The importance of Design of Experiments (DoE)

Design of Experiments (DoE) is an important component in many industries. It is a series of tests or runs that is carried out repeatedly and consistently over a period of time, and its outputs or responses, observed. Design of Experiments is very important in industry to help arrive at an understanding of the predictability and reproducibility of an experiment.

Design of Experiments is a very important aspect of the important elements of a product, such as quality, reliability and performance. What Design of Experiments does is that it helps to examine and investigate the inputs that lead to poor quality. This insight leads the entity carrying out the Design of Experiments to use these to improve their quality standards.

 

Ruling out chance

Design of Experiments does not rely on chance or providence to bring about the quality that is required of an experiment. It arrives at the optimal set of procedures that are needed to get the required quality standards after a series of tests and experiments, so that the final result shows in the process that goes into the product.

Fundamentally, Design of Experiments helps to put in place a system of control for a product. All the ingredients that go into the inputs needed for obtaining a product of a defined standard or quality are scientific and precise. This precision and accuracy is arrived at after carrying out as many runs or series of Design of Experiments as needed to finally arrive at it.

An introduction to Design of Experiments

The ways of understanding Design of Experiments and applying their standards into production will be the topic of a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all areas of regulatory compliance. At this webinar, the speaker, William Levinson, an ASQ Fellow, Certified Quality Engineer, Quality Auditor, Quality Manager, Reliability Engineer, and Six Sigma Black Belt, who is the principal of Levinson Productivity Systems, P.C., will explain the fundamentals of Design of Experiments.

To gain a proper understanding of the principles of Design of Experiments and to get a grasp of how to implement this concept into your systems, please register for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501202?Wordpress-SEO

An understanding of the significance level in hypothesis testing

William will make participants understand how to use Design of Experiments to identify and rule out the particular item or input that affects quality. The concept of significance level in hypothesis testing, which will serve as a basis for not only DoE, but also Statistical Process Control and acceptance sampling, will be explained.

A description of the other uses of DoE, such as supporting Corrective and Preventive Action (CAPA) and in process improvement, where it helps to identify and optimize the factors influenced by Critical to Quality (CTQ) characteristic, will be part of the learning that is on offer at this webinar.

 

 

Levinson will cover the following areas at this webinar:

·        Economic benefits of DOE

·        Hypothesis testing: the foundation of DOE, SPC, and acceptance sampling

o  Null and alternate hypothesis

o  Type I or alpha risk of concluding wrongly that the experiment differs from the control (or that a process is out of control, or that an acceptable production lot should be rejected)

o  Type II or beta risk of not detecting a difference between the control and the experiment, not detecting an out of control condition, and accepting a production lot that should be rejected

·        Factors, levels, and interactions

o  Interaction = “the whole is greater or less than the sum of its parts”. One variable at a time experiments cannot detect interactions.

·        Randomization and blocking exclude extraneous variation sources from the experiment.

·        Replication means taking multiple measurements to increase the experiment’s power.

·        Interpret the experiment’s results in terms of the significance level, or quantifiable “reasonable doubt” that the experiment differs from the control.

http://support.minitab.com/en-us/minitab/17/topic-library/modeling-statistics/doe/basics/what-is-a-designed-experiment/

Making Big Data big in terms of effectiveness

Our world today is unthinkable without data. We seem to be flooded by it. Day in and day out, the world processes trillions of bytes. Big Data seems to be everywhere and has compounded our already heavy reliance on data.

But has this proliferation of data made any significant difference to our lives? Has it made our business decision-making any more effective or insightful? What has this surfeit of data meant in terms of usefulness and value? Does reliance on Big Data necessarily mean better business decisions?

Making sense of data

Translating tomes and tomes of this data into something that is useful is a big challenge in today’s world. This is a capability that needs to be translated into tangible, competitive strength, if quality and compliance have to be improved. Data Management and Quality metrics are important tools that can help in a host of important functions such as forecasting, resource allocation, risk management, decision making, and continuous improvement.

Susanne Manz, who is an accomplished leader in the medical device industry emphasizing on quality, compliance, and Six Sigma, will impart the insightfulness needed to make sense of Big Data to participants of a webinar that Compliance4All, a highly popular provider of professional trainings for all the areas of regulatory compliance, is organizing.

In order to understand what perceptiveness can be inculcated into understanding and analyzing Big Data to aid in decision-making, just log on to http://www.compliance4all.com/control/w_product/~product_id=501044 to register.

Absolutely useful aid in decision-making for management review

Management Review, among the fundamental requirements of a suitable Quality System; relies on timely, accurate and complete information to make risk-based decisions. An organization that is immersed in data that leads nowhere in helping it with the critical information to ensure product safety and effectiveness has no use from this kind of Big Data.

Organizations need to have not heaps of data, but what in it gives them the ability to measure to understand quality, compliance, and customer satisfaction. This is the test of the accuracy, completeness and timeliness of their data. The aim of this webinar is to help participants develop the data management processes that help them optimize their quality system efficiency and effectiveness.

Susanne will cover the following areas at this webinar:

o  What metrics are needed for quality and compliance success

o  Sources of data

o  Analytics capabilities

o  Descriptive and Predictive Data

o  Structure and process for managing data

o  Data Governance

o  Data Preparation

o  Using data for forecasting, continuous improvement, and management review.

Cost-effective regulatory compliance trainings get even more cost-effective!

There are offers, and then there are super offers. Finally, there are Compliance4All offers! Yes, Compliance4All has an offer that is so unique that it can be considered a step above being a super offer. What is this offer, then? Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, has just announced that it is offering a 50% off on its webinar packs. Wait. Don’t rush for your reading glasses. You’ve read it right.

capture

Yes, IT IS a 50% discount that Compliance4All is offering. And on what, did you ask? This is the deal stealer: Its bestselling courses! Read on to learn more about this great, unique opportunity to enhance your learning on the areas of regulatory compliance. With this killer deal, Compliance4All simply knocks off all the hurdles that stood between you and the accomplishment of world-class trainings on regulatory compliance: Costs, relevance to your industry, and completeness.

Cost-effective, complete and complementary

Let us admit it. Everyone knows that in today’s highly competitive and fast paced industry, regulatory compliance trainings are the must-have for all professionals. But how many can afford this on a regular basis? The trainings cost the heavens. A look at the prices of some of these courses is sure to give your jitters and raise your eyebrows.

And then, how complete are these courses? They are important and useful no doubt, but it is equally true that many courses leave you asking for more, because you would discover at the completion of the course that there are many areas that the expert left uncovered. Is this not what had prevented you from gaining the full benefit of regulatory compliance trainings?

50-off

Addressing all your issues at once

It is to address this exact pain point that Compliance4All has come up with a bumper offer. This is how the webinar packs are designed:

Packs of 18, 20, 40 and 50 webinars have been created, all of which are related to each other because of the proximity and relationship each webinar has with the others. Compliance4All got its experienced staff to hem these courses together based on a number of factors; relevance and complementarity to each other being the foremost of these.

Each of these packs has webinars that are meant to complete the learning need of the participant by appending each other. This is a very important gap that is being filled by Compliance4All, because it learned that this was the main grouse most takers of regulatory compliance usually complained about.

The details of the offer

So, this is how the offers run:

  • Pack of 18 webinars:

$1,710 (regular price $3,420)

  • Pack of 20 webinars:

$ 1,900 (regular price $3,800)

  • Pack of 40 webinars:

$ 3,800 (regular price $ 7,600)

  • Pack of 50 webinars:

$ 4,750 (regular price $ 9,500).

All this leaves something to be done: your signing up! Just visit http://www.compliance4all.com/ to complete the formalities!

Elements of a Cyber Security Incident Response Program

A Cyber Security Incident Response Program (CSIRP) or a Cyber Security Incident Response Team (CSIRT) that anticipates and neutralizes a cyber-incident is a critical need for organizations, because an Internet or network security breach results in loss of valuable data, as well as several resources and the organization’s reputation and could potentially invite lawsuits.

While putting a CSIRP in place; the management has to take into consideration the fact that Information Security, Governance & Risk, are all critical aspects of planning and execution of the Information Security Plan. It has to decide who in the organization has the key responsibility towards developing an information security governance program. It has to also review existing Information Security policies and standards to gauge their sufficiency vis-à-vis industry best practices, and update them as needed, while meeting the requirements set out by compliance regulations.

A webinar to help understand CSIRP

The effective ways of doing this will be the focus of a webinar that is being organized by Compliance4All, a highly popular provider of professional trainings for all areas of regulatory compliance. Dr. (Ms.) Michael Redmond, CEO and Lead Consultant for Redmond Worldwide, who served as an Adjunct Professor for Continuity Management at New York University and the Master’s program at John Jay College, will be the speaker at this webinar. More details of this course can be had from http://www.compliance4all.com/control/w_product/~product_id=500961LIVE/

Scope of the training session

Ms. Redmond will teach participants of this webinar the ways by which their organizations can put a CSIRP in place. She will help them establish Key Performance Indicators (KPI) to determine if their CSIRP meets business objectives and operational metrics for effecting process improvement. She will also show participating organizations the ways of tailoring and enhancing their existing CSIRP and requirements for specific audiences based on the sensitivity of the information for which they are granted based on policies.

Other important learning outcomes offered at this session include how to strengthen IT Risk Management, which involves integrating information security risk management with Enterprise Risk Management and requires using common business terminology, congruent methods, and common or linked risk register, and establishing mechanisms for risk acceptance. Ms. Redmond will also explain to participants how they can build an IS regulation review process, schedule regulation requirements and put in place a set of procedures that help to deal with a breach, malware and related issues.

Good documentation lies at the heart of GxP environments

Good Documentation Practice (GDP) constitutes the backbone of any GxP environment. Not only is GDP a sound business practice; it is also an FDA requirement. This being the case, it is absolutely essential for FDA-regulated organizations to get their GDP right. An organization that does not get its GDP right risks facing a number of consequences.

Today’s regulatory requirements are stricter than ever before. In this environment of very rigid regulatory environment; individuals and companies have to comprehend and adhere to good documentation that meets FDA regulatory requirements.

A learning session to help get an idea of GDP:

In order to make those in regulatory professions understand the essence of GDP for GxP environments, Compliance4All, a highly reputable provider of professional trainings for the regulated industries, is organizing a very valuable webinar. Details of this webinar can be had from http://www.compliance4all.com/control/w_product/~product_id=500978LIVE.

The speaker at this webinar, John Godshalk, will make participants understand what needs to be documented, and the rationale for it, such as what companies need to know to comply with regulations regarding documentation, what Good Documentation Practice (GDP) is, what needs to be documented, why it is documented, and FDA expectations for documentation.

Learning to understand the FDA’s requirements for GDP:

This learning session will explain what the GxP regulations and guidances say about Good Documentation Practice and offer examples of both good and poor documentation. It will offer exercises of both good and poor practices, which will help participants to come up with GDP that meets FDA requirements.

This session will give participants an idea of GDP for GxP environments. They will be able to understand what the FDA looks for in documentation, the relevant regulations that exist for documentation, and the related guidances.

John will cover the following areas at this webinar:

  • FDA 101: Who is the FDA, regulations, guidances, documentation and me
  • Why document?
  • What needs to be documented?
  • What documentation does FDA look for during an inspection?
  • What do the GMP, GCP, and GLP regulations and guidance’s say about documentation?
  • Examples and exercises for good documentation
  • Summary/Q&A

Contact Information:

http://www.compliance4all.com/

+1-800-447-9407

Microbial monitoring becomes successful when myths about the topic are removed

Although unfortunate; it is true that those who work in water systems design them keeping obsolete concepts in mind. Why this happens is that the water systems organization is reluctant to be open-minded enough to update its water systems from time to time. The result is that the water systems get built on a shaky foundation, making them fundamentally weak.

Myths are the backbone of water systems failures

An additional problem faced by most microbial monitoring systems is the number of myths that have emerged from this field, which is mainly due to the major misunderstanding that professionals have regarding the topic of microbial monitoring.

Addressing these myths is the main purpose of a webinar that Compliance4All, a highly reputable provider of professional trainings in a number of areas including regulatory compliance, is organizing.

This webinar, for which water systems professionals in a number of positions can enroll by just logging on to http://www.compliance4all.com/control/w_product/~product_id=500969LIVE, will be from none other than the world renowned expert on pharmaceutical water systems, Teri C. Soli.

An in-depth look at the fallacies and misconceptions of water systems implementation

Dr. Soli will discuss the reasons for which such fallacies happen, but greater attention will be paid to how these systems can be corrected. He will drive home the point that if this has to happen, a few established myths have to be shattered.

This session seeks to quash popular myths surrounding water systems, the most important reason for which water systems go awry. Most of these myths relate to microbial control approaches and microbial monitoring. For microbial monitoring to be effective, myths resulting out of misconceptions need to be removed from many areas.

Putting the myths and facts in perspective

During this webinar, Dr. Soli will take up and demolish each myth surrounding water systems and will explain the scientific, not the “rule of thumb” approach, to each of these.

He will take up the following areas for discussion and set many misconceptions surrounding them right:

o   Why water myths develop:

·        Impact of c-GMPs

·        Well-meaning but misguided precedents

·        Scientifically unchallenged traditions and benchmarking

·        Rule-hungry culture

o   Water System Microbial Control Myths:

·        WFI from RO

·        Turbulent Flow and Flow Rate

·        Dead Leg Rules

·        Smooth Surfaces

·        In-Line Sterilizing Filters

·        Ozone

o   Microbial Enumeration Myths:

·        Referee Methods

·        Thermophiles in Hot Systems

·        R2A, 35°C, 5 days

·        Test Filter Membrane Rating

·        Compendial Action Levels

·        TOC and Endotoxin as Microbial Count Correlates

Contact Information:

http://www.compliance4all.com/

+1-800-447-9407