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.

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.

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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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