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  • 1 Request Info

    21 CFR Part 11 Compliance Checklist- FDA Software Validation

    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. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901525SEMINAR?trainingregistry-March-2018-SEO
  • 2 Request Info

    21 CFR Part 11 Compliance for Computer Systems Regulated by FDA 2017

    The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901297SEMINAR?trainingregistry-November-2017-SEO
  • 3 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
  • 4 Request Info

    AB RSLogix PLC Training Seminar

    You will receive hands on training with the lap top using RS Logix and your pick of the PLC5, or a SLC500 or a Micrologix PLC. Day 3 is the challenge workshop, a chance to exercise your newly learned skills.(1.6 CEU) Plus free PLC, trainer, 1 gig extra learning material and free copy of RSLogix 5000 training software to every attendee. No one comes close to matching the value we deliver.
  • 5 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.
  • 6 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.
  • 7 Request Info

    Allen Bradley RSLogix PLC Training

    Reduce downtime thru PLC training.You will get hands on training with the lap top using RS Logix and PLC5, SLC500 and Micrologix PLC. This course qualifies for 1.6 CEU and you receive a certificate, a free PLC and other training resources like the software simulation CD. Now also free RSLogix 5000 training software to every attendee. No one else comes close to matching the value we offer.
  • 8 Request Info

    Applied Statistics for FDA Process Validation 2017

    In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage through commercial production.." The guidance further delineates the 'process design stage through commercial production' into three distinct stages of the product lifecycle: Stage 1: Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities. Stage 2: Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900806SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 9 Request Info

    Applied Statistics for Scientists and Engineers

    Throughout 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries, the application of statistical methods are specified for: setting validation criteria and specifications, performing measurement systems analysis (MSA), conducting stability analysis, using design of experiment (DOE) for process development and validation, developing process control charts, and determining process capability indices. Different statistical methods are required for each of these particular applications. Data and tolerance intervals are common tools used for setting acceptance criteria and specifications. Simple linear regression and analysis-of-covariance (ANCOVA) are used for setting expiries and conducting stability analysis studies. Two-sample hypothesis tests, analysis-of-variance (ANOVA), regression, and ANCOVA are methods used for analyzing designed experiment for process development and validation studies. Descriptive statistics (distribution
  • 10 Request Info

    Applied Statistics for Scientists and Engineers 2017

    Throughout 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries, the application of statistical methods are specified for: setting validation criteria and specifications, performing measurement systems analysis (MSA), conducting stability analysis, using design of experiment (DOE) for process development and validation, developing process control charts, and determining process capability indices. Different statistical methods are required for each of these particular applications. Data and tolerance intervals are common tools used for setting acceptance criteria and specifications. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901138SEMINAR?trainingregistry-December-2017-SEO
  • 11 Request Info

    Applying ISO14971 and IEC62304 | Risk Management Seminar 2018

    Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management.
  • 12 Request Info

    ARC005 - ARC's Fundamentals Finance & Accounting for Non-financial Professionals

    This is for those who are new to management or who need to understand and use financial statements. You will learn how to Talk the Talk and Walk the Walk. From how the statements work, to how to read them, to how to calculate the ratios that provide meaning. for new managers, purchasing and sales professionals and anyone who needs to communicate with those accountants.
  • 13 Request Info

    ARC011 -ARC's Financial Modeling & Forecasting Using Excel Course

    Using Excel®, the Financial Modeling and Forecasting process provides an effective tool with which the you and project the potential outcomes of various strategic and tactical initiatives. The ability to answer the question “What are the potential results?” is key and critical. Forecasting models empower mangers and process owners to “Walk the Walk” prior to any significant investment of corporate resources. Using Excel©, you will learn how to calculate the impact time has on future cash flows, how to project the benefit of capital projects, make lease vs. buy decisions, determine the cost of capital, and project EVA©. Also, using Excel©, you will learn how to evaluate organizations with which you are planning to do business; determine if they are able to provide strategic strength to your company. Participants will be provided Excel© templates for use during this session, and when they return to their organizations.
  • 14 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.)
  • 15 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.
  • 16 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.
  • 17 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.
  • 18 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.
  • 19 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.
  • 20 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.