disclosure Standards Act)
  • Ingredients Subject to Disclosure
  • Labeling Disclosure
  • GMO Disclosure Symbols
  • Thresholds and Exemptions
  • Compliance Timelines for Implementation
  • Insights & Success Takeaways

A large swathe of professionals who work in these areas are expected to derive wholesome benefit from this learning session. Quality Control/Assurance and Food Safety Professionals, Supervisors, Leads, Managers, Operations Managers/Supervisors, Sanitation Managers, Supervisors or Leads, Corporate Quality Managers, Operations Personnel, Senior Management, Plant Management Personnel, Third Parties Developing HACCP Plans, Auditors and those with Food Safety Inspection Roles, Validation Specialists, Consultants, Quality system Auditors, and PCQI’s are among them.

https://t2m.io/68m4Wkch

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.