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  • 1 Request Info

    21 CFR Part 11 compliance for software validation and SaaS/Cloud 2017

    This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers. The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation. Today the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements
  • 2 Request Info

    A Six Sigma Approach to Achieving Project Management Quality

    Learn how to achieve greater internal efficiency to help manage project costs, keeps projects on schedule, align with corporate strategy, put the right people on the right projects, meet customer quality requirements, generate successful project outcomes
  • 3 Request Info

    Advanced Product Quality Planning (APQP)

    OBJECTIVES:This Advanced Product Quality Planning (APQP) class is a comprehensive introduction to the APQP process – its planning, strategy and benefits. Learn the structure and information sources for effective use of APQP and its correlation to the rest of the AIAG core tools. TARGET AUDIENCE: Anyone involved in any aspect of automotive product quality planning, including management, sales, engineering, quality, purchasing, and manufacturing. Prerequisite: It is desirable but not absolutely necessary that participants should have some degree of basic understanding of FMEA, SPC and other continuous improvement tools. Participants will learn the general application of the APQP process, its five distinct phases and correlation to the P-D-C-A cycle. Understanding the inputs and outputs of each phase will lead to improved communication within your company and your customers. The Automotive Industry Action Group (AIAG) APQP training manual is used for this class.
  • 4 Request Info

    Advanced Statistical Process Control

    COURSE SUMMARY In this Advanced Statistical Process Control course, students will study effective methods to remove guesswork from quality metrics, eliminate or reduce inspection levels, and increase overall knowledge to improve the production process. COURSE OBJECTIVES This workshop is a follow-up to our Basic SPC course. You will expand your fundamental understanding of Statistical Process Control by discovering new tools and methods taught in this course.
  • 5 Request Info

    Advanced Tools and Techniques for Data Analysis

    This 2-day advanced analytics seminar will introduce you to predictive analytics techniques, so you can frame strategic and operational questions involving marketing, finance, and operations or other real-world business applications.

    In this hands-on course, you will cover a variety of analytics tools, such as histograms, ANOVA analysis, A/B testing, Pareto analysis, clustering, box plots, scatter diagrams, partitioning, unstructured text analysis, and multivariate regression analysis. Best of all, no background in statistics or programming is required. As long as you have a basic understanding of spreadsheets, you will learn how to manipulate complex data sets so you can gain insights that are not possible with common business intelligence techniques.

  • 6 Request Info

    Applied Statistics for Business Analytics Applications

    This course is intended for those who need practical skills and knowledge in using statistical tools and techniques for Business Analytics (BA) applications—or so-called “Exploratory Analysis.” The course will emphasize where and when the tools and procedures apply, including the inputs they rely on, as well as the end-results—or outputs—they produce. The tools and techniques will be introduced from the standpoint of their practical utility as well as the outputs they are capable of producing, rather than their mathematical structure or derivation. Hands-on exercises will be used to reinforce learning by taking advantage of the built-in statistical functions in MS Excel.
  • 7 Request Info

    Applied Statistics for Scientists and Engineers

    This course provides instruction on how to apply the appropriate statistical approaches: descriptive statistics, data intervals, hypothesis testing, ANOVA, regression, ANCOVA, and model building. Once competence in each of these areas is established, industry-specific applications are presented for the participants.
  • 8 Request Info

    ARC002 - ARC's Planning & Conducting Operational Audits: The Comprehensive Audit

    This is the Real Deal. This hands-on program is for experienced business professionals who want to see their organizational units in a completely new light. The focus on effective and efficient Operational (Process) Audits is more critical now than ever. With individuals challenged with the efficient, effective, and economical use of resources, you need the tools to quickly analyze key business processes to ensure they are providing the expected return.This comprehensive program gives you these tools to evaluate the critical environments of your organization essential for the enhancement of shareholders’ wealth. You’ll learn how to project the impact of proposed changes to the gains in shareholders’ wealth, determine the best use of limited funds, identify cash leakages, and much more.
  • 9 Request Info

    AS9100 Accredited Internal Auditor

    This program has been designed to meet the training requirements for internal auditors for Management Systems. It is accredited by ANSI (American National Standards Institute) and provides training in the principles and current interpretation of the requirements as related to Management System standards and the ISO 19011 audit guideline document. This course is accredited by the American National Standards Institute. Upon successful completion you may claim to be a certificate holder for AS9100 3-Day Internal Auditor. (You may not claim to be a certified person.)
  • 10 Request Info

    AS9100 Certified Lead Auditor

    This course will present the principles and practices of auditing of aerospace quality management systems as related to AS9110:2012 and ISO 19011. This course is certified in the Exemplar Global (formerly RABQSA) Certification Program, and along with the IAQG Aerospace Auditor Transition Training, meets the training portion of the requirements for certification of individual AS9110:2012 Quality Systems Auditors. Successful completion will allow the attendee to perform all aspects of an audit of a process in accordance with ISO 19011, including audit planning, document review, use of checklists, opening and closing meetings, sampling, note-taking, objective evidence, audit team meetings, classification of nonconformities, communication and documentation of nonconformities and observations, audit reporting, and record keeping.
  • 11 Request Info

    AS9100, AS9110 & AS9120:2016 Auditor Transition Training

    This course is intended for auditors (external and internal auditors). It will cover the specific differences between the AS9100/AS9110/AS9120:2009 requirements and AS9100/AS9110/AS9120:2016 requirements from an auditor’s perspective. This course will emphasize the concepts that will be difficult to audit, including new requirements that are less prescriptive—for example: requiring fewer procedures, QMS-based risk based thinking in addition to operational risk management, knowledge management, product safety, counterfeit parts prevention, and many others. Because both AS9100/AS9110/AS9120:2016 Auditor Transition Training and AS9100/AS9110/AS9120:2016 The Path Forward deal with changes contained in the 2016 revision of the standard, there is inevitable overlap in course content. While many may choose to take both sessions, some choose one or the other making this overlapping content necessary.
  • 12 Request Info

    AS9100, AS9110 & AS9120:2016 Risk Management Essentials and Implementation Strategies

    This course provides coverage of both the system-level risk based thinking (risks and opportunities) and the more formal operational risk management requirements within AS9100/AS9110/AS9120:2016, as well as the implications these requirements have for your organization. It will include the steps necessary to demonstrate that both the system-level and operational risk requirements requirements have been met and also return value to the organization. This course is intended for those who will be using AS9100/AS9110/AS9120:2016 and need to understand the two risk management requirements contained within the standard.
  • 13 Request Info

    AS9100, AS9110 & AS9120:2016 The Path Forward

    This course is intended for management at all levels, quality personnel, and others who need to understand the requirements of AS9100/AS9110/AS9120:2016; what the requirements mean for their organization, and the steps their organization must take to update their current QMS to meet the requirements of AS9100/AS9110/AS9120:2016. At the end of this course, each participant will leave with a formal, documented, detailed plan that is specific to the needs of their organization. This plan will provide the details you will need to move your organization forward to accomplish two objectives: *Meet the requirements of AS9100/AS9110/AS9120:2016 and provide evidence that requirements have been met. *Achieve the embedded benefits contained in AS9100/AS9110/AS9120:2016. Benefits will focus on the organization and their customers.
  • 14 Request Info

    AS9110 Certified Lead Auditor

    This course will present the principles and practices of auditing of aerospace quality management systems as related to AS9110:2012 and ISO 19011. This course is certified in the Exemplar Global (formerly RABQSA) Certification Program, and along with the IAQG Aerospace Auditor Transition Training, meets the training portion of the requirements for certification of individual AS9110:2012 Quality Systems Auditors. Successful completion will allow the attendee to perform all aspects of an audit of a process in accordance with ISO 19011, including audit planning, document review, use of checklists, opening and closing meetings, sampling, note-taking, objective evidence, audit team meetings, classification of nonconformities, communication and documentation of nonconformities and observations, audit reporting, and record keeping.
  • 15 Request Info

    Auditing and Inspecting Preclinical Research for GLP Compliance

    The Good Laboratory Practice (GLP) guidelines have progressed through various transitional phases to become guidelines in some countries and regulatory/statutory instruments in others. The objective of the GLPs is to ensure that a standard approach is undertaken, covering traceability and accountability of medical research and drug development process. This webinar discusses various aspects of auditing and inspecting preclinical research compliance with GLP. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Auditing-and-Inspecting-Preclinical-Research-for-GLP-Compliance-503774/DECEMBER-2017-ES-TRAININGREGISTRY
  • 16 Request Info

    Auditing to ISO 17025

    Those wanting to become knowledgeable in ISO/IEC 17025 requirements, and/or want to become qualified in performing internal audits should attend. This class is attended by both potential assessors and personnel from laboratories seeking accreditation. Attendees seeking to apply the information from the course to their respective laboratory should be familiar with their laboratory’s technical operations in order to fully benefit from the course in their pursuit for ISO/IEC 17025 compliance. Our Auditing to ISO 17025 course is designed to enable you to develop a solid understanding of the ISO/IEC 17025 standard and be able to audit your laboratory to the standard.
  • 17 Request Info

    Auditor / Lead Auditor Training for ISO 9000 With guidance on ISO 9000:2000 IRCA/IATCA/RAB

  • 18 Request Info

    Basic Dimensional Measurement Tools (BDMT)

    QC Training Services's Basic Dimensional Measurement Tools and Methods (BDMT) class is an introduction to some of the most common gages used on the shop floor. The purpose is to provide practical instruction on the different tools available and their proper use to build workers' skill and knowledge.This program provides a fundamental and practical review of Basic Dimensional Measurement Tools and Methods, including variable gages such as steel rules, depth and dial gages, micrometers, and calipers. In addition, attribute gages such as plug, ring and screw thread gages are covered. Basic Dimensional Measurement Tools and Methods builds a solid foundation of skills that workers can use across a broad spectrum of applications. It forms the basis for mastering more advanced measuring tasks to ensure that you’ll get the most accurate measurements possible.
  • 19 Request Info

    Basic Statistical Process Control (SPC)

    Basic Statistical Process Control (SPC) is an introduction to statistics and the data collection process. The purpose is to provide practical instruction on the fundamental statistical tools used in modern process control methods, including the purpose, concepts and parameters associated with control charts and process capability. Participants will study effective methods to remove guesswork from quality metrics, eliminate or reduce inspection levels, and increase overall knowledge to improve production processes. Learn the different tools used to analyze data, approaches for variable vs. attribute data, as well as performance vs. capability.
  • 20 Request Info

    Biotech/Biosimilar Products: Current and Emerging Analytical CMC Expectations

    Learning Objectives: Recognize the system of worldwide regulatory guidance applicable to biotech and biosimilar product CMC requirements Understand why requirements for biotech products are so different from those of chemical products Find exactly ‘where it is written’ for current and emerging CMC expectations for biotech/biosimilar products, and get copies of those regulatory documents See how to implement a staged approach to establishing specifications for release and stability testing Learn the current analytical technologies used for establishing biotech/biosimilar product characteristics and assessing comparability Select the appropriate methods for release and stability testing Design suitable qualification and validation exercises for method intended uses Establish stage-appropriate ICH stability protocols Learn the tiered approach for managing product reference standards Recognize how much R&D data are exposed to regulatory scrutiny