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Courses

  • 1 Request Info

    Aware of the Similarities and Differences in the files

    Overview: It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Why should you Attend: companies go global, they must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical File or Design Dossier.
  • 2 Request Info

    Products Used in Early Phase IND Studies

    Overview: How it may be integrated with the recommendations of the guidance documents on CMC requirements. Areas Covered in the Session: Discussion of the elements found in the guidance document for Phase 1 material What to do at really early stages What about special IND studies? What about preclinical studies?
  • 3 Request Info

    Clinical Data Systems Regulated by FDA

    Overview: Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction. Why should you Attend: You should attend this webinar if you are responsible for establishing or maintaining a TMF, or providing quality assurance for data included in the file. This webinar will also benefit those involved in the conduct of clinical trials, audit and inspection of clinical trial study data and records, and submission of filings to regulatory agencies that involve clinical trial data.
  • 4 Request Info

    The Value of a Human Factors Program

    Overview: This webinar will explain the implementation of ISO 62366 and the regulatory expectations discussed in the 2016 FDA Guidance for a compliant human factors/ usability program. Why should you Attend: This year FDA published their priority list for the completion of their Guidance documentation. This annual activity gives us inspection and enforcement insight into the priorities within the agency. Interoperability and Cybersecurity were in the top 3. The implementation of a robust HF program will include both of these disciplines.
  • 5 Request Info

    Ensuring Data Integrity and Safety in Clinical Research

    Overview: Electronic medical records and electronic handling of study data is increasingly common. To involve computer systems in clinical research implies knowledge of 21 CFR Part 11. Why should you Attend: The increasing use of computers and increasing complexity, all persons who have any data input requirements to know the set-up and function of the systems they are using. Forewarned is forearmed. Areas Covered in the Session: The CFR definitions of Electronic Record, Electronic Signature, Closed System, Open System, Data Trails, and assure that your data is secure and valid? What needs to happen to make data trails secure and real What questions should you internal QA department ask to be sure your system is functioning correctly? What controls need to be in operation for an open system? What are the controls needed for a valid electronic signature?
  • 6 Request Info

    Webinar onEffective Pharmaceutical GMP Audits and Self-Inspections

    Regulators expect audits and self-inspections of the manufacturer to assure the quality of its own operations and those of its suppliers and contractors via repeated audits. FDA and other regulators have contributed to and endorsed ICH Q10, Pharmaceutical Quality System, which explicitly recommends audits as a key element in the review of process performance and product quality and also in the management of outsourced activities and purchased materials.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/Effective-Pharmaceutical-GMP-Audits-and-Self-Inspections-507109/DECEMBER-2017-ES-TRAININGREGISTRY
  • 7 Request Info

    Webinar on Implementation of Risk Evaluation and Mitigation Strategy (REMS) - What do you need to do now?

    Attendees will receive knowledge on important and essential requirements related to Risk Management for potential pharmaceutical adverse effects. This webinar will provide basic understanding of requirements for REMS and steps to consider for implementation. 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/Implementation-of-Risk-Evaluation-and-Mitigation-Strategy-REMS-What-do-you-need-to-do-now-507343/DECEMBER-2017-ES-TRAININGREGISTRY
  • 8 Request Info

    Case Management's Role in Managing Third Party Payer Denials

    Case management, as a member of the revenue cycle team, plays a strategic role in the implementation of strategies aimed at reducing and/or preventing third party payer denials. Reducing and preventing denials requires proactive and hard-wired processes that engage the entire interdisciplinary care team. The causes of denials are complex and therefore require complex solutions. This program will review the causes of denials and key strategies for reducing and preventing them. Solutions will include key members of the interdisciplinary care team including physicians, physician advisors, case management leaders and case managers. Strategies for analyzing your denial rate will also be included. 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/Case-Management-s-Role-in-Managing-Third-Party-Payer-Denials-504198/DECEMBER-2017-ES-TRAININGREGISTRY
  • 9 Request Info

    Webinar on How to Consult to Physicians and Healthcare Leaders on Compliance Issues

    This presentation is designed to provide strategies and insights for effectively consulting to physicians and healthcare leaders on compliance issues. It will cover how to think and act like a consultant, deploying a consistent process for consulting, and strategies for communicating with disengaged physicians and leaders. Using a case scenario, this presentation will walk through the steps to consult internally on a hypothetical issue and offer insights for how to approach each step in the consulting process. 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/HOW-TO-CONSULT-TO-PHYSICIANS-AND-HEALTHCARE-LEADERS-ON-COMPLIANCE-ISSUES-502331/NOVEMBER-2017-ES-TRAININGREGISTRY
  • 10 Request Info

    Webinar on Veterinary Pharmacy Law and Occupational Safety Training in Veterinary Medicine

    The goal of this course is to help the learner to understand the laws that apply to filling prescriptions for animals, and to provide resources for finding answers to veterinary pharmacy situations. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://onlinecompliancepanel.com/webinar/VETERINARY-PHARMACYY-LAW-AND-OCCUPATIONAL-503173/NOVEMBER-2017-ES-TRAININGREGISTRY
  • 11 Request Info

    Applying ISO14971 and IEC62304 - A guide to practical Risk Management 2018

    Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management. keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901453SEMINAR?trainingregistry-January-2018-SEO
  • 12 Request Info

    Product Reliability Training Courses | Product Reliability Testing

    Although a primary objective of reliability analysis is to improve product reliability, there are many possible reasons for collecting and analyzing reliability data. Several examples are the following: Assessing product reliability in the field Predicting product warranty costs Estimate replacement part/spares requirements Assessing the effect of a proposed design change Demonstrating product reliability to customers or government agencies Comparing components from multiple suppliers Comparing components from different production periods, operating environments, or materials Improving reliability through the use of laboratory experiments keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901438SEMINAR?trainingregistry-January-2018-SEO
  • 13 Request Info

    Internal Audit Checklist for Medical Devices | Quality Audit

    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. In this workshop, participants examine the various types of audits to understand their role. Internal quality audits (1st party) help a company evaluate itself. Customer/supplier audits (2nd party) play a role in an effective supplier management program; your company could be the subject of the audit. Independent audits (3rd party) can help provide assurance about the health of a QMS. keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901429SEMINAR?trainingregistry-January-2018-SEO
  • 14 Request Info

    21 CFR Part 11 Validation Checklist | Computer Systems Validation

    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. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901300SEMINAR?trainingregistry-January-2018-SEO
  • 15 Request Info

    Complaints and Recalls | Complaint Handling System in Boston 2018

    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! This session will include the requirements for all of the above responsibilities, which will include defining, documenting, and implementing a complaint-handling system keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901339SEMINAR?trainingregistry-January-2018-SEO
  • 16 Request Info

    Verification vs. Validation - Product Process Software and QMS 2018

    This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management. This course will evaluate different field-tested, U.S. FDA-reviewed V&V protocols; how to employ equipment/process Requirements Specs / DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, all against a background of limited company resources. keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901450SEMINAR?trainingregistry-January-2018-SEO
  • 17 Request Info

    What is the HIPAA Compliance | HIPAA Privacy Compliance Training 2018

    This two day seminar takes the participants through HIPAA compliance from start to compliance. The first presentation explains the history of HIPAA, why it came to being and its evolution. This covers what HIPAA is, what steps have to be performed to be HIPAA compliant and what HIPAA compliance is. It also provides definitions to key HIPAA terms, how to define a Business Associate and how to contract with Business Associates. The second part of the first presentation is an overview of how to manage the HIPAA compliance project. At the end of these presentations there will be a workshop to demonstrate how to use these tools. keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901423SEMINAR?trainingregistry-January-2018-SEO
  • 18 Request Info

    FDA General Principles of Software Validation | Cyber Security 2018

    Software's level of complexity and use is expanding at exponential levels. Likewise, the potential risks to health follow suit. Ransomeware attacks hold your software hostage until you pay hundreds or thousands of dollars. Life supporting and life sustaining healthcare grinds to a halt. Extracting personal healthcare information is another plague that has a huge financial incentive for hackers. Your software is running on thin ice. The FDA looks at software in one of three ways: Standalone, such as for a mobile app; device-based software used to control a device's performance, or simply electronic records. FDA's risk classification will gradually clarify keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901393SEMINAR?trainingregistry-January-2018-SEO
  • 19 Request Info

    Principal Investigator Responsibilities in Clinical Research | GCP 2018

    This seminar is designed to acquaint all Participants with the Rules and Regulations that form the background of what is know as the GCP of Clinical Research. To follow "The Good Clinical Practices" (GCP) is to follow the standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trails that provides assurance that the data and reported results are credible and accurate and, most importantly, that the safety, rights, integrity, and confidentiality of trial subjects is protected. That all members of the team must know and practice "GCP" guarantees, that the Protocol is followed, that the Informed consent is complete, that the study conduct is according to the protocol, keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901351SEMINAR?trainingregistry-January-2018-SEO
  • 20 Request Info

    What is Computerized Testing Systems | GxP Compliance Testing 2018

    Testing is the science of identifying defects, so that they can be corrected, and of demonstrating that a system meets intended requirements. Testing computerized systems is considered a fundamental verification activity and appropriate testing is a regulatory expectation as described in many regulations e.g. EU GMP Annex 11. "Evidence of appropriate testing methods and test scenarios should be demonstrated. Particularly system (process) parameter limits, data limits and error handling should be considered" The regulated company is responsible for demonstrating compliance and fitness for use. Effective testing demonstrates compliance with regulatory requirements and ensures patient safety, product quality and data integrity as a result of controlling identified risks. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901363SEMINAR?trainingregistry-January-2018-SEO