Become Better With Biostatistics for the Non-Statistician In 10 Minutes

It is aimed at professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting.

That statistics can be a vital decision-making tool for clinical research is well-established. It is helpful for the clinician in situations where a p-value can help determine the next steps in the development of a drug or procedure. It is thus vital for decision makers to comprehend the theory and application of statistics.

We have many statistical software applications that help in arriving at crucial decisions. However, almost all these software applications were developed for statisticians. These software applications could confound the non-statisticians. Their confusion could start with something as basic as even knowing which key to press.

In this scenario, learning how to use biostatistics and derive its benefits is important. A marathon, six-hour webinar being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, on October 25, will explain biostatistics for the non-statistician.

biostatistics

Elaine Eisenbeisz, a private practice statistician and owner of Omega Statistics, a statistical consulting firm based in Southern California, will be the expert at this webinar. Please visit https://www.globalcompliancepanel.com/virtual-seminar/6-hour-virtual-seminar-on-biostatistics-for-the-non-statistician-10307LIVE to register for this webinar.

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This webinar, designed for non-statisticians, provides a non-mathematical introduction to biostatistics. Elaine will arm the participants with all the information and skills necessary for understanding statistical concepts and findings as they apply to clinical research, and to confidently convey this knowledge to people with whom they work.

This webinar will emphasize statistical concepts, application, and interpretation, and not on mathematical formulas or actual data analysis. Participants are expected to have an elementary understanding of statistics, but this is not mandatory.

It is aimed at professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting.

This will be the agenda that will be covered at this webinar:

Why Statistics?

  • Do we really need statistical tests?
  • Sample vs. Population
  • I’m a statistician not a magician! What statistics can and can’t do
  • Descriptive statistics and measures of variability

The many ways of interpretation

  • Confidence intervals
  • p-values
  • effect sizes
  • Clinical vs. meaningful significance

Common Statistical Tests

  • Comparative tests
  • Regression analysis
  • Non-parametric techniques

Bayesian Logic

  • A different way of thinking
  • Bayesian methods and statistical significance
  • Bayesian applications to diagnostics testing
  • Bayesian applications to genetics

Interpreting Statistics – Team Exercise

  • Team Exercise: Review a scientific paper and learn how to
    • Interpret statistical jargon
    • Look for reproducibility, transparency, bias, and limitations
    • Convey information coherently to non-statisticians

Study power and sample size

  • Review of p-value, significance level, effect size
  • Formulas, software, and other resources for computing a sample size

Developing a Statistical Analysis Plan

  • Using FDA guidance as a foundation, learn the steps and criteria needed to develop a statistical analysis plan (SAP).
  • An SAP template will be given to all attendees.

Specialized topics/Closing Comments/Q&A

  • Comparing Survival Curves
  • Pharmacokinetics/Pharmacodynamics (PK/PD)
  • Taking a holistic view to study design and interpretation
  • Question and Answer session.

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About the Director:

Elaine brings over 30 years of experience in creating data and information solutions for industries ranging from governmental agencies and corporations to start-up companies and individual researchers. She has designed the methodology for numerous studies in the clinical, biotech, and health care fields.

She currently is an investigator on approximately 10 proton therapy clinical trials for Proton Collaborative Group, based in Illinois. She also designs and analyzes studies as a contract statistician for nutraceutical and fitness studies with QPS, a CRO based in Delaware.

GlobalCompliancePanel to organize two-day seminar on “FDA and U.S. Customs Import Rules and Export Traps in 2020”

This plan seeks to reward importers who demonstrate a level of confidence about the quality of food they import by establishing an FDA-supervised, fee-based program.

GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, is organizing a two-day, in person, live seminar on the topic, “FDA and U.S. Customs Import Rules and Export Traps in 2020”, on December 4 and 5.

Casper Uldriks, an ex-FDA Expert and former Associate Center Director of CDRH, will be the Director of this seminar. Please enroll for this session by visiting https://www.globalcompliancepanel.com/seminar/tougher-import-rules-for-FDA-901966SEMINAR

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Smarter, more sophisticated, more agile and more demanding. These are what the FDA and the Customs and Border Patrol Service (CBP) have become of late when it comes to their expectations and requirements from importing firms of the submission of information and adherence to government procedures. Firms that fail to properly execute an import and export program can expect the FDA and the CBP to delay, detain or refuse their shipments.

The new Automated Commercial Environment (ACE) computer program from the CBP has brought in many changes to the process of import logistics and information reporting for FDA regulated products. As a result, companies that do not comply with the requirements set out in the ACE program can experience one of the worst nightmares they can think of: having their shipment stopped before it is even loaded at the foreign port! And then, if they refuse to or fail to use the ACE program, such ships also carry a fine of up to $10,000 for every offense.

Embedded-Software-Development

There is more: such companies whose products the FDA detains face a cumbersome, long winding and expensive legal process. The FDA expects companies to have the import coding information accurate and up-to-date. Any company that lacks a thorough and clear understanding of the automated and human review process are almost certain to have their shipments detained.

And then, what happens in a scenario in which the FDA decides that importers should bring the products back to the port of entry after they received a release but cannot locate the product that has been sold? Well, in such instances, such companies are slapped a fine that is three times the value of the shipment, not to speak of the additional adverse legal concerns and strategies that come along.

What do all these mean? Simple: if you are an importer, you are doomed if you fail to comply with the FDA’s guidelines on imports.

Yet, there is a way out of this quagmire, in the form of the Voluntary Qualification Importer Program, which the FDA is implementing under the FDA Food Safety and Modernization Act. This plan seeks to reward importers who demonstrate a level of confidence about the quality of food they import by establishing an FDA-supervised, fee-based program. What this program does is that it facilitates the review and importation of foods from importers who establish a higher level of control over the safety and supply chain aspects of the imported food items.

And then, there is also the extra perk that the FDA offers: its export certificates. Offered at a reasonable fee; these certificates can go a long way in giving an importer a competitive advantage in foreign markets. In fact, a few foreign governments make an FDA export certificate a requirement.

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The aim of this seminar is to offer learning on all these core areas of the FDA and US Customs Import Rules in 2020. The Director will explain how to deal with common problems, such as returns for repair, importing QC samples, and investigational products. The learning will be taught over the following agenda:

Day 1 Schedule

Lecture 1:

FDA Legal Authority Customs and Border Control (CBP) Import Process FDA Import Process Registration and documentation

Lecture 2:

FDA Import Process (continued)

  • Import Brokers
  • Prior Notice Information
  • CBP and FDA computer programs
  • Import Codes
  • Bonds and Bonded Warehouses
  • FDA “Notice of Action”

Lecture 3:

Import Delays Import Alerts Detention Refusals

Day 2 Schedule

Lecture 1:

Foreign Inspections FDA 483 – Inspectional Observations

Lecture 2:

FDA Warning Letters and Automatic detention

Lecture 3:

Import Hypothetical FDA Import for Export Program FDA Export Program Export Hypothetical

Lecture 4:

FDA Export Program Special Import Issues

  • Trade Shows
  • Personal Use
  • Compassionate Use

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https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm448728.htm

Best Biostatistics Tips You Will Read This Year

How do you know if you are pressing the right key, let alone performing the best test?

Statistics is a useful decision making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand the theory and application of statistics.

Many statistical softwares are now available to professionals. However, these softwares were developed for statisticians and can often be daunting to non-statisticians. How do you know if you are pressing the right key, let alone performing the best test?

biostatistics

This seminar provides a non-mathematical introduction to biostatistics and is designed for non-statisticians. And it will benefit professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting.

The focus of the seminar is to give you the information and skills necessary to understand statistical concepts and findings as applies to clinical research, and to confidently convey the information to others.

Emphasis will be placed on the actual statistical (a) concepts, (b) application, and (c) interpretation, and not on mathematical formulas or actual data analysis. A basic understanding of statistics is desired, but not necessary.

  • Physicians
  • Clinical Research Associates
  • Clinical Project Managers/Leaders
  • Sponsors
  • Regulatory Professionals who use statistical concepts/terminology in reporting
  • Medical Writers who need to interpret statistical reports

How to interpret and use more than just a standard tool-box

Metrology: QC Sampling Plans the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications.

How to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows:

  • ISO standards and FDA/MDD regulations regarding the use of statistics.
  • Basic vocabulary and concepts, including distributions such as binomial, hypergeometric, and Normal, and transformations into Normality.
  • Statistical Process Control
  • Statistical methods for Design Verification
  • Statistical methods for Product/Process Qualification
  • Metrology: QC Sampling Plans the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications
  • How to craft “statistically valid conclusion statements” (e.g., for reports)
  • Summary recommendations

The various statistical methods used to support such activities can be intimidating. If used incorrectly or inappropriately, statistical methods can result in new products being launched that should have been kept in R&D; or, conversely, new products not being launched that, if analyzed correctly, would have met all requirements. In QC, mistakenly chosen sample sizes and inappropriate statistical methods may result in purchased product being rejected that should have passed, and vice-versa.

This provides a practical approach to understanding how to interpret and use more than just a standard tool-box of statistical methods; topics include: Confidence intervals, t-tests, Normal K-tables, Normality tests, Confidence/reliability calculations, Reliability plotting (for extremely non-normal data), AQL sampling plans, Metrology (i.e., statistical analysis of measurement uncertainty ), and Statistical Process Control. Without a clear understanding and correct implementation of such methods, a company risks not only significantly increasing its complaint rates, scrap rates, and time-to-market, but also risks significantly reducing its product and service quality, its customer satisfaction levels, and its profit margins.

  • FDA, ISO 9001/13485, and MDD requirements related to statistical methods
  • How to apply statistical methods to manage product-related risks to patient, doctor, and the designing/manufacturing company
  • Design Control processes (verification, validation, risk management, design input)
  • QA/QC processes (sampling plans, monitoring of validated processes, setting of QC specifications, evaluation of measurement equipment)
  • Manufacturing processes (process validation, equipment qualification)

product-development-process-e1395175968927

  • QA/QC Supervisor
  • Process Engineer
  • Manufacturing Engineer
  • QC/QC Technician
  • Manufacturing Technician
  • R&D Engineer

Dont skip this with out reading fully

Auditing Analytical Laboratories for FDA Compliance

The social interactions that must be expected, the nature of the regulatory requirements and the nature of work that the laboratory performs will be discussed.

There are two phases to this topic. The first is auditing itself. Good audits are well structured. They must consider the reasons for the audit, the regulatory requirements, as well as the nature of the laboratory being audited. We will discuss the considerations that must be made when auditing a laboratory. The social interactions that must be expected, the nature of the regulatory requirements and the nature of work that the laboratory performs will be discussed.

what-to-expect-from-an-energy-audit

The second phase considers what must be considered during the audit itself. Audits conducted by inexperienced or ignorant auditors are often worthless, wasting the time and money of both the auditors and the laboratory being audited. Auditors who are familiar with laboratory operations are needed as it is easy to be fooled into thinking that a non-compliant laboratory is operating normally. Different types of laboratories will require different auditor/specialists. We will discuss the pitfalls that auditors can fall into, and what questions laboratories may expect to encounter.

It is necessary for a company to know if an analytical laboratory is capable of operating in compliance with GMP or other regulations. This is especially critical if the laboratory is a quality control laboratory whose test results will be used to support the release of a product to the public or to support and application for permission to market a product.  The failure of a quality control laboratory to comply with regulations can result in the failure of a request for permission to market a product or a forced recall of a marketed product.

In extreme cases a revocation of the permission to market a product may be the result. In any case the inability to conform to regulations will result in a loss of confidence in the ability of the manufacturer to produce a product that meets quality and regulatory requirements, and, in turn, lead to a refusal to purchase a product.

It is critical that the audit of the laboratory be conducted in a professional manner, as a poor audit will waste money and lead to a false confidence in the abilities of the audited laboratory whether it is internal or external to the company.

  • Potential Auditors
  • Supervisors who must initiate Audits
  • Laboratory Supervisors and Workers
  • Quality Assurance and Control Supervisors and Lead Workers
  • Supervisory Management who must select Contractors
  • Managers
  • Directors
  • Vice Presidents who Supervise Quality Assurance
  • Quality Control
  • Regulatory Affairs Groups

Top benefits from this

200+ followers. WOWWWWWW…

followed- 200

Hello Everyone,

Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone.  we never expected to actually to connect with other people in the blogging community.

we are so incredibly thankful for each and every one of you who follows and comments on my blog posts. Please know that!

we would continue our blogging in these areas FDA Regulation, Medical Devices, Drugs and Biologics, Healthcare Compliance, Biotechnology, Clinical Research, Laboratory Compliance, Quality Management ,HIPAA Compliance ,OSHA Compliance, Risk Management, Trade and Logistics Compliance ,Banking and Financial Services, Auditing/Accounting & Tax, Packaging and Labeling, SOX Compliance, Environmental Compliance, Microsoft Excel Spreadsheet, Geology and Mining, Human Resources Compliance, Food Safety Compliance and etc.

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It is important for non-statisticians to become familiar with biostatistics

biostatistics

Statistics is extremely useful as a decision-making tool in the clinical research arena. In areas such as working in a field where a p-value can determine the next steps on development of a drug or procedure, it is very handy, because of which it is imperative for decision makers to understand the theory and application of statistics.

Many statistical software applications have now been developed and made available to professionals. It needs to be borne in mind that these software applications were developed for statisticians, because of which its use can baffle non-statisticians. Their confusions could be as basic as pressing the right key, let alone performing the best test.

A full learning session on biostatistics for the non-statistician

biostatistics5

A seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will throw light on the importance of biostatistics for the non-statistician.

Elaine Eisenbeisz, a private practice statistician and owner of Omega Statistics, a statistical consulting firm based in Southern California, who has over 30 years of experience in creating data and information solutions for industries ranging from governmental agencies and corporations to start-up companies and individual researchers; will be the Director of this seminar.

Want to understand the importance of biostatistics for the non-statistician? Then, please enrol for this seminar by visiting It is important for non-statisticians to become familiar with biostatistics. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Statistical concepts in clinical research

biostatistics2

Designed essentially for non-statisticians; this seminar provides a non-mathematical introduction to biostatistics. It will be of high value to professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting.

Elaine will equip participants of this seminar with the information and skills necessary to understand statistical concepts and findings as they relate to clinical research. With this information, they will be able to confidently communicate with people with whom they need to.

Elaine will place emphasis on the actual statistical concepts, application, and interpretation. She will not go into the areas of mathematical formulas or actual data analysis. A basic understanding of statistics is desired from the participants, but is not necessary.

This course on biostatistics for the non-statistician will help professionals involved in this area, such as Physicians, Clinical Research Associates, and Clinical Project Managers/Leaders, Sponsors, Regulatory Professionals who use statistical concepts/terminology in reporting, and Medical Writers who need to interpret statistical reports.

Elaine’s agenda for this two-day seminar will consist of the following:

Why Statistics?

biostatistics56

  • Do we really need statistical tests?
  • Sample vs. Population
  • I’m a statistician not a magician! What statistics can and can’t do
  • Descriptive statistics and measures of variability

The many ways of interpretation

  • Confidence intervals
  • p-values
  • effect sizes
  • Clinical vs. meaningful significance

Common Statistical Tests

  • Comparative tests
  • Regression analysis
  • Non-parametric techniques

Bayesian Logic

  • A different way of thinking
  • Bayesian methods and statistical significance
  • Bayesian applications to diagnostics testing
  • Bayesian applications to genetics

Interpreting Statistics – Team Exercise

biostatistics3

  • Team Exercise: Review a scientific paper and learn how to
    • Interpret statistical jargon
    • Look for reproducibility, transparency, bias, and limitations
    • Convey information coherently to non-statisticians

Study power and sample size

  • Review of p-value, significance level, effect size
  • Formulas, software, and other resources for computing a sample size

Developing a Statistical Analysis Plan

Specialized topics/Closing Comments/Q&A

  • Comparing Survival Curves
  • Pharmacokinetics/Pharmacodynamics (PK/PD)
  • Taking a holistic view to study design and interpretation
  • Question and Answer session.

 

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