Data visualization can have a great effect on statistical presentations

Data visualization 2

It is said that a picture is worth a thousand words. This adage may appear figurative and allegorical when applied to the realm of statistics, but there is no denying the fact that a visual approach to statistics enlivens the subject like no other. A dash of pictorial work and some coloring at the right places enhance the presentation of otherwise drab statistical figures and slides dramatically.

Graphic displays illustrate the facts and truths behind statistics very artistically. They augment the appeal of what is conveyed by the statistical figures without altering or diluting the effect or the content. This is why presenting data visually is a great enhancer. It is very useful in any compliance analytics workflow.

Graphic enhancements can be used to uplift and raise the presentational aspects of statistics, but it requires skill and specific tools, because the pictorial aspect has to fit rightly into the statistical presentations. Any mismatch or mix-ups can have the opposite effect, making the statistical pictures gaudy, out of place and jarring.

Get to the ways of doing it

Data visualization 5

A two-day seminar from GlobalCompliancePanel, a highly respected provider of professional trainings for the regulatory areas, will offer thorough and complete learning on the proper ways of beautifying statistical presentations with the right mix of graphics, so that the intended purpose of embellishing is met.

James Wisnowski, who is the cofounder of Adsurgo LLC and co-author of the book, Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP and currently provides training and consulting services to industry and government in Design of Experiments (DOE), Reliability Engineering, Data Visualization, Predictive Analytics, and Text Mining; will be the Director at this two-day seminar.

Please visit Data visualization can have a great effect on statistical presentations  to enroll for this highly interesting seminar, which has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

All about graphics in statistics

Data visualization 4

This seminar on data visualization will present methods using which participants can interactively discover relationships graphically. James will offer participants the foundations that will help them create better graphical information with which to accelerate the insight discovery process and improve the comprehension of reported results.

He will lead participants to an exploration of the first principles and the “human as part of the system” aspects of information visualization from multiple leading sources such as Harvard Business Review, Edward Tufte, and Stephen Few. All this will be done using representative example data sets. Best practices for graphical excellence to most effectively, clearly, and efficiently communicate a thought will be explained. He will show how to construct visualizations for univariate, multivariate, time-dependent, and geographical data. Participants are encouraged to bring laptops to follow along demonstrations in JMP (free trial download at www.jmp.com), and open source solutions such as R (https://www.r-project.org) and Tableau Public (https://public.tableau.com/s/).

Meeting the requirements of analytic solutions

Data visualization 3

As all regulated industries have now come to expect data-driven decisions; compliance regulations require analytic solutions. The starting point of these solutions is the development of data visualization for discovering relationships and finish with crisp graphs communicating results. To take the example of 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries; these documents specify the application of statistical methods for the following:

For each of these areas, data visualization serves as the foundation. Data visualization plays a major role in varying degrees in varied areas such as:

  • meeting FDA analytical requirements for third-tier critical to quality attributes for analytical bio similarity evaluations where graphical plots and tables alone may sufficiently address compliance criteria

 

  • HIPAA compliance, risk management and analysis, and many others of the quality functions.

James will show how to use data visualization and optimize the effect of these areas. The following agendas will be part of the two-day presentation:

  • Introduction and definitions
  • Examples of data visualizations for compliance and regulated industries
  • Historical context
  • Characteristics of data
  • Interactive data visualization exploration with Excel and websites
  • Human side of data visualization
  • Principles of good graphic design
  • Data visualization methodology
  • Best practices
  • Software introduction: JMP
  • Univariate plots
  • Distributions and histograms
  • Pie graphs, violin plots, pareto plots, box plots
  • Conditional formatting
  • Mulitvariate plots and heatmaps
  • Correlation
  • Multivariate scatterplots and density graphs
  • Contour plots
  • Categorical data plots: treemaps, mosaic plots
  • Software introduction: R
  • Software introduction: Tableau Public
  • Univariate plots with R and Tableau
  • Multivariate plots with R and Tableau
  • Dynamic and interactive graphs
  • Brushing, dynamic linking, and filtering
  • Profilers on response variables and optimization
  • Time series plots
  • Waterfall plots
  • Sparklines and trend lines
  • Statistical Process Control charts
  • Maps
  • Text data visualization
  • Dashboards
  • Course summary.

 

Seminar Calendar of Upcoming Courses – June to July – 2017

Upcoming-Courses-for-French-Circles-Club

GlobalCompliancePanel’s seminars are a wonderful opportunity for professionals in the regulatory compliance areas to understand the latest happenings and updates in the regulatory compliance areas and to implement them, something they need to climb in their professions. GlobalCompliancePanel brings together a few of the best recognized names in the field of regulatory compliance on its panel of experts. The result: Learning that is effective, valuable and helpful.

GlobalCompliancePanel’s experts help you unravel all the knowledge you need in all the areas of regulatory compliance. At these seminars which are held all over the globe, you get to interact with them in person, so that any doubt or clarification you have is sorted out by none other than the honcho. They help professionals like you implement the regulations and stay updated, so that regulatory compliance causes no stress for you.

GlobalCompliancePanel’s experts offer their insightful analysis into the issues that are of consequence to regulatory professionals in their daily work. Their thoughts help you implement the best practices of the industry into your work. They also offer updates on the latest regulatory requirements arising out of a host of the laws and issues related to regulatory compliance, including, but not limited to medical devices, food and beverages, pharmaceuticals, life sciences, biotechnology and pharmaceutical water systems.

Take a look at our upcoming webinars from GlobalCompliancePanel, which will put you on the road to learning about any area that is of importance to your profession. You can plan your learning from GlobalCompliancePanel by looking at our seminars in the next few weeks at locations of convenience to you. You can choose from a whole range of topics. See which among these trainings suit you: Design of Experiments (DOE) for Process Development and Validation, Writing and implementing effective SOP’s, new FSMA rules, risk management and device regulations, data integrity, combination products, and what have you!

Contact us today!
NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
Toll free: +1-800-447-9407
FAX : 302 288 6884
Website: http://bit.ly/Courses-June-to-July-2017

Article on “Statistical Sampling Plans for Medical Devices”

One of the important aspects of design control of medical devices is statistical sampling plans for medical devices. To gain an understanding of the idea of statistical sampling plans for medical devices, one needs to understand the process of medical device design controls.

Statistical sampling plans for medical devices needs to be seen in this background: Under Sec. 820.30 of Title 21 of Code of Federal Regulations (CRF) the FDA sets out requirements from medical device manufacturers -which want to market certain categories of medical devices in the US -for establishing and maintaining procedures to implements design controls into the device.

An understanding of design controls is necessary first

First of all, what are design controls? Design controls are linearly and logically described and recommended steps that manufacturers have to take for ensuring that they have developed what they meant to develop. In addition, design controls have to also be implemented to ensure that the final product is in line with the expectations and needs from the customer’s perspective.

Statistical sampling plans for medical devices come at a slightly later stage. Design controls pave way for the validation processes of design verification and design, which are done to ensure that the device design has met critical specifications or outputs and fulfill the requirements for the safety requirements, intended use, or specified application.

Verification and validation

This stage makes way for the next, which is fulfillment of design verification and validation (V&V), as required under Sec. 820.50 of 21 CFR. A core part of this code is the requirement from manufacturers for establishing and maintaining procedures to locate valid and proper statistical techniques for the process capability and product characteristics to be considered applicable. These are what constitute statistical sampling plans for medical devices

More of rule of thumb

Statistical sampling plans for medical devices need to be written and based on a well-established statistical foundation. However, the FDA does not prescribe a formal plan for writing down statistical sampling plans for medical devices. These are to be based more on rule of thumb. In other words, there are no acceptable limits violations under statistical sampling plans for medical devices. The statistical sampling plans for medical devices need to be implemented on a case-to-case basis, based on the device’s characteristics and features.

In arriving at statistical sampling plans for medical devices, the FDA sets out the following rule:

Table 1

Binomial Staged Sampling Plans

Binomial Confidence Levels

able 2

Binomial Staged Sampling Plans

Binomial Confidence Levels

ucl = Upper Confidence Level

These constitute the core guidance for statistical sampling plans for medical devices.

Learn more on this topic by visiting: Article on “Statistical Sampling Plans for Medical Devices”

Applied Statistics for FDA Process Validation

The pharmaceutical industry considers Applied Statistics for FDA Process Validation to be of very high importance. In 2011, the FDA set out this guidance for the industry. as part of this guidance, called “Process Validation: General Principles and Practices”, which sets the framework for Process Validation in the pharmaceutical industry, any organization in the pharmaceutical industry has to set up a three-stage process.

These are the three stages:

I.           Process Design

II.           Process Qualification, and

III.           Continued Process Verification.

Stage 1, or what is called the Process Design stage, is the stage in which the commercial manufacturing process is defined. This definition is based on knowledge gained through development and scale-up activities.

Stage 2, called the Process Qualification, is the stage in which an evaluation is made of the process design to determine if the process is capable of reproducible commercial manufacturing.

Stage 3, the Continued Process Verification, is meant for giving ongoing assurance during routine production to ensure that the process remains in a state of control.

A seminar on the ways implementing Applied Statistics for FDA Process Validation

GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will be organizing a two-day seminar in which the ways of using Applied Statistics for FDA Process Validation will be taught. Richard Burdick, Emeritus Professor of Statistics, Arizona State University (ASU) and former Quality Engineering Director for Amgen, Inc., will be the Director of this seminar on applied statistics for FDA Process Validation.

In order to learn Applied Statistics for FDA Process Validation in-depth, please register by visiting Applied Statistics for FDA Process Validation. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A detailed and methodical approach to implementing statistical methodologies

This two-day course on Applied Statistics for FDA Process Validation will focus on the ways by which a systematic approach to implementing statistical methodologies into a process validation program consistent with the FDA guidance can be established.

Beginning with a primer on statistics, Dr. Burdick will explain how the methods of Applied Statistics for FDA Process Validation seminar can be applied in each remaining chapter.

Dr. Burdick will next move on to explaining the two fundamental requirements for Process Validation, namely the application of statistics for setting specifications and assessing measurement systems (assays).

He well then show how to apply statistics through the three stages of process validation as defined by requirements in the process validation regulatory guidance documents.

Given that the methods taught through all these three stages are recommended by regulatory guidance documents; this seminar on Applied Statistics for FDA Process Validation will provide references to the specific citations in the guidance documents.

This seminar on Applied Statistics for FDA Process Validation will lead participants into ways of establishing a systematic approach to implementing statistical methodologies into a process development and validation program that is consistent with the FDA guidance.

All-round learning related to Applied Statistics for FDA Process Validation

Dr. Burdick will teach participants how to:

o  Apply statistics for setting specifications

o  Assess measurement systems (assays)

o  Use Design of Experiments (DOE)

o  Develop a control plan as part of a risk management strategy, and

o  Ensure process control/capability.

All concepts at this Applied Statistics for FDA Process Validation seminar are taught within the three-stage product cycle framework defined by requirements in the process validation regulatory guidance documents.

Although established for the pharmaceutical industry, this seminar on Applied Statistics for FDA Process Validation also provides a useful framework for other related industries.

In this important learning on Applied Statistics for FDA Process Validation; Dr. Burdick will cover the following areas:

o  Apply statistics to set specifications and validate measurement systems (assays)

o  Develop appropriate sample plans based on confidence and power

o  Implement suitable statistical methods into a process validation program for each of the three stages

o  Stage 1, Process Design: utilize risk management tools to identify and prioritize potential critical process parameters; and define critical process parameters and operating spaces for the commercial manufacturing process using design of experiments (DOE)

o  Stage 2, Process Qualification: assess scale effects while incorporating large (pilot and/or commercial) scale data; develop process performance qualification (PPQ) acceptance criteria by characterizing intra and inter-batch variability using process design data and batch homogeneity studies; and develop an appropriate sampling plan for PPQ

o  Stage 3, Continued Process Verification: develop a control plan as part of a risk management strategy; collect and analyze product and process data; and ensure your process is in (statistical) control and capable.

Statistics for Medical Professionals

Medical statistics, also called biostatistics, is an important area for medical professionals. Statistics and the medical professionals may not seem very easily associable with each other at first glance, but a deeper look suggests the connection between statistics and the medical profession.

Statistics is a set of data and tables. These figures are meant to offer understanding and perspectives on a number of issues. When it comes to the medical profession; statistics for medical professionals becomes very important to those in the field of public health. Every time a government or an international agency of a world body such as the UN undertakes a program on public health; statistics are of immense importance for medical professionals.

Many uses of statistics for medical professionalsStatistics for medical professionals is useful in helping them analyze public health issues. Detailed figures of the incidence of malaria for instance, are a very useful piece of statistics for medical professionals. This kind of statistics helps them determine the causes of the disease and helps them decide on the plan of action.

Statistics for medical professionals is also useful at the local level. A medical professional working in a town or village could benefit immensely when she has statistics meant for medical professionals. It helps the professional understand what local causes are giving rise to health issues. Statistics for medical professionals thus helps them tackle issues at the local as well as the global levels

A specialized fieldIn developed countries, statistics for medical professionals has become a full-fledged profession. It is finessed at graduate and postgraduate programs at which they study the essentials of statistics for medical professionals. They then carry out programs that are suited for their profession.

Statistics for medical professionals is used in a wide variety of disciplines. Usually, courses on statistics for medical professionals cover the following areas:

  • Data Analysis of statistics for medical professionals
  • Dealing with Missing Data
  • Higher Issues in Trials
  • Linear Regression and Correlation
  • Logistic Regression
  • Correlated Data analysis
  • Continuous Data comparison between groups
  • Survival Data analysis
  • Risk, Rates and Odds of statistics for medical professionals
  • Randomized Trials
  • Observational Studies of statistics for medical professionals
  • Categorical Data comparison between groups
  • Calculations of Sample Size
  • Testing of Estimation and Hypothesis

More information go through this link: https://www.globalcompliancepanel.com/seminar?Linkedin_SEO

GlobalCompliancePanel announces Seasonal offers for Professionals with Flat 50% OFF on all Seminars

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Do celebrations need a cause and a reason? Yes, and GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, is having a solid cause and reason for doing so. It is celebrating the many years of its relationship with its customers spread all over the world by offering its trainings at a massive 50% discount!

Yes, that is right. GlobalCompliancePanel’s seminars will be available for a huge 50% discount till April 30. Regulatory professionals who want to augment their knowledge of regulatory compliance can now do so by paying just half the price of these trainings from GlobalCompliancePanel. All that is needed to do walk away with a rare offer such as this is to visit https://www.globalcompliancepanel.com/seminar?wordpress_SEO and use MGCP50 Promo Code.

This offer is valid till April 30, 2017. Regulatory professionals who want to take any of GlobalCompliancePanel’s trainings can book their trainings for an area of their interest by this date. From April 1 onwards, this offer will cease, meaning that the original price will apply from then.

So, why is GlobalCompliancePanel offering this discount? It is for a simple, but profound reason: It wants to thank its huge customer base for the support they have been extending to this company over the many years for which it has been in business. During the course of the 10 years for which GlobalCompliancePanel has been in business, it has trained thousands of regulatory compliance professionals from around the world.

These professionals, belonging to such varied geographies as the US and Japan and India and Canada, have been able to meet their regulatory compliance challenges on account of these trainings. These trainings are relevant, focused and valuable, and are from some of the best known regulatory compliance Experts found anywhere on this planet.

It is these trainings that have been hoping these professionals in the regulatory compliance arena gain more insights into regulations from the FDA, the EMA and other such bodies around the world. These trainings have been consistently helping them to meet these challenges, as they give them a better and sharper understanding of the implementing these requirements.

These regulatory requirements can pose hurdles to the most experienced and brightest of regulatory compliance professionals in the medical devices, pharmaceutical, life sciences and food and biologicals areas, but not to those who undertake professional trainings from GlobalCompliancePanel. GlobalCompliancePanel’s panel of experts is here to help them overcome these challenges and hurdles.

This trend has been being witnessed from the time GlobalCompliancePanel entered the line of professional trainings. Any wonder then, that no fewer than 50,000 professionals have benefited from these trainings? What could be a better way of thanking such a huge base of customers than with this offer? GlobalCompliancePanel believes that a celebration should also be useful, and this is that this offer is!

Hurry up and enroll today. Happy learning!

 

 

Statistics for the Non-Statistician: Is it necessary?

Statistics for the non-statistician: Isn’t this some kind of a contradiction in terms? Why does a non-statistician need to rake his head over statistics? Is statistics a life skill or a lifesaving one? If it is not, why is statistics for the non-statistician necessary? At first glance, statistics for the non-statistician may appear unnecessary and redundant, but a slightly deeper look will make one understand that statistics for the non-statistician is indeed important, and has uses that help to make important contributions to the organization in which they work.

For understanding processes

Statistics for the non-statistician is important because we need statistics in the course of our professions while taking important decisions in business. For those working in the corporate world, statistics for the non-statistician becomes an important tool and skill with which a deeper understanding can be made of the statistical tools and techniques that employees routinely use in an organization. Using these tools, the professional has a greater understanding of the important parameters and pointers of the business and how to bring about improvements in the quality of a firm’s process and product.

Why statistics is important for the non-statistician can also be understood from the fact that when statistics is not properly analyzed, i.e., when statistical analysis is not performed insightfully as a result of a lack of full understanding of the statistical principles and processes by the employees; the organization faces a number of problems. These range from the possibility of facing the risk of producing a poor quality product. Such a product severely retards its ability to deliver a high quality product, as a result of which there is a heavy negative impact on the organization’s bottom line, as well as a blow to its reputation.

Get to understand the importance of statistics for the non-statistician

The importance of statistics for the non-statistician can also be understood from the fact that its knowledge helps regulatory professionals meet regulatory compliance requirements without hassles. To get a clear understanding of the ways in which statistics for the non-statistician helps organizations overcome many challenges, a seminar is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance.

At this seminar on statistics for the non-statistician, Steven Walfish, the founder and President of Statistical Outsourcing Services, who brings nearly 20 years of industrial experience providing statistical solutions to complex business problems, will be the Director. To enroll for this seminar, please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900742SEMINAR?linkedin_SEO. The “Statistics for the Non-Statistician” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

It is all about practice

Practice is at the root of understanding statistics for the non-statistician. Constant practice is the mantra for employees to attain proficiency in statistics. They need a little bit of initiative, familiarity and some real-world example data sets. Employees who need training on statistics for the non-statistician need an understanding of the most common statistical tools and terms.

They need to understand

a.      how to use statistics to properly trend data

b.     support the annual product review

c.      justify process changes

d.     set product specifications.

The aspects of statistics that employees need to be familiar with

Employees who want to learn how statistics works for the non-statistician need to be able to make use of statistical software packages and understand the role of software in statistical analysis and statistical process control. They also need to have the skills necessary to design a statistically sound sampling plan that helps them comply with FDA APR requirements.

The result of this kind of familiarization is that organizations can perform their core functions and still be in alignment with statistical processes that are necessary for staying ahead of the competition. This is what statistics for the non-statistician entails.

The course on statistics for the non-statistician is immensely useful to professionals and supervisors in medical devices, diagnostics, pharmaceuticals and the biologics fields.