Remember Your STATISTICAL METHODS Lesson? I’ve Got Some Tips…

The ways by which organizations can optimize their various data to enhance decision-making are vital for any organization.

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Well, most organizations are experts at churning out mountain loads of data. They can produce data at the drop of a hat on any area of their work. But the crucial question is, how useful is this data? Are organizations using the right methods by which they can turn this data into useful and actionable information?

This is a core question for an organization. It is because the key to optimizing their operations and making effective decisions that help achieve a competitive advantage lies in the organizations’ and individuals’ ability to put the available data to the best possible use.

Obviously, organizations that don’t properly leverage data are bound to trail behind those who do. The ways by which organizations can optimize their various data to enhance decision-making are vital for any organization.

This knowledge will be imparted at a webinar that is being organized on March 20 by Compliance4All, a leading provider of professional training for all the areas of regulatory compliance. At this session, Steven Wachs, a senior statistician, will explain how to bring about a turnaround in organizational thinking when it comes to making use of data. Please visit https://t2m.io/cRPp46Py

Statistical Analysis

The aim of this webinar is to introduce participants to important statistical concepts and methods that are essential for making objective decisions related to product quality. A grasp of these concepts helps organizations to arrive at objective decisions to ensure and improve product quality. The methods he will introduce will open the participants’ perspectives to a host of critical lines of thinking, which include:

  • Determining how well the process/product meets requirements
  • Knowing when a process or system is behaving consistently or differently than before
  • Uncovering which key inputs to the process affect product performance or customer satisfaction
  • Ensuring that what needs to be done can be effectively measured
  • Comparing groups of data when a random (natural) variation is present
  • Predicting future outcomes using a predictive model

Steven will introduce a host of methods relating to statistical methods, which include:

  • Statistical Process Control
  • Process Capability Assessment
  • Regression Modeling
  • Design of Experiments
  • Hypothesis Testing
  • Measurement Systems Assessment.

Some of the methods whose purpose the participants of this webinar will gain an understanding of include:

  • Statistical Process Control
  • Process Capability Assessment
  • Regression Modeling
  • Design of Experiments
  • Hypothesis Testing
  • Measurement Systems Assessment.

Steven will cover the following areas at this webinar:

  • Variation & Quality
  • Process Stability/Statistical Process Control
  • Process Capability Assessment
  • Predictive Models (Regression & Design of Experiments)
  • Hypothesis Testing for Decision Making
  • Measurement Systems Assessment
  • Examples & Applications.

This webinar is aimed at benefiting personnel in various positions in the field of statistics, and these include:

  • Quality Personnel
  • Manufacturing Personnel
  • Operations/Production Managers
  • Production Supervisors
  • Supplier Quality personnel
  • Quality Engineering
  • Quality Assurance Managers, Engineers
  • Process or Manufacturing Engineers or Managers.

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About the speaker:

During his over 25 years of wide-ranging industry experience in both technical and management positions, Steven has worked in most areas of statistical applications in reputable organizations. He possesses expertise in the application of reliability methods to achieve robust and reliable products as well as estimate and reduce warranty.

In his current role of being Principal Statistician at Integral Concepts, Inc., he assists manufacturers in the application of statistical methods to reduce variation and improve quality and productivity. Steven regularly speaks at industry conferences and provides workshops in industrial statistical methods worldwide.

New Easy Ways to Learn Everything About Quality by DESIGN PROGRAM

Quality risk management and product process control are core components of QbD.

Quality by Design (QbD) is a Quality approach that relates to the ability of a pharma product to meet its quality requirements. In order to understand this concept, we need to first get a simple understanding of the meaning of quality in the context of the pharmaceutical industry. It means the ability of the pharmaceutical product to consistently deliver a pharma product that is free of contamination and meets the expectations of the consumer by offering the therapeutic value as defined in the product’s label. This has to be assured through a set of reproducible methods. The most common among these are in vivo and in-vitro methods.

QbD is a systematic approach to the process of ensuring quality in the pharmaceutical product. It seeks to meet predefined quality goals and objectives by employing the methods used in sound science. Quality risk management and product process control are core components of QbD. These are some of the goals that pharmaceutical QbD seeks to achieve:

  • Meaningful product quality specifications that are built on the foundation of clinical performance
  • Boosting the design, understanding, and control of the product and process with the aim of increasing process capability and reducing product variability and defects
  • Augmenting the efficiencies of product development and manufacturing
  • Bettering root cause analysis and post approval change management.

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QbD professional seek to achieve these goals through a twofold approach by which they:

  • Link the product quality to the desired clinical performance
  • Design a vigorous process of formulation and manufacture, which makes it possible for them to deliver the product with the desired product quality, consistently.

Now, new easy ways to learn everything about Quality by Design program

Applying the principles of a QbD approach can benefit the pharmaceutical companies immensely. By implementing these principles, they can bring about a measurable improvement in their manufacturing efficiency and can promote innovation. Yet, implementing these principles into the pharmaceutical development culture can be challenging for an organization, since QbD involves a complex set of interactions, technologies and systems that are not easy to grasp.

All these seemingly complex concepts need not befuddle you. Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is organizing a webinar on the topic of new easy ways to learn everything about Quality by Design program. Compliance4All brings the highly experienced Quality professional, Steven Laurenz, as speaker of this valuable, hour-long session.

Please visit https://t2m.io/ffxwM3Ha to enroll for this highly meaningful learning on how to initiate and maintain a healthy QbD program that satisfies the requirement set out by the regulations in this field.

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The core of this training session is the understanding Steven will give of all the aspects of QbD, such as what it means, what benefits your organization can gain by applying a QbD approach, and what tools can be employed to implement a sound QbD approach. He will offer key steps for achieving this.

Core topics concerning QbD, such as the target product quality profile, risk assessment, methods to establish a design space, and design of a control strategy will be covered. The aim of offering an understanding of these topics is to help bridge the gap between understanding the principles and applying them practically.

This session is of immense use to those who are involved in the QbD process, and these include Process Owners, Quality Auditors, Quality Engineers, Quality Professionals, Production Engineers, Production Supervisors, Senior Quality Managers, Regulatory Professionals, Manufacturing Engineers, Compliance Professionals, Development Professionals, and Senior Development Managers.

At this webinar, Steven will cover the following areas:

  • Using Models
  • Risk Assessment
  • Control Strategy
  • Design of Experiments
  • FMEA and Control Plan
  • Developing a Design Space
  • Target Operational Profile
  • Process Analytical Technology (PAT)
  • Quality Target Product Profile (QTPP).

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About the speaker: Steven Laurenz brings a quarter of a century of experience in technical leadership, which has included areas such as product development, process development, technology transfer, and process optimization.

Steven is skilled in taking new products from early laboratory stage to successful manufacturing launch and is an expert in integrating Quality by Design and risk management into product development.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4070262/

https://learnaboutgmp.com/good-validation-practices/pharmaceutical-quality-by-design-qbd-an-introduction-process-development-and-applications/

Design Verification and CAPA Effectiveness Checks [Plans for Process] Validation

How to identify when sampling plans for other properties are required for things like precision, accuracy, homogeneity and failure rates.

This is designed to help you select sampling sizes and acceptance criteria for one-time studies like process validation, design verification, component qualifications and CAPA effectiveness checks including:

  • How to link risk with the confidence statements associated with the sampling plans
  • Identify a variety of sampling plans, that all make the desired confidence statements
  • Select from among these sampling plans that plan which offers the best balance between the number of units tested and the risk of failing the validation
  • How to identify when sampling plans for other properties are required for things like precision, accuracy, homogeneity and failure rates

Approaches and sources of such plans are explained and contrasted with manufacturing sampling plans.
Ensure compliance when selecting sample sizes.
Learn strategies for reducing sample sizes.
Learn strategies for avoiding false rejections.

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  • Claims that can be made when passing a sampling plan
  • How to select a sampling plan to make a specific claim
  • Different types of sampling plans including single, double and variables
  • How to reduce the number of units tested
  • How to increase the chances of a good product/process passing a validation
  • How to write protocols to handle contingencies so to avoid deviations
  • Practical considerations including selecting representative samples

Sampling Plan Analyzer and Distribution Analyzer software packages as well as providing consulting and training on Statistics including Robust Design, Tolerance Analysis, Design of Experiments, Trending and Acceptance Sampling.

Webinar from Compliance4All on January 9, 2019 on Supervising a Human Error Free Environment

The tools that the speaker will offer at this course can be used for implementation immediately.

Fremont, CA: Compliance4All, a leading provider of professional training for all areas of regulatory compliance, is organizing a webinar on January 9, 2019. The topic of the webinar is “Supervising a Human Error Free Environment: You can do a Lot More than you Think”, and the speaker is Ginette Collazo, an Industrial-Organizational Psychologist.

To enroll for this webinar, please visit https://www.compliance4all.com/control/w_product/~product_id=502284LIVE

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In many industries, despite the many advances that have shaped safety standards, human error is still a factor to be reckoned with seriously. Human error, despite taking what one thinks are the best precautions, can lead to loss of quality, processes and production, not to mention the financial one.

What is needed is a comprehensive approach to elimination of human error. While it is acknowledged that human error can never be eliminated, one can take care from many angles and perspectives to minimize it. This should start at the design stage. Good Manufacturing Practices (GMP) regulations need to be implemented in complete faith. The approach should be to identify the root of the human error first and then take the necessary steps to address them.

These should be done in complete sync and harmony with the concerned staff members in charge of safety and in accordance with the principles of GMP. The specific methodologies needed for implementing these will be the essence of the learning this 90-minute webinar will impart.

The speaker will explain strategies with which the unit can use a specific methodology with which to sync and approach issues in GMP related environments that uses a method for correcting, preventing and avoiding recurrence of these issues. She will also describe the practical approaches that can be adhered to while supervising on the floor.

She will also drive home the importance of supervision in reducing and preventing human error and show ways by which to implement metrics that can help track and measure human error rates. The five elements of ensuring a human error-free environment will be discussed at this webinar. The tools that the speaker will offer at this course can be used for implementation immediately.

This webinar will serve the following learning objectives:

  • Understand human error: factors and causes
  • Understand the importance of supervision in creating a high reliable group for both regulatory and business compliance
  • Discuss issues related to supervision and how to avoid traps that will allow errors to occur
  • Identify Root Causes and CAPA associated to supervision.
  • Learn how to measure human error rates at your department and keep track of metrics
  • Identify what I can do to support human reliability at the site.

This course will be beneficial to Supervisors, Managers and Directors, Operations, Manufacturing, Plant Engineering, QA/QC Staff, Process Excellence/Improvement Professionals, Industrial/Process Engineers, Compliance Officers, Regulatory/Legislative Affairs Professionals, and General/Corporate Counsel.

About the speaker:

Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines that study the interaction between human behavior and productivity. She has held positions leading training and human reliability programs in the Pharmaceutical and Medical Device Manufacturing Industry.

Pump Up Your Sales with Some Remarkable Lean Management Tactics

Spending a few productive minutes with HR is likely to save you valuable time on three or four unproductive interviews running into hours.

Lean management for sales? Isn’t that kind of oxymoronic? We have been told all along that lean management is ideal for areas such as manufacturing, services, operations and supply chain since it is essentially built upon minimalization of waste. How does sales fit into this picture?

Fact is, it does. You can pump up your sales with some remarkable lean management tactics. As we know, lean management is a set of practices that helps an organization to optimize its revenues while keeping its resources at a minimum by avoiding wastage at every possible point. Lean management is primarily about creating value by identifying the core points at which wastage occurs and plugging them in every viable way.

Lean management consists of streamlining and harmonizing the points of productivity across the areas of service, technology, manufacturing and many others. Now, this understanding is necessary to derive a grasp of how you can pump up your sales with these remarkable lean management tactics. So, what is in all this for sales is a question some people might ask, in just the way many others have. They ask, with quite some justification, if lean management can work in an area that offers sales incentives to its staff to reward and motivate them.

How does lean management work for sales?

Let us try to understand how lean management concepts go for sales:

The starting point, in fact the real point, to how to pump up your sales with some remarkable lean management tactics is to realize that inculcating activities in which waste does not occur is not restricted to areas with which lean has come to be identified. Simple: you can adapt lean principles into all the areas of sales starting from interviewing candidates for the job.

Let me explain: when you shortlist candidates for interviewing to be brought into the sales team, whether you realize it or not, the organization spends a lot of unnecessary resources on arranging the interview. These could range from calling up the candidate, spending time on the interview and deciding about her suitability. What if the candidate is rejected? Haven’t you wasted a lot in terms of resources? Haven’t you wasted your manager’s time, the expense on phoning or any other such items?

Adapt the same lean thinking for sales as well

Pumping up your sales with some remarkable lean management tactics consists of looking at all these as wasteful activities. Well, you may be wondering if I am saying that interviewing candidates is a wasteful activity. It certainly isn’t. But spending a lot of time and money on interviewing the wrong candidate certainly is!

If you keep the lean principles in mind, you would ask HR to shortlist a more suitable candidate, where the chances of rejecting are fewer, and you could be doing with a lot less waste of your time. Spending a few productive minutes with HR is likely to save you valuable time on three or four unproductive interviews running into hours.

And what about lean practices during the sales itself? Setting up the right time for the sales appointment, avoiding travel on a call that is not likely to result in a deal, avoiding expensive trips…there are umpteen ways by which you can pump up your sales with some remarkable lean management tactics.

Lean management in creating value for the customer

And, there is another very core aspect of lean management for sales, which will help you pump up your sales with some remarkable lean management tactics. Creating value for the customer is what a business essentially exists for, right? When this is done by applying lean management principles, there is a tremendous boost to the value the customer gets from the company’s products or service. One way of accomplishing this is by integrating sales with the entire processes the company has.

Integrating sales with the other processes ensures that sales becomes part of the operations to the extent that operations are designed and implemented keeping sales in mind and not in isolation of it. Bringing this vital element into the processes rounds up the whole cycle and enhances the value chain on an unimaginable scale.

The direct offshoot of such an integration is that when the customer sees value in the company’s products or services, there are fewer complaints or recalls. This is the finest means of augmenting the company’s resources because the fewer these items, the more it can leverage its resources for further improvement.

In this way, many such activities round sales can be minimized. These count for lean practices, although it must be said that these lean principles have not been designed keeping sales in mind. That however, does not take away from the relevance or value of lean principles to sales.

https://www.lean.org/WhatsLean/

https://www.cmtc.com/blog/5-lean-strategies-for-your-sales-marketing-teams

https://www.leancompetency.org/wp-content/uploads/2015/11/Applying-lean-in-sales-and-marketing-2015.2.pdf

http://customerthink.com/what-sales-can-learn-from-lean-manufacturing/

You will get Great Results from your Data with Excel PowerPivot and PowerQuery

Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data.

If you work with data, you’re likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources. Luckily there are two Microsoft tools- PowerPivot and PowerQuery-that solve ALL of these issues, right inside Excel.

In today’s world, there is tons of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data.

For more advanced topics these all areas will be covered:
Learn about Data Models
Creating Relationships between Different Datasets in PowerPivot
Importing Data into Excel from an Array of External Sources
Learn about DAX formulas
Cleaning,Transforming and Merging Data with PowerQuery (goodbye,Access)
Linking Data Sources
Making Reports from Multiple Data Sources

benefits-of-excel-training

For these professionals it is more useful:
Managers of all Levels
Anybody who uses Excel on a Regular Basis, and want to be more Efficient and Productive
Administrators
Salespeople
Trainers
Bankers
Office Workers

How 6 Things Will Change The Way [You Approach] Construction Education

A current approach that has been taking root is what is called the Integrated Project Delivery (IPD).

The construction industry is in a state of flux. Newer technologies have been emerging in the backdrop of a dichotomous situation in which the world is witnessing a boom in construction. As pioneering technologies establish themselves in the field, the development leads to novel approaches. These approaches are the result of active collaboration between the industry and the academia. A current approach that has been taking root is what is called the Integrated Project Delivery (IPD).

The IPD approach to construction industry education has evolved from the explosion in the construction industry in various parts of the globe-albeit lopsided-and with it, the realization that the traditional approach of having a master builder for completion of a project has outlived its utility. This is because the activities involved in construction have undergone such a multitudinous expansion that it is no longer possible or practical for one single master builder to oversee the complete range of construction activities across the project.

The nature of such an expansive gamut of activities calls for collaboration across the tripod of disciplines consisting of architecture, engineering and construction. The effectiveness of this approach is best inculcated into future professionals when they are still students. Based on the realization that this combination is missing from the curricula of most educational institutions, present-day academia is moving towards crafting educational syllabi that integrate the three disciplines.

This interaction is best built at the stage of learning. This lays the durable foundation they need to make successful careers in construction in the latter part of their lives. The aim of the IPD approach to construction education is to integrate the best of these three disciplines and amalgamate the essentials of each of these into the syllabi, so that nothing is left out and that these are not learnt in isolation and to the exclusion of each other.

The IPD approach to construction education

The IPD approach to construction education is based on the understanding that the disciplines of architecture, engineering and construction should be ingrained in tandem with each other into students. The belief is that when this happens, the learning will be able to help the student derive the full benefit of these disciples along with that of the Building Information Modeling (BIM).

Never miss these things will change everything https://goo.gl/7k4pBu