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Courses

  • 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

    21 CFR Part 11 Guidance for Electronic Records - 2018

    Overview: 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. Why should you Attend: This webinar will help you understand in detail the application of FDA's 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do.
  • 3 Request Info

    21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

    All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device manufacturing plants, required to follow 21 CFR Part 820, have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by controlled records. Prior to computer systems and databases, managers and quality personnel created complex visual numbering schemes, cross-referencing methods and complex filing systems for purposes of retrieval and control. These grew over the years into the extremely complex and convoluted systems we find today throughout the life sciences, including the medical device industry.
  • 4 Request Info

    3ds Max 2008 Fundamentals

    For other AutoCAD classes and outlines please visit AutoCA D training . Autodesk 3ds Max is one of Autodesk's design visualization platforms.
  • 5 Request Info

    3ds Max Design 2009 Fundamentals

    For other AutoCAD classes and outlines please visit AutoCA D training . Autodesk 3ds Max Design is Autodesk's premier design visualization platform.
  • 6 Request Info

    3ds Max Design 2010 Fundamentals

    For other AutoCAD classes and outlines please visit AutoCA D training . Autodesk 3ds Max Design is Autodesk's premier design visualization platform.
  • 7 Request Info

    AB RSLogix PLC Training

    Business Industrial Network provides on-site Allen- Bradley Programmable Logic Controller (PLC) troubleshooting training as well as seminars. (1.6 CEU) Now also free RSLogix 5000 training software to every attendee. No one else comes close to matching the value we offer.
  • 8 Request Info

    AB RSLogix PLC Training Seminar - St. Louis

    Hands-On PLC Training Workshop (PLC: Programmable Logic Controllers). Start with basics move on to troubleshooting, then learn the foundations of good PLC programming while writing your first IEC-1131 compliant PLC program. (1.6 CEU) If you would like to learn how to reduce downtime thru PLC training, please sign up immediately for our 3 day workshop in Saint Louis. (As there is limited seating and these fill up quickly.) Bonus: In addition to every attendee being sent home with extra PLC learning material ... as an additional bonus, we give every attendee our RSLogix 5000 PAC training software for free too! No other provider can come close to the value of this PLC training workshop! So register soon.
  • 9 Request Info

    Advanced Assembly Design and Management

    For other AutoCAD classes and outlines please visit AutoCA D training .This course builds on the assembly functionality introduced in the CATIA V5: Introduction to Modeling course.
  • 10 Request Info

    Advanced Part Design

    For other AutoCAD classes and outlines please visit AutoCA D training .As an experienced user in the basics of CATIA, this course enables you to become more productive and techniques.
  • 11 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.
  • 12 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.
  • 13 Request Info

    Advanced Surface Design

    For other AutoCAD classes and outlines please visit AutoCA D training .This course expands on the knowledge learned in the CATIA.
  • 14 Request Info

    An Advanced Course on Lean Documents, Lean Configuration and Document Control

    In this Lean Documents, Lean Configuration, and Document Control training learn the different types of lean documents and the usage of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents. Pros and cons of lean vs. non-lean documents. Just as a manufacturing process produces a product, controlled documents are the product of a business process. Just as in manufacturing, a product cannot move forward if it is waiting for component parts, a document cannot move forward if it is waiting for information, or if its use is constrained by other documents. Although many life science companies advocate lean manufacturing, lean laboratory, and lean operations, they have cumbersome controlled documents and systems which cause significant operating expenses, and make it difficult to introduce process improvements in a timely manner.
  • 15 Request Info

    Applied Statistics for QA, QC, Manufacturing, and Design Control

    This seminar provides a practical approach to understanding how to interpret and use a standard tool-box of statistical methods, including confidence intervals, t-tests, Normal K-tables, Normality tests, confidence/reliability calculations, AQL sampling plans, measurement equipment analysis, and Statistical Process Control. Without a clear understanding and correct implementation of such methods, a company risks significantly increasing its complaint rates, scrap rates, and time-to-market; and significantly reducing its product and service quality, its customer satisfaction levels, and its profit margins.
  • 16 Request Info

    Applied Statistics for QA, QC, Manufacturing, and Design Control

    The 2-day seminar begins with an examination of ISO and FDA regulations and guidelines regarding the use of statistics. Basic vocabulary and concepts are then reviewed and discussed. The flow of subsequent topics over the 2 days is as follows: • How to calculate confidence intervals (for proportions and for measurements), including a discussion of how to choose sample size • How to perform an interpret t-Tests, including consideration of "significance", "p-values", "power" and sample-size considerations • How to perform calculation of confidence/reliability for attribute data
  • 17 Request Info

    Applied Statistics, with Emphasis on Verification, Validation, Sample Size, and Risk Management, in R&D, Manufacturing, and QA/QC

    The 2-day seminar explains 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: 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
  • 18 Request Info

    ARC003 - ARC's Cost Accounting Level I: Cost Concepts for the Profit-Oriented Organization

    This program will give you a clear and concise grasp of the basics of cost accounting. You won’t find a better program for developing a system that meets your cost accounting needs. Now you can understand what it really costs you to deliver a product and maximize profitability at the same time. The most successful organizations truly understand the cost of their operations including plant operations, supply stream management, joint and by-product costs, inventory management, and impact of overhead on specific product lines. You’ll learn how to develop budgets and standards, track and determine the true causes of variances, and use the cost information as a profit enhancement tool Also, you will learn how to determine pricing for goods and services and make the best use of people, money and materials.
  • 19 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.)
  • 20 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.