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  • 81 Request Info

    How to Audit Against ICH GCP 2 Addendum to Ensure Compliance

    Overview: It is important GCP Auditors to understand how to audit the changes required by the new ICH GCP R2 Addendum. To consider how audit checklists and procedures should have been updated to ensure the new requirements are met and their organisations are ready for regulatory inspection. The session will also include an update on the proposed further major revision of ICH GCP R2 planned by ICH to start later next year. The new guideline includes a number of "hot" GCP inspection topics which are also covered in a number of other EU and FDA guidelines and documents, such as risk-based approaches for running clinical trials. These new approaches are going to be areas inspectors will be focussing on.
  • 82 Request Info

    How to be efficient and compliant with 21 CFR Part 11

    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.
  • 83 Request Info

    How to Comply with 21 CFR 11 Requirements

    In this webinar you will learn how to Manage site and sponsor interactions with regards to EMR, and What are source documents and why are they important? (FDA and ICH GCP E6 Guideline), How EMR Data is used in Clinical investigations, and What are future expectations for EMRs (FDA Draft Guidance) and the impact on sponsors and sites.
  • 84 Request Info

    How to Identify the Causes Behind the Autism Spectrum Disorder

    Overview: This is an interactive overview of how DMAIC can be utilized in a home environment to improve the quality of life for a child diagnosed as being on the Autism Spectrum. Why should you Attend: The same tools and skills can be applied to any other form of personal or professional issue. This session rated first at the ASQ WCQI conference when it was presented there. It leaves people motivated and refreshed with a plan of how to manage systems with a toolkit that they can easily apply.
  • 85 Request Info

    How to Prevent Making Mistakes

    We all make mistakes. Sometimes they are of little consequence. Other times they can impact and shape a career or bottom line. In this fast-moving training, attorney, author and speaker, Don Phin, will share with us what he learned on his deep dive into why we and others make mistakes, and what to do about them when they do surface. For example, have you ever assumed too much? Or come in unprepared? Are we ignoring the elephant in the room or under-estimating a risk? Do we fail to connect the dots or succumb to groupthink?
  • 86 Request Info

    How to Validate and use Excel Requirements

    Overview: Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel® has not been designed for regulated environments.
  • 87 Request Info

    HPLC Analytical Method Development

    Overview: Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals is also an area of focus in an audit.
  • 88 Request Info

    Human Error Reduction in the Manufacturing Floor 2018

    Overview: Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.
  • 89 Request Info

    Human Factors Psychology Graduate Programs | Human Factors 2018

    The ISO 62366 is an "Consensus" Standard, making it a gold standard for regulatory submissions. We will look at other reference points regarding HF, like AAMI/ANSI HE75:2009 and how HF Engineering include consideration of: Device Users Use Environments and User Interfaces Preliminary Analyses Exploratory HF/Usability Evaluations Hazard Mitigation and Control We will look at the implication of HFE through Design Controls in the QSR: Design input -includes "needs of the user and patient" Design validation - "... devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software Read More:
  • 90 Request Info

    Hydraulic Fracturing

    This 5-day course emphasizes the multi-disciplinary nature of hydraulic fracturing, covering the "Reservoir Engineering" aspects, integrated with the "Fracture Mechanics" aspects, and coupled with "Operational" considerations. This integration is absolutely necessary in order to present how to recognize opportunities for fracturing from hard rock tight gas, to offshore "frac-pack" completions, to multi-fractured horizontal shale wells. Also covered is how to estimate required data for planning and preparing preliminary job designs, how to design, perform, and analyze pre-frac tests, and finally how to arrive at an "optimum" final design. Along with an Introduction to Fracturing, the course covers Reservoir Response, Rock Stresses, Fracture Geometry, Fracture Pressure Analysis, Fracture Fluid & Proppant Selection, Multi - Fractured Horizontal Wells, and Field Application & Quality Control. Instructor: Carl Montgomery, NSI Technologies
  • 91 Request Info

    Implementing ISO 14001:2015

    If you intend to comply with ISO 14001:2015 or become registered to ISO 14001:2015 this class will help you understand the ISO 14001:2015 requirements, proceed in a timely and cost effective manner, take advantage of the existing management structure that exists in your organization, and leverage any existing environmental compliance program. Note: This course is based on case studies and examples relative to government.
  • 92 Request Info

    Importance of Dissolution Testing | Plasma Levels of Drug 2018

    Drug dissolution testing is an essential and critical step for appropriate and efficient product development such as tablet and capsule. A number of approaches are used to conduct dissolution testing using different apparatuses and methods. Making a choice for an appropriate apparatus and method has always been confusing and challenging. This seminar will provide relevant pharmacokinetics and physiological background so that making this choice becomes easier and instinctive. No prior knowledge of pharmacokinetic and/or physiology is required; however, these will be explained in very simple terms to help attendees in selecting or developing a dissolution method. This seminar will describe in detail the theoretical aspect of the drug dissolution testing including method development. Pros and cons of different approaches will be explained in detail. Read More:
  • 93 Request Info

    Improve Your IRS Compliance: Use Best Practices for TIN Solicitation

    While TIN (taxpayer identification number) solicitation might sound too lascivious for the legitimate business world, it is critical that every organization take this task seriously. For if they don't, a very uncomfortable and costly audit with the IRS is likely to ensue. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 94 Request Info

    Industrial Electrical Training Video Library

    Industrial electrical training video course, 10 DVDs about electrical control with video reference handbook, instructor's guide, answer key, master set of exams and course completion certificate.
  • 95 Request Info

    Industrial Electronics with PLC Technology

    Earn an accredited diploma in PLC technology. Instructor support, graded exams & student resources. Send for your FREE course catalog.
  • 96 Request Info

    Industrial PLC Training Video Course

    Industrial PLC training video course, 10 DVDs about Programmable Controllers with video reference handbook, instructor's guide, answer key, master set of exams and course completion certificate.
  • 97 Request Info

    Industrial Technical Trainer Certification

    Day one of the workshop will build the foundation for effective adult learning particularly in terms of adult learning theory and human performance. This is fundamental to understanding how to best transfer job relevant skills and knowledge to adult learners. Day one will end with a discussion of the building blocks of training - those skills needed to break training into manageable parts. Click to Continue Reading:
  • 98 Request Info

    Intro to Programmable Logic Controllers Course with MicroLogix Software

    What is included? 2 textbooks, 2 CDs, Quizzes, MicroLogix Programming Sofware 48 hands-on labs and exercises! Complete course: $130
  • 99 Request Info

    Introduction to Measurement & Calibration – Online

    An easy to access, menu driven curriculum allows the learner to concentrate on the topics specific to their job requirements. For anyone taking measurements, new hires, students or a refresher for technicians. A logon feature and a printed final test result provides required documentation of training.
  • 100 Request Info

    Introduction to Measurement and Calibration

    QC Training Services’ Introduction to Measurement and Calibration is designed to introduce the metrology and calibration technician and other personnel to the field of metrology. Metrology vocabulary, principles, domains, concepts, and processes are discussed. This first day covers the need for good measurements, principles of metrology, fundamental and derived units, measurement terminology, traceability, dimensional metrology, physical metrology measurements, temperature measuring instruments, and calibration. The second day covers electrical metrology terms, calculations, document standards, calibration systems, and measurement uncertainty. The introduction reviews standards, principles and devices used in measurement and the specific applications of each. Calibration is a key component of ensuring your measurement system is accurate, and we’ll cover the methods, procedures and environments for an effective calibration system.