Quality & Reliability

This training program will examine how human factors/usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA guidance document.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/Human-Factors-Usability-Studies-Following-ISO-62366-and-FDA-Guidance-504868/JANUARY-2018-ES-TRAININGREGISTRY

The revised Good Clinical Practice (GCP) guideline from the International Conference on Harmonization (ICH), known as ICH-GCP E6 (R2), has now been approved. This first update in two decades is expected to be adopted worldwide by regulatory agencies, including the FDA, EMA and Japanese Health Authority, and so brings major implications for all clinical development stakeholders. 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/ICH-GCP-E6-R2-Training-for-Investigators-and-Site-Personnel-508109/JANUARY-2018-ES-TRAININGREGISTRY

This webinar will demonstrate how biopharmaceutics may be used in the rational design of a drug product to achieve a desired therapeutic objective. Furthermore, the webinar will discuss the measurement of drug product performance, in vitro, including drug dissolution and in vitro in vivo correlation. 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/Biopharmaceutic-Considerations-in-Drug-Product-Design-and-In-Vitro-Drug-Product-Performance-502689/JANUARY-2018-ES-TRAININGREGISTRY

In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system. 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/FDA-Regulations-for-Analytical-Instrument-Qualification-and-Validation-Processes-504473/JANUARY-2018-ES-TRAININGREGISTRY

Kano Analysis, an important tool for product development, uses a structured methodology to help determine important device characteristics. For example, if customers expect a device will have a certain feature, they would be disappointed if it isn't there. However, if it were there, it doesn't create satisfaction; it was assumed.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/Kano-Analysis-for-Product-Decisions-508099/JANUARY-2018-ES-TRAININGREGISTRY

Regulators frequently cite concerns with environmental monitoring and the lack of a well-thought out rationale. This shortfall can be overcome through the application of risk assessment and scientific approaches. The application of risk assessment applies to selecting location for monitoring and frequencies of monitoring; and for data assessment. This presentation outlines the primary tools that can be used to achieve this.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/Risk-Based-Approach-to-Environmental-Monitoring-504486/DECEMBER-2017-ES-TRAININGREGISTRY

Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quality Engineering may need to trend the complaints!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/COMPLAINT-MANAGEMENT-502650/AUGUST-2017-ES-TRAININGREGISTRY

This webinar will discuss the FDA requirements for design, validation and monitoring of pharmaceutical water systems. There are many different types of pharmaceutical waters and each must be fit for its intended use. Pharma water must be controlled for impurities. Pharma water systems must be designed, validated and monitored to ensure that the water produced meets specifications around the clock.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/PHARMACEUTICAL-WATER-SYSTEMS-509631/JULY-2017-ES-TRAININGREGISTRY

Product Reliability requirements must be satisfied like all other performance requirements prior to product launch. However, since reliability is a function of time, the methods for verifying that reliability performance has been verified differ than for most other performance characteristics. This webinar will present several approaches for verifying that reliability targets or specifications have been achieved at the desired level of confidence. Specifically, approaches using time-to-failure data to estimate reliability metrics as well as demonstration tests, where minimum reliability may be demonstrated with zero or few failures are discussed.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/DEMONSTRATING-PRODUCT-RELIABILITY-508137/JULY-2017-ES-TRAININGREGISTRY

This webinar will cover the basics on how to maintain a good Design History File (DHF) that will help a manufacturer in a regulatory compliance audit. The webinar will cover the structure of a DHF and steps to ensure that the DHF is completed as the design and development process progresses. The DHF needs to be maintained as design changes are performed. Information in the DHF can help facilitate design decisions, which often can affect the safety of the device. The DHF provides the knowledge base needed for the manufacturer to maintain the device. It also provides the secrets to a successful Design Control audit.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/GOOD-DESIGN-HISTORY-FILE-AUDIT-506688/JULY-2017-ES-TRAININGREGISTRY

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

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

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.

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

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

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.

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.

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

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

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