Seminar Calendar of Upcoming Courses – June to July – 2017

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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

Understanding the practical application of statistics?

The application of statistical methods is specified all through 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries for these activities:

o  Setting validation criteria and specifications

o  Performing Measurement Systems Analysis (MSA)

o  Conducting stability analysis

o  Using Design of Experiment (DOE) for process development and validation

o  Developing process control charts

o  Determining process capability indices.

The Quality System Regulation (QSR) for medical devices states that manufacturers should take steps, where appropriate, for establishing and maintaining procedures with which to identify valid statistical techniques needed to establish, control, and verify that the process capability and product characteristics are acceptable.

Methods are specified in 21 CFR and guidance documents

Both 21 CFR and guidance documents emphasize the need for statistical methods from discovery through product discontinuation. While 21 CFR specifies the suitable statistical procedures needed to establish both in-process and final specifications; the guidance documents require applying statistical methods for development and validation of measurement systems, process understanding using Quality by Design (QbD) principles, process validation, as well as ensuring that the manufacturing process is in a state of control and is capable.

Even though many statistical methods may be applied to fulfil this part of the QSR; there exist a few commonly accepted methods that all companies can and preferably should use for:

o  Developing acceptance criteria

o  Ensuring accurate and precise measurement systems

o  Fully characterizing manufacturing processes

o  Monitoring and controlling process results, and

o  Selecting an appropriate number of samples.

Learn the dynamics of statistical methods

The nitty gritty of application of statistical methods will be the teaching a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will be offering. At this seminar, Heath Rushing, who is the cofounder of Adsurgo and author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP; will be the Director.

This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion. To understand the areas of implementation of statistical methods that comply with the requirements set out in CFR 21 and guidance documents, please enroll for this session by visiting “Understanding the practical application of statistics”

A full description of statistical processes

This course provides instruction on the statistical methods for data analysis of applications related to the pharmaceutical, biopharmaceutical, and medical device industries. The Director will explain the appropriate statistical approaches: descriptive statistics, data intervals, hypothesis testing, ANOVA, regression, ANCOVA, and model building need to be applied. Upon establishment of competence in each of these areas; he will present the way these need to be applied in an industry-specific manner.

During the course of these two days, Heath will cover the following areas:

·        Describe and analyze the distribution of data

·        Develop summary statistics

·        Generate and analyze statistical intervals and hypothesis tests to make data-driven decisions

·        Describe the relationship between and among two or more factors or responses

·        Understand issues related to sampling and calculate appropriate sample sizes

·        Use statistical intervals to setting specifications/develop acceptance criteria

·        Use Measurement Systems Analysis (MSA) to estimate variance associated with: repeatability, intermediate precision, and reproducibility

·        Ensure your process is in (statistical) control and capable.

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!

 

 

Applied statistics for scientists and engineers

Applied statistics for scientists and engineers is necessary for a number of reasons. 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries specify the application of statistical methods for these functions:

o  Setting validation criteria and specifications

o  Performing Measurement Systems Analysis (MSA)

o  Conducting stability analysis

o  Using Design of Experiment (DOE) for process development and validation

o  Developing process control charts, and

o  Determining process capability indices.

Since scientists and engineers are at the heart of these functions, they need to have a thorough knowledge of how to use applied statistics. Each of these particular applications requires different and specified statistical methods. The common tools used for setting acceptance criteria and specifications are data and tolerance intervals, while for setting expiries and conducting stability analysis studies; simple linear regression and analysis-of-covariance (ANCOVA) are used.

For analyzing designed experiment for process development and validation studies, two-sample hypothesis tests, analysis-of-variance (ANOVA), regression, and ANCOVA are methods used, while for developing process control charts and developing process capability indices; descriptive statistics (distribution, summary statistics), run charts, and probability (distributions) are used.

Explaining the importance of applied statistics for scientists and engineers

A seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will explain the importance of applied statistics for scientists and engineers.

In the course of making the importance of applied statistics for scientists and engineers known; the Director at this seminar, Heath Rushing, who is the cofounder of Adsurgo and author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP, and has been an invited speaker on applicability of statistics for national and international conferences, will provide instruction on applied statistics for scientists and engineers and statistical methods for data analysis of applications related to the pharmaceutical, biopharmaceutical, and medical device industries.

To enroll for this highly valuable and practical course on applied statistics for scientists and engineers, just register by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900790?wordpress_SEO .

The course “Applied Statistics for Scientists and Engineers” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

The tools that help an understanding of applied statistics for scientists and engineers

This course on applied statistics for scientists and engineers will offer thorough instruction on how scientists and engineers need to apply the appropriate statistical approaches: descriptive statistics, data intervals, hypothesis testing, ANOVA, regression, ANCOVA, and model building. The Director will present the ways of establishing competence in each of these areas and industry-specific applications.

The application of statistical methods across the product quality lifecycle is specified in the 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries. There are many statistical methods that may be applied to satisfy this portion of the QSR. Yet, some commonly accepted methods can and should be used by all companies to:

o  Develop acceptance criteria

o  Ensure accurate and precise measurement systems

o  Fully characterize manufacturing processes

o  Monitor and control process results and

o  To select an appropriate number of samples.

At this seminar on applied statistics for scientists and engineers, Rushing will provide instruction on all these. He will cover the following areas over the two days of this seminar:

o  Describe and analyze the distribution of data

o  Develop summary statistics

o  Generate and analyze statistical intervals and hypothesis tests to make data-driven decisions

o  Describe the relationship between and among two or more factors or responses

o  Understand issues related to sampling and calculate appropriate sample sizes

o  Use statistical intervals to setting specifications/develop acceptance criteria

o  Use Measurement Systems Analysis (MSA) to estimate variance associated with: repeatability, intermediate precision, and reproducibility

o  Ensure your process is in (statistical) control and capable

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.