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Courses

  • 1 Request Info

    21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

    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.
  • 2 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
  • 3 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.
  • 4 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.
  • 5 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.
  • 6 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.
  • 7 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.
  • 8 Request Info

    6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

    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. FDA’s 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed.
  • 9 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.
  • 10 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.
  • 11 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.
  • 12 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.
  • 13 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.
  • 14 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
  • 15 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
  • 16 Request Info

    Audit Like the FDA - How to develop and implement an efficient and effective audit program

    This 2 day seminar will explore how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance. A well-designed audit program can be an effective tool in understanding, communicating, and reducing quality and compliance risk. However, estimates indicate that up to 75% of companies conduct audits only because they are required to by regulation. Businesses often see internal audit as a non-value added activity leading to meaningless findings, bureaucracy, and cumbersome processes. And despite having an internal audit program, management is often surprised when they receive a 483, Warning Letter, or even a Consent Decree. A well planned audit program can reduce these risks.
  • 17 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
  • 18 Request Info

    AutoCAD 2008 3D Drawing & Modeling

    For other AutoCAD classes and outlines please visit AutoCA D training .More and more AutoCAD users are venturing out of their traditional and familiar two-dimensional world of 3D space.
  • 19 Request Info

    AutoCAD 2008 Advanced

    For other AutoCAD classes and outlines please visit AutoCA D training .This course is suitable for students comfortable with the basics of creating an AutoCAD drawing.
  • 20 Request Info

    AutoCAD 2008 Fundamentals

    For other AutoCAD classes and outlines please visit AutoCA D training .The objective of AutoCAD 2008 Fundamentals is to enable students to create a basic 2D drawing in AutoCAD.