The use of Applied Statistics for FDA Process Validation

Why you Should be Worried about HIPAAThe use of Applied Statistics for FDA Process Validation is considered a matter of very high importance in the pharmaceutical industry. The FDA’s guidance for the industry, which it called “Process Validation: General Principles and Practices”, was set up in 2011. This guideline sets the framework for Process Validation in the pharmaceutical industry. The FDA prescribes a three-stage process that any organization in the pharmaceutical industry has to set up:

  1. Process Design
  2. Process Qualification
  • Continued Process Verification.

The Process Design stage, which is called Stage 1, is when the organization defines the commercial manufacturing process. The knowledge that the organization has gained through development and scale-up activities serves as the basis for the development of this definition.

The Process Qualification, or Stage 2, involves evaluating the process design for the purpose of determining if the process defined in Stage I has the capability for reproducible commercial manufacturing.

The next stage of the FDA process validation stage is to determine if the Process Design stage and the Process Qualification stage give the ongoing assurance that the process remains in a state of control during routine production. This is what Stage 3, the Continued Process Verification, does.

Thorough understanding of how to implement Applied Statistics for FDA Process Validation

GMPs for Combination Products and 505(b)(2) Products

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

Please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901132SEMINAR?wordpress-SEO to register for this meaningful and highly valuable seminar on applied statistics for 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 methodical approach to implementing statistical methodologies

Top 20 Costly Mistakes

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

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

The two fundamental requirements for Process Validation, namely the application of statistics for setting specifications and assessing measurement systems (assays), will be taken up next.

The next aspect of applied statistics Dr. Burdick will move on to is how to apply statistics through the three stages of process validation as defined by requirements in the process validation regulatory guidance documents.

Since 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.

The aim of this learning on Applied Statistics for FDA Process Validation is to 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.

Complete learning on Applied Statistics for FDA Process Validation

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Over the two days of this seminar, the participants will learn how to:

  • Apply statistics for setting specifications
  • Assess measurement systems (assays)
  • Use Design of Experiments (DOE)
  • Develop a control plan as part of a risk management strategy, and
  • 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 aimed at the pharmaceutical industry, this seminar on Applied Statistics for FDA Process Validation provides a useful framework for other related industries, as well.

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

  • Apply statistics to set specifications and validate measurement systems (assays)
  • Develop appropriate sample plans based on confidence and power
  • Implement suitable statistical methods into a process validation program for each of the three stages
  • 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)
  • 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
  • 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.

keep enhancing FDA Process Validation

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”

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

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

Applied Statistics for product and process evaluation in design and manufacturing

Evaluating product and processes is an imperative for almost all design and/or manufacturing companies. These are the reasons for which this evaluation needs to be made:

  • Managing risks
  • Validation of processes
  • Establishing product/process specifications to QC to such specifications
  • Monitoring compliance to such specifications

risk

Lack of proper and thorough grasp of and correct implementation of statistical methods leads a company to having to face significant increases in its complaint rates, scrap rates, and time-to-market. As a result, such companies churn out poor quality in their products, leading to lowered customer satisfaction levels, severely impacting their bottom line.

A learning session to help understand statistical methods

In order to help professionals in process and manufacturing meet challenges associated with statistical methods with greater confidence, GlobalCompliancePanel, a highly reputable provider of professional trainings for the regulatory compliance areas, is organizing a highly educative two-day seminar on the topic, “Applied Statistics, with Emphasis on Verification, Validation, and Risk Management, in R&D, Manufacturing, and QA/QC”.

regulatory-compliance

John N. Zorich, Statistical Consultant & Trainer, Ohlone College & SV Polytechnic, will be the Director at this seminar, which has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

To enroll for this seminar, participants can log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900537SEMINAR.

Hands on approach to statistical methods toolbox

The aim of this seminar is to offer a hands-on approach by which the participants could comprehend the ways to interpret and use a standard tool-box of statistical methods that consist of confidence intervals, t-tests, Normal K-tables, Normality tests, confidence/reliability calculations, AQL sampling plans, measurement equipment analysis, and Statistical Process Control.

The Director will equip the seminar delegates with clarity on how to accurately employ and administer statistical methods, which can be used as a launchpad for introducing new products.

medical-device

This two-day session will help participants understand the proper way of avoiding issues relating to these aspects of statistical methods. John will explain how to apply statistics to manage risk in R&D, QA/QC, and Manufacturing by giving real life examples derived mainly from the medical device design/manufacturing industry.

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John will cover the following areas at this seminar:

  • 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).

Applied Statistics for product and process evaluation in design and manufacturing

Evaluating product and processes is an imperative for almost all design and/or manufacturing companies. These are the reasons for which this evaluation needs to be made:

  • Managing risks
  • Validation of processes
  • Establishing product/process specifications to QC to such specifications
  • Monitoring compliance to such specifications

Lack of proper and thorough grasp of and correct implementation of statistical methods leads a company to having to face significant increases in its complaint rates, scrap rates, and time-to-market. As a result, such companies churn out poor quality in their products, leading to lowered customer satisfaction levels, severely impacting their bottom line.

appliedstats

A learning session to help understand statistical methods

In order to help professionals in process and manufacturing meet challenges associated with statistical methods with greater confidence, GlobalCompliancePanel, a highly reputable provider of professional trainings for the regulatory compliance areas, is organizing a highly educative two-day seminar on the topic, “Applied Statistics, with Emphasis on Verification, Validation, and Risk Management, in R&D, Manufacturing, and QA/QC”.

John N. Zorich, Statistical Consultant & Trainer, Ohlone College & SV Polytechnic, will be the Director at this seminar, which has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

To enroll for this seminar, participants can log on to

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900535SEMINAR?applied-statistics-QA-QC-Seattle-Washington.

Hands on approach to statistical methods toolbox

The aim of this seminar is to offer a hands-on approach by which the participants could comprehend the ways to interpret and use a standard tool-box of statistical methods that consist of confidence intervals, t-tests, Normal K-tables, Normality tests, confidence/reliability calculations, AQL sampling plans, measurement equipment analysis, and Statistical Process Control.

The Director will equip the seminar delegates with clarity on how to accurately employ and administer statistical methods, which can be used as a launchpad for introducing new products.

This two-day session will help participants understand the proper way of avoiding issues relating to these aspects of statistical methods. John will explain how to apply statistics to manage risk in R&D, QA/QC, and Manufacturing by giving real life examples derived mainly from the medical device design/manufacturing industry.