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  • 1 Request Info

    Webinar on Common Problems and Mistakes in Method Validation in Drug Development Process

    This webinar provides information that will identify and correct common issues that may arise during validation of methods required in drug development. 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/Common-Problems-and-Mistakes-in-Method-Validation-in-Drug-Development-Process-505094/JULY-2018-ES-TRAININGREGISTRY
  • 2 Request Info

    Webinar on BSA/AML - What is Old is New Again?

    Gain understanding of the current BSA & AML enforcement trends, systemic risks to compliance and getting it right and documentation tips. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/BSA-AML-What-is-Old-is-New-Again-508033/JULY-2018-ES-TRAININGREGISTRY
  • 3 Request Info

    Webinar on Process Validation - Overview of Why and How

    Attend this webinar to gain an understanding of FDA and ISO 13485 requirements for process validation and how to implement them. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Process-Validation-Overview-of-Why-and-How-507096/JULY-2018-ES-TRAININGREGISTRY
  • 4 Request Info

    Webinar on Writing Techniques for Auditors and Risk Management Professionals

    This webinar provides clear guidance on how to translate information into influential thought presented in reports, memos, or whitepapers. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Writing-Techniques-for-Auditors-and-Risk-Management-Professionals-506532/JULY-2018-ES-TRAININGREGISTRY
  • 5 Request Info

    Webinar on Assertive or Aggressive? Assertiveness Skills for Executives, Managers, Supervisors and HR Professionals

    How to communicate more assertively and effectively' A must attend training program for Executives, Managers and HR Professionals. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Assertive-or-Aggressive-Assertiveness-Skills-for-Executives-Managers-Supervisors-and-HR-Professionals-508987/JULY-2018-ES-TRAININGREGISTRY
  • 6 Request Info

    Webinar on Is my Documentation meeting Medical Necessity?

    Learn how to document the medical records to support medical necessity and how to avoid common errors that invariably trigger medical record audits. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Is-my-Documentation-meeting-Medical-Necessity-509484/JULY-2018-ES-TRAININGREGISTRY
  • 7 Request Info

    Webinar on Writing an Effective SAR Narrative

    This webinar will provide a comprehensive review on how to prepare a SAR narrative. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Writing-an-Effective-SAR-Narrative-509578/JULY-2018-ES-TRAININGREGISTRY
  • 8 Request Info

    Clinical Data Management Seminar 2018 | Reasons and The Requirements

    This seminar is based on the current state of regulations and will cover the essential parts of the data management plan, study startup, study conduct, study closeout and study monitoring. A data management plan or DMP is a formal document that outlines how data are to be handled both during a research project, and after the project is completed. The goal of a data management plan is to consider the many aspects of data management, metadata generation, data preservation, and analysis before the project begins; this ensures that data are well-managed in the present, and prepared for preservation in the future. Attendees will be able to: Define best practices as they apply to CDM processes Describe CDM processes from study start-up to database lock Apply best practice rationale when assessing data collection requirements/instruments Evaluate the benefits of standardization in establishing CDM processes Discuss current technology/methods of data collection and associated documentation
  • 9 Request Info

    Data Integrity: Learn to Comply with the FDA Expectations and Avoid Facing Penalties ranging from Public Warning Letters to Criminal Charges and Produ

    This seminar addresses the integrity of GxP records and data used within the regulated industries including pharmaceutical, biological, medical devices, cosmetics, food and any other industry where data integrity is important. It provides a method for managing risk to record and data integrity. Learning objectives for the seminar include: data integrity Requirements Critical Areas of Regulatory Focus and Concern Key Concepts A Framework for data integrity and Human Factors A Complete Data Life Cycle Approach as Part of a Quality Management System, from Creation to Destruction How to Apply Risk Management to data integrity
  • 10 Request Info

    Examination of Laboratory, Medical and Device issues including Performance, Risk and Validation following Regulatory and ICH Statistical Guidelines

    Upon completing this course participants should be able to: Evaluate linear quantitative measurement procedures and sources of error. Distinguish the difference between confidence and tolerance intervals Evaluate the appropriateness of the effect of sample size in given procedures. Evaluate laboratory/clinical quality control based on risk management Interpret statistical process control Distinguish between FDA requirements and ICH guidelines
  • 11 Request Info

    A Risk Based Approach to Excel Compliance with the FDA's 21 CFR 11 and the European Annex 11

    This seminar gives guidance on how to achieve compliance for Excel spreadsheets and other end user applications, such as small databases, in a GxP environment. While the examples given in this seminar are mainly spreadsheets, the same principles can be applied to other end user applications. Spreadsheets are available for creating a wide range of end user applications, including customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used for GxP regulated activities, and they present particular compliance challenges, as they are not originally designed for the regulated environment.
  • 12 Request Info

    Prepare Your Company to Comply with the New FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods

    Prepare Your Company to Comply with the New FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods In this two-day workshop conference, you will learn the legal requirements, how to develop a company plan that meets FDA and your customer requirements. You will review and learn how to establish appropriate temperature monitoring, sanitation, container test and traceability, training and data reporting procedures. New low-cost GPS enabled traceability and temperature monitoring technology, EPA approved container sanitizers, washout technologies, temperature maintenance equipment, and food residue and bio-contaminant testing will be presented. The session will also review the future of transportation food safety in light of new and evolving technologies. References to upcoming technology providers and Internet links to detailed information will be provided.
  • 13 Request Info

    FDA's Software Monsters Seminar | Cybersecurity Course 2018

    Course "FDA's Software Monsters: Cybersecurity, Interoperability, Mobile Apps and Home Use" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Topics: FDA's risk-based regulatory strategy Cybersecurity Interoperability National Institute of Standards and Technology Voluntary standards and programs Mobile Apps Premarket software validation and design requirements Postmarket Software recalls
  • 14 Request Info

    Fundamentals of Statistical Design for Clinical Trials

    This 2-day seminar includes an overview of the need for clinical research, types of clinical trial designs, common statistical tests, considerations of sample size, and randomization techniques. The role of statistics in clinical trials incorporates the tools used to develop a robust study, minimize bias, and assess efficacy of new treatments as relates to efficacy and comparison to competing therapies. Prior to the use of experimental research, clinicians often used subjective measures and anecdotal evidence of treatment efficacy. Concepts such as variability among individuals and treatments were not considered in early applications.
  • 15 Request Info

    Validation and 21 CFR Part 11 Compliance of Computer Systems

    This hands-on course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with Computer Systems Validation as follows: What is 21 CFR 11/Annex 11 and Computer Systems Validation and how is it implemented How to use Risk Based Assessments to reduce work while still achieving Data Integrity and Compliance? Data Integrity Frequently Asked Questions Validation Master Plan Risk Based Assessment Complete Validation for a System (software development lifecycle) Equipment Qualification Infrastructure Requirements Change Control SOPs
  • 16 Request Info

    21 CFR Part 11 compliance for software validation, data integrity and SaaS/Cloud

    Course Objectives: Understand what is expected in Part 11 and Annex 11 inspections Avoid 483 and Warning Letters Learn how to buy COTS software and qualify vendors. Implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds Requirements for local, SaaS, and cloud hosting How to select resources and manage validation projects "Right size" change control methods that allows quick and safe system evolution Minimize the validation documentation to reduce costs without increasing regulatory or business risk Write test cases that trace to elements of risk management Protect intellectual property and keep electronic records safe
  • 17 Request Info

    European Medical Device Regulation / key changes overview

    Europe's new Medical Devices Regulation 2017/745 (MDR) takes effect in May-2020. That seems like plenty of time, but smart companies should start planning their CE transition strategy right away. With manufacturers all over the world transitioning to the MDR and ISO 13485:2016 in the next few years, Notified Body staff shortages and work backlogs are likely to cause delays. This two-day seminar will provide you insights that allow you to identify the best transition strategy for your company based on your product range, certification cycle, markets you serve, and your Notified Body.
  • 18 Request Info

    Design of Experiments (DOE) for Process Development and Validation

    This course will begin by presenting a primer on statistical analysis, focusing on the methods required for analysis of designed experiments. It will then present the steps to DOE, while demonstrating valuable risk management tools (Ishikawa and FMEA) which can be use pre and post DOE studies. Next, participants will learn to generate and analyze multiple screening and response surface designs; the participants will leave with an understanding of why and how each are used. Then, the participants will learn how results of the studies can be presented. Lastly, using the results of the studies, the risk management tools will then be updated. http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901633SEMINAR?trainingregistry
  • 19 Request Info

    Clinical Evaluation Report for Europe and MEDDEV Expectations: Impact with New Medical Device Regulations (MDR)

    Course "Clinical Evaluation Report for Europe and MEDDEV Expectations: Impact with New Medical Device Regulations (MDR)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Clinical Evaluation Report and MEDDEV Consulting Case Study Practice Case Study Practice Interactive Exercises and Discussions Questions and Summary Venue: Hilton Zurich Airport, Zurich, Switzerland https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901861SEMINAR?trainingregistry
  • 20 Request Info

    Webinar on USPAP Issues & Best Practices for Residential Appraisal Reviewers: Avoiding Violations

    The webinar includes a brief overview of the Interagency Appraisal and Evaluation Guidelines and its requirements for appraisal reviewers and what agencies enforce USPAP. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/USPAP-Issues-Best-Practices-for-Residential-Appraisal-Reviewers-Avoiding-Violations-508477/JULY-2018-ES-TRAININGREGISTRY