Tools and Methodologies to Predict and Improve Product Reliability

Improving product reliability may be the primary objective of reliability analysis; yet, there are many possible reasons for collecting and analyzing reliability data. There are many examples of collecting and analyzing reliability data. This could be done to assess product reliability in the field. It could be to predict product warranty costs. It could be for estimating replacement part/spares requirements.

Other examples of collecting and analyzing reliability data include:

  • To assess the effect of a proposed design change
  • To demonstrate product reliability to customers or government agencies
  • To compare components from multiple suppliers
  • To compare components from different production periods, operating environments, or materials
  • For improving reliability through the use of laboratory experiments.

Methodologies for doing these

There is a certain overall methodology for setting reliability targets, estimating product reliability from test data and/or field data, and determining whether or not reliability targets are achieved. The intricacies of this methodology will be the content of a two-day, in person live seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas.

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Steve Wachs, who is currently a Principal Statistician at Integral Concepts, Inc., brings over 25 years of wide-ranging industry experience in both technical and management positions. To derive the benefit of hearing this experienced professional, just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900409SEMINAR to register. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Calculating sample sizes

Steve will discuss the methods for estimating the reliability of subsystems and systems. He will also show how to calculate sample sizes for reliability testing and utilize reliability models to develop forecasts of future failures (e.g. warranty forecasts).

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This course will immensely benefit anyone with an interest in product quality and reliability, such as Product Engineers, Reliability Engineers, Design Engineers, Quality Engineers, Quality Assurance Managers, Project/Program Managers, or Manufacturing Personnel.

Steve will help participants with the following:

  • Understand reliability concepts and unique aspects of reliability data
  • Understand underlying probability and statistical concepts for reliability analysis
  • Develop competency in the modeling and analysis of time-to-failure data
  • Understand reliability metrics and how to estimate and report them
  • Estimate reliability of subsystems and systems
  • Determine if reliability specifications are met (at specified confidence level) or whether design improvements are required
  • Develop competency in the planning of reliability tests (excluding ALT)
  • Analyze existing warranty data to predict future returns
  • Develop awareness of more advanced topics in Reliability

New Way of Exploring Economic Environment

Lineament analysis in geological exploration

The existence of efficient and cost-effective methods that help to identify prospective targets that are related to or are influenced by tectonic structures is not common knowledge among professionals in the field of geological exploration.

The right sampling and Quality Assurance/Quality Control (QA/QC) procedures are essential in all aspects of the mineral deposit evaluation process to achieve the best possible confidence in resultant mineral resource and reserve estimates.

Getting Quality Assurance and Quality Control procedures and protocols right is crucial

Accurate and proper QA and QC procedures and protocols are essential to ensure that data collected and created by the mining organization is of a high level of quality and is in compliance with CIM Standards and Guidelines. Geological quality control procedures are meant to monitor precision and accuracy of the assay data, as well as possible sample contamination during sample preparation and assaying. The quality of the data used determines the quality of an estimate.

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To offer a complete understanding of this concept, GlobalCompliancePanel, a reputable provider of professional trainings for all areas of regulatory compliance, will be organizing a two-day, live seminar. Please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900719SEMINAR?new-economic-environment-Boston-MA.

The Director of this seminar, Ricardo Valls, will introduce to the participants a methodology that will help them to concentrate their exploration efforts even over new areas with limited or nonexistent geological information, while keeping their budget in check.

The centrality of QA&QC procedures

Ricardo will explain how lineament and satellite interpretation are a way to define where to concentrate exploration efforts, as well as how to implement QA&QC procedures to guarantee the quality of the collected data. This is necessary, considering that compliance with the industry-established QA/QC is no longer an option, but a necessity for all the companies to implement, especially those that trade in the markets. Quality assurance is essentially the management system that operates to ensure credible results. The prime objective of the field QA program is to maximize accuracy by reducing introduced variability.

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The learning will be gleaned from a quality assurance program that the Director has implemented for the field sampling procedures. This includes collection, labeling, and shipping components. The quality control component of this system is a set of activities intended to control the quality of the data from collection through to analysis. It consists of day-to-day activities such as:

  • The adherence to written protocols; up-to-date and suitable training of personnel
  • The use of reliable laboratories with excellent QA&QC systems in place
  • The regular use of quality control (QC) samples (blanks, standard samples, and field duplicates)
  • Diligent record keeping.

Ricardo will cover the following areas at this seminar:

  • History of the problem, why we need to change the current approach
  • Lineament analysis
  • Lineament analysis and satellite interpretation of data
  • Physical modeling (3D strain analysis and 3D stress analysis)
  • Statistical procedures (Compositional data analysis, correlation analysis, principal component and other methods)
  • Defining a QA/QC program, Blanks, duplicates, standards, external controls
  • Procedures and audits
  • Rock naming in the field
  • Conclusions and recommendations.

Making sense of the FDA’s GMP and Regulatory Expectations for Early IND Products

The FDA’s recent guidance documents covering GMP requirements for Phase I products have considerably reduced some of the complexities early phase products face. These guidance documents are in addition to those that cover the CMC sections for IND submissions at Phase I.

Although these new guidelines appear to remove the need to follow GMPs for Phase I products; the same still exists in the Food, Drug, and Cosmetic Act. As a result, the need for GMP requirements for Phase I products has not been done away with; rather, it has been altered. Now, the nature and extent of GMP-related activities will depend upon the nature of the investigational drug and the extent of the study that is planned.

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Get trained to understand these aspects

GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will be organizing a two-day seminar to help Directors, Managers and Supervisors in Regulatory Affairs, Quality Assurance and Quality Control get a grasp of these aspects. To enroll for this highly valuable training, please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900695SEMINAR?GMP-regulatory-expectations-San-Diego. Steven S. Kuwahara, Founder and Principal, GXP BioTechnology LLC, will be the Director of this webinar.

Advice on the GMP guidance document

This presentation, which has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion, will review the GMP guidance document and discuss how it may be integrated with the recommendations of the guidance documents on CMC requirements. In one source, it will present the regulations and guidelines that apply to early phase products. In some cases these may not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. Steven will present these items in the order of product development from the point of R & D activities to the completion of Phase 2 clinical trials.

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This course is very useful for any pharmaceutical personnel who must deal with products both in early and later phases of development, as it will make them aware of the regulatory requirements that will affect operations dealing with these products. The modifications to the GMPs for early phase products have altered the GMPs in such a way as to reduce requirements to allow more efficient work. At the same time, some of the things that may appear to have changed, have not, and personnel in the pharmaceutical sector should be aware of this. This is the learning that Steven will emphasize at this seminar.

It will cover the following areas:

  • Very Early Stages
  • GLP requirements
  • Early Pre-IND Studies
  • Meetings and Preparing for the IND
  • GMPs for Phase 1 IND products
  • Requirements for Phase 2 INDs
  • Preparing for IND Meetings