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Courses

  • 1 Request Info

    Creation of DHFs, DMRs, and DHRs utilizing the principles of Lean Documents and Lean Configuration

    The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and "push" systems, many traditional document practices are artefacts of a flawed approach. Lean documents presents a fresh departure from these practices, while building upon proven principles. Lean configuration comes from the same principles, utilizing the unique power of software solutions to take over functions that had previously burdened controlled "paper" documents.
  • 2 Request Info

    Introduction to Design of Experiments

    Design of Experiments is a vital tool for process improvement and root cause analysis. It allows experimenters to determine beyond a quantifiable reasonable doubt that an experiment improves the process, or that there is a difference between treatments; choices among the factors of the cause and effect diagram. While comprehensive mastery of DOE requires full college-level courses, enough basics can be taught in an hour to enable the attendee to know the key considerations in the design of an experiment, and also interpretation of its results. The material on hypothesis testing will also position the attendee to understand statistical process control (SPC) and acceptance sampling.
  • 3 Request Info

    Risk Based Thinking in and Beyond ISO 9001:2015

    ISO 9001:2015's new clause for "actions to address risks and opportunities" is among the biggest revisions to the standard. Risks and opportunities that relate to waste or muda, and also to changes in technology, markets, and distribution channels are however not explicitly covered, and are therefore not explicitly auditable, even under the new standard. This credit risk mitigation presentation will therefore focus on use of the standard as a servant whose purpose is to promote the organization's competitiveness and profitability, rather than a master whose requirements the organization has to satisfy to get the ISO certificate. ISO 9001 becomes the servant when the organization uses it as a framework to drive continual improvement and to identify risks and opportunities that lie well beyond the scope of the standard.
  • 4 Request Info

    Two Days Workshop On Statistical Analysis for Process and Product Development

    This course is designed to help scientists and engineers apply statistical methods used to assist decision making in process and product development. Variability must be considered when utilizing data to arrive at conclusions. This course will cover Basic Statistics and Graphical Methods used to summarize data. You will learn how to apply Hypothesis Testing methods to determine whether groups are statistically equivalent or not with respect to key process characteristics such as process averages and variability. Single Registration :- $1,400.00 http://www.onlinecompliancepanel.com/workshop/STATISTICAL-ANALYSIS-800008/APRIL-2016-ES-TRAININGREGISTRY
  • 5 Request Info

    Webinar On 21 CFR Part 11 - Electronic Record and signature Validation

    This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records will be explained.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/webinar/21-CFR-PART-11-ELECTRONIC-RECORD-SIGNATURE-VALIDATION-501462/JUNE-2016-ES-TRAININGREGISTRY
  • 6 Request Info

    Webinar On Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

    This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/TECHNICAL-WRITING-PHARMACEUTICAL-MEDICAL-BIOTECH-501535/JUNE-2016-ES-TRAININGREGISTRY
  • 7 Request Info

    Webinar On Process Validation - Current Industry Practices and FDA Guidance Document Review

    Process validation is an important subject for the pharmaceutical quality or regulatory professional. Process validation can be difficult and can cause confusion due to different standards, approaches, and process complexities. In this webinar, the basics of process validation will be explored along with current industry practices. The recent draft FDA Guidance Document on process validation will be reviewed and case studies will be presented that will allow the attendee to see practical examples of process validation protocols.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/PROCESS-VALIDATION-FDA-GUIDANCE-501491/JULY-2016-ES-TRAININGREGISTRY
  • 8 Request Info

    Webinar On Using Analysis of Variance(ANOVA) - A Practical Approach

    This webinar provides a powerful statistical tool called Analysis of Variance (ANOVA) that you can use to analyze data and improve processes. Because the tool is available in Excel, you don't need to purchase an expensive complicated software package. It is already available to you.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/USING-ANALYSIS-VARIANCE-ANOVA-501564/JULY-2016-ES-TRAININGREGISTRY
  • 9 Request Info

    Webinar On Identifying and Addressing Cybersecurity Risks for Medical Devices

    Reports of cybersecurity attacks are appearing more and more frequently in the news affecting e-commerce, retail, the financial industry, the power grid, and in the healthcare setting. With more devices connected as part of the internet of things (IoT), the risks and number of potential threats increases exponentially. Connected medical devices present a unique set of risks due to the element of patient safety and potential for catastrophic outcomes.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/webinar/CYBERSECURITY-RISKS-MEDICAL-DEVICES-501617/JULY-2016-ES-TRAININGREGISTRY
  • 10 Request Info

    Webinar On Risk Based Approach for Medical Device Design Control

    This course will explain how to manage a Design Control program that will meet FDA requirements and minimize chances of your medical device being recalled. Such a program will also help to get projects completed on time and within budget. The important and confusing question of when, in a development process, Design Control begins will be answered. The difference between pre-release and post release change control will be explained.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/RISK-BASED-APPROACH-MEDICAL-DEVICE-DESIGN-501511/AUGUST-2016-ES-TRAININGREGISTRY
  • 11 Request Info

    Webinar On FDA Regulation of Digital Health - Current Status and Recent Developments

    Why is the FDA focusing on Digital Health? Many medical devices now have the ability to connect to and communicate with other devices or systems. Devices that are already FDA approved or cleared are being updated to add digital features.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/webinar/FDA-REGULATION-DIGITAL-HEALTH-501646/AUGUST-2016-ES-TRAININGREGISTRY
  • 12 Request Info

    Webinar On Key Success Factors to reduce your risk of FDA Citations

    Does your company have the symptoms of a sick Quality System? This webinar will help you recognize the symptoms. You will learn about the risks and what you can do about them. Learn from an industry expert how you can improve your Quality Management System.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/RISK-FDA-CITATIONS-501812/OCTOBER-2016-ES-TRAININGREGISTRY
  • 13 Request Info

    Webinar On Risk Management Using ISO 14971:2007 and EN ISO 14971:2012

    Risk management is essential to device design and required by other standards, such as usability engineering, biocompatibility and electrical safety. The basis is ISO 14971:2007, but many companies don't understand the standard, don't follow the process flow, and consequently don't have an effective implementation. This presentation helps you avoid the common problems and create a compliant system.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/ISO-14971-2007-501829/DECEMBER-2016-ES-TRAININGREGISTRY
  • 14 Request Info

    Webinar On Acceptance Sampling Plans for Process Validation and Production Lot Monitoring

    This webinar will cover acceptance sampling plans for process validation and production lot acceptance. Sampling plans for attribute data are the primary focus although variable acceptance sampling plans are presented as well. The binomial distribution and its use in developing Operating Characteristic (OC) curves will be discussed.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/webinar/PROCESS-VALIDATION-PRODUCTION-LOT-MONITORING-501949/JANUARY-2017-ES-TRAININGREGISTRY
  • 15 Request Info

    Webinar On How to Conduct a Human Factors Validation Test Following ISO62366 and the FDA Guidance

    Validation testing aims to show that a device can be used by the intended users without serious use errors or problems, for the intended uses and under the expected use conditions. This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation test. HF/U validation is very different from device validation.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/HUMAN-FACTORS-VALIDATION-ISO62366-FDA-502041/FEBRUARY-2017-ES-TRAININGREGISTRY
  • 16 Request Info

    Workshop On Quality Audits for the Medical Device Industry

    Quality audits are an important element in implementing and maintaining an effective Quality Management System (QMS). Audits are one of the most powerful tools that management has to assure on effective QMS.Price:$1400.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link
  • 17 Request Info

    Webinar On Test Method Validation to Verify your Device Performance

    This webinar will help you have an understanding of Test Method Validations to verify the performance of a Medical Device, global reference standards, the FDA requirements and how to perform successful TMV to ensure your inspection of verification is effective, using detailed real-life case studies.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/TEST-METHOD-MEDICAL-DEVICE-508490/MAY-2017-ES-TRAININGREGISTRY
  • 18 Request Info

    Webinar On Hypothesis Testing for Means - A Practical Approach

    One common statistical technique, especially useful in manufacturing is the hypothesis test. While it is common, it is not always well understood. In addition, some instances can involve complicated calculations. Hypothesis testing is a statistical procedure that helps determine if a set of data, typically from a sample, is compatible with a given hypothesis. This presentation focuses on hypothesis tests involving the means of a distribution, one of the most common applications.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/HYPOTHESIS-TESTING-503403/MAY-2017-ES-TRAININGREGISTRY
  • 19 Request Info

    Webinar On Understanding the Quality Indicator Survey Process (QIS), Quality Indicator Programs (QIP) and the processes and requirements of CMS for Fo

    Based on a 2010 survey 40 percent of the 15,000 long term care facilities failed to meet the bases of 42 CFR. This Webinar will focus on the opportunity for Food Service Operations to perform within the intended regulation, understand and interpret intent. This webinar may be used as a training tool for food service managers who want to perform higher in the (QIS), or who have failed in the past to implement CMS guidelines.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/QIS-QIR-CMS-FOOD-SERVICE-HEALTHCARE-502170/MAY-2017-ES-TRAININGREGISTRY
  • 20 Request Info

    Webinar On Cleaning Validations Using Extraction Techniques

    Cleaning validations are an essential step in the medical device development process. One of the most common methods is using extraction techniques to validate the cleanliness of a device. This webinar will provide valuable guidance on how to achieve a thorough validation of a cleaning process. These cleaning processes may include initial cleaning validations, in process cleaning validations, or reprocess cleaning validations.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/webinar/CLEANING-VALIDATIONS-EXTRACTION-TECHNIQUES-503258/JUNE-2017-ES-TRAININGREGISTRY