Industrial - Operations & Maintenance

For medical device manufacturers, human factors engineering has gradually become part of the standard expectations for products on an FDA approval pathway. Though it is possible to execute successful studies that only meet the FDA's minimum standards for human factors, this strategy does not necessarily result in products that have been optimized for safety and usability.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/MEDICAL-DEVICE-DEVELOPMENT-LIFECYCLE-505949/JULY-2017-ES-TRAININGREGISTRY

If statistical analysis is not properly performed and/or understood, a firm can run the risk of distributing the kind of product to the market that ultimately fails, resulting in lost time and money. Statistics of course, requires constant practice. This seminar will be highly interactive and participative. Participants apply their learning of statistics to real-world example data sets. The program begins by providing a basic overview of the most common statistical tools and terms. By the end of day two, course participants will have acquired the skills necessary to read and understand statistical reports contained in the CMC section including statistically sound sampling plan. One of the outstanding features of this learning session is that throughout its duration, it will allow complete interaction of the participants with both an expert instructor and their peers.

I will be speaking to real life audits conducted by the Federal government for Phase 2 and beyond (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). It seems almost daily I am receiving calls from nervous practice managers and compliance officers all over the USA regarding a HIPAA audit letter or call they have received. This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017.

This webinar will focus on the importance of retaining documents; the reasons supporting records retention; the importance of document retention; legal implications and dangers if a company fails to retain documents; formulating a leadership team to discuss which documents should be retained and how; and possible computer systems from which documents could be stored and retrieved.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/THE-ABCs-DOCUMENT-RETENTION-RETRIEVAL-502864/MAY-2017-ES-TRAININGREGISTRY

Documenting employee discussions is a very tricky and at times painful activity for organizations. While it is crucial for HR for a number of reasons, it is a difficult habit for the other employees to imbibe. Documenting employee discussions is important from a legal perspective, because this makes the case strong and defensible.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/DOCUMENT-EMPLOYEE-DISCUSSIONS-508343/APRIL-2017-ES-TRAININGREGISTRY

The secret is - HIPAA Rules are easy and routine to follow - when they are explained step-by-step in plain language. In this seminar Paul Hales will capture your attention with visual presentations, discussion and learning exercises and show how to find the right rule with the step-by-step procedures you need when you need them. Seminar Takeaways: Thorough Understanding of HIPAA Rules What they are How they work together Why and How they were made How they are changing and what to expect next HIPAA Risk Analysis - Risk Management for Your Organization A Practical Guided Exercise done in class on your computer to take home Privacy and Security Rules - Permitted and Required Uses and Disclosures

This course is designed to introduce to individuals the understanding and interpretation of the statistical concepts one uses when investigating quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits, and process and quality control. One also considers ICH Q8 and Q9. These techniques covers both clinical and laboratory applications. This applies to many areas such as stability testing, outlier analysis and risk management. It is not a course in statistics but introduces the participant to an applied approach to the statistical techniques one uses, how they are reasonably interpreted. One will address the various challenges facing pharmaceutical and biotechnology companies when it comes to quantifying results in a meaningful interpretable manner through tabulations and graphical presentations.

In this informative webinar, you'll learn what’s involved in transitioning to a supervisory position, including the basic components of every management position, the inherent challenges faced by newer supervisors, the many roles and task that supervisors must fulfill, and the traits that make someone a good candidate to succeed as a supervisor. In short, we’ll clarify what you can expect as a new manager and provide you with tips for success.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/STEPPING-UP-MANAGEMENT-501989/MARCH-2017-ES-TRAININGREGISTRY

This webinar will describe how to build a program for the preparation of a third party or regulatory audit. The webinar will describe what you should prepare for prior to an audit. This will include key programs such as sanitation, operations, pest control, preventative maintenance, allergens, HACCP and other key areas. The preparation will also include basic information on how both 3rd party and regulatory auditors conduct their inspections.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/FOOD-SAFETY-504029/MARCH-2017-ES-TRAININGREGISTRY

In this webinar, you will learn the required contents of Module 3 as well as the appropriate formatting. Lifecycle management and updating requirements will be discussed, including appropriate change control and sponsor notifications. You will also gain an understanding of contact points with the FDA throughout the lifecycle of the DMF, including information requests and inspections.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/DRUG-MASTER-FILES-DMFs-509436/FEBRUARY-2017-ES-TRAININGREGISTRY

This 21 CFR Part 11 training will analyze the regulations and provides concrete guidance on compliance for Electronic Medical Records.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/21-CFR-PART-11-ELECTRONIC-MEDICAL-RECORDS-502044/FEBRUARY-2017-ES-TRAININGREGISTRY

The global Internet of Things and the HIPAA Privacy and Security Rules allow Protected Health Information (PHI) created by Covered Entities in the United States to be transmitted and stored outside the United States - and outside the reach of U.S. government regulators. Risks for Covered Entities, patients and Business Associates may lurk anywhere in a world where identity theft is rampant and medical identity is the Golden Egg for identity thieves.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/OFF-SHORE-BUSINESS-ASSOCIATES-HIPAA-502042/FEBRUARY-2017-ES-TRAININGREGISTRY

The FDA has progressively increased requirements for human factors and usability testing before new medical devices can be approved for market release. However, successful market release does not ensure a device is easy to use or that all potential for safety-critical errors has been mitigated. Medical device purchasers must consider incorporating human factors as a standard part of the procurement process to ensure that they are choosing the safest, most usable devices for purchase.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/MEDICAL-DEVICE-PROCUREMENT-501983/DECEMBER-2016-ES-TRAININGREGISTRY

This webinar is intended to provide advice on the level of detail required for regulatory submissions at different program phases. Regulatory strategy across the development program will also 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://onlinecompliancepanel.com/webinar/CMC-REGULATORY-SUBMISSION-501931/DECEMBER-2016-ES-TRAININGREGISTRY

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

It is quite common between departments or individuals to neglect seeing the importance of 21 CFR Part 11 and Annex 11 (ERES) Compliance. Non-QA trained personnel or those that have no direct or have indirect contact with GxP systems fail to see the consequences of their actions or that of their department.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/21CFR-PART-11-ANNEX-11-COMPLIANCE-501871/NOVEMBER-2016-ES-TRAININGREGISTRY

$175,000 Per Day is the Cost of a Hazardous Material Shipping Violation-Know How to Avoid These Costly Mistakes in 60 minutes! Join this webinar to get insights into what to expect from a hazardous materials inspection and how to make the best of it. Be better prepared to minimize exposure to violations and avoid penalties that can exceed $175,000 per infraction per day.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/DOT-HAZARDOUS-ENFORCEMENT-501729/OCTOBER-2016-ES-TRAININGREGISTRY

Warning Letters from FDA frequently cite Acceptance Activities. In fact, it has been in the top five most frequently cited sections over the past few years. You can avoid a Warning Letter if you understand the regulations and develop processes to implement them. This presentation provides knowledge and tools to help implement an effective system that will withstand an FDA Inspection.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/ACCEPTANCE-ACTIVITIES-QSR-501690/OCTOBER-2016-ES-TRAININGREGISTRY

This webinar addresses the recently updated 1976 Toxic Substances Control Act (TSCA). Its new name is chemical safety in the 21st Century. The updated act is titled, "Frank R. Lautenberg Chemical Safety for the 21st Century Act." The act was named in honor of Senator Lautenberg because he was an ardent proponent of modifications to TSCA during his lifetime.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/CHEMICAL-SAFETY-21st-CENTURY-ACT-501753/OCTOBER-2016-ES-TRAININGREGISTRY

Production and Process Controls (P&PC;) are one of the key capabilities necessary for medical device companies to consistently and effectively produce products. P&PC; is critical to producing safe and effective products for your customers. It is a broad area covering environmental, personnel, contamination, building, equipment, inspection, materials, and more. Because of its criticality, P&PC; is one of areas most closely inspected by the FDA. This webinar will help you understand what is necessary for P&PC; and how to integrate it seamlessly with the rest of 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/PRODUCTION-PROCESS-CONTROL-MEDICAL-DEVICE-501676/OCTOBER-2016-ES-TRAININGREGISTRY