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Courses

  • 1 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
  • 2 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
  • 3 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
  • 4 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
  • 5 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
  • 6 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
  • 7 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
  • 8 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
  • 9 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
  • 10 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
  • 11 Request Info

    Medical Device Software Risk Management Standard | Software Expert 2018

    Engineers are dedicated to making things work, so a focus on how they might fail and harm someone can seem alien. Managing risk, however, is essential for all medical products- medical devices, including those involving software, have produced some painful examples of poor risk management with serious consequences. Experience has shown that there is a better way, that it is possible to manage risk in a changing business and technical world. Regulatory bodies are placing increased emphasis on risk management, and technology shifts are introducing new sources of risk. Newer Lean-Agile methods are recognized by the FDA as a good way to accomplish risk management. Techniques for risk management are well established, but require specific interpretation when applied to software. keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901345SEMINAR?trainingregistry-January-2018-SEO
  • 12 Request Info

    What is Project Management in Pharmaceutical Industry Seminar

    Project management is a discipline that can be applied to all industries. In the pharmaceutical industry, project management is the key to addressing the unique regulatory, compliance and quality related needs of the industry. The process of clinical research and drug development, coupled with the critical issue of time to market, can use project management techniques to effectively apply scheduling, risk management, and comprehensive quality assurance and control to the process of bringing a drug to market in a safe, effective & cost-efficient way Every industry has different "stress points"-those points that are most critical to the specific product or service being delivered. The most typical stress points are schedule, cost, and quality. Depending on the project keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901435SEMINAR?trainingregistry-January-2018-SEO
  • 13 Request Info

    What is Process Validation Report | 21CFR11 Compliance Checklist 2018

    Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901447SEMINAR?trainingregistry-January-2018-SEO
  • 14 Request Info

    Pharmaceutical Validation Guidelines | 21 CFR Part 11 Compliance 2018

    Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901444SEMINAR?trainingregistry-January-2018-SEO
  • 15 Request Info

    Enhancing Employee Engagement: Beating Burnout

    Persons who are responsible for the wellness of other persons and systems, such as care providers, managers, customer service staff and administrative professionals, often face stress and burnout resulting in absenteeism, turnover, increased errors and even mortality. This can be very harmful to organizational productivity and credibility, creating costly gaps in care and services. But who cares for the care providers and other employees? Providers and professionals working in education, healthcare, sales and hospitality must be reminded how to assert themselves, set healthy boundaries and respond to stress in healthy ways. Focus groups held by HCEI across the US confirm the need to celebrate the spirit and journey of caring persons while teaching self-preservation skills for the future. When employees care for themselves first they then provide better care and services to others.
  • 16 Request Info

    Beating Burnout in 2018!

    Persons who are responsible for the wellness of other persons and systems, such as care providers, managers, customer service staff and administrative professionals, often face stress and burnout resulting in absenteeism, turnover, increased errors and even mortality. This can be very harmful to organizational productivity and credibility, creating costly gaps in care and services. But who cares for the care providers and other employees? Providers and professionals working in education, healthcare, sales and hospitality must be reminded how to assert themselves, set healthy boundaries and respond to stress in healthy ways. Focus groups held by HCEI across the US confirm the need to celebrate the spirit and journey of caring persons while teaching self-preservation skills for the future. When employees care for themselves first they then provide better care and services to others.
  • 17 Request Info

    2018 Train-the-Trainer Course In Atlanta, GA

    Join TrainSMART in 2018 for our 3-day Train-the-Trainer Course in Atlanta, GA. If you are now accountable for any kind of training in your organization this class is for you! Learn the essential skills to transfer knowledge to adult learners in a way that is educational, interesting and interactive! Participants will learn: - the essential skills to teaching adult learners - how to design and develop training that “sticks,” - how to create a learning environment that is conducive to learning and fun. - Skills that will increase your confidence and credibility. - How to plan, develop and create training for virtual delivery. Become An Awesome Trainer Today!
  • 18 Request Info

    2018 Train-the-Trainer Course In Nashville, TN

    Join TrainSMART in 2018 for our 3-day Train-the-Trainer Course For New & Experienced Trainers in Nashville, TN. If you are now accountable for any kind of training in your organization this class is for you! Learn the essential skills to transfer knowledge to adult learners in a way that is educational, interesting and interactive! Participants will learn: - the essential skills to teaching adult learners - how to design and develop training that “sticks,” - how to create a learning environment that is conducive to learning and fun. - Skills that will increase your confidence and credibility. - How to plan, develop and create training for virtual delivery. Become An Awesome Trainer Today!
  • 19 Request Info

    2018 Train-the-Trainer Course In Irvine, CA

    Join TrainSMART in 2018 for our 3-day Master Training Program For The Learning Professional in Irvine, CA. If you are now accountable for any kind of training in your organization this class is for you! Learn the essential skills to transfer knowledge to adult learners in a way that is educational, interesting and interactive! Participants will learn: - the essential skills to teaching adult learners - how to design and develop training that “sticks,” - how to create a learning environment that is conducive to learning and fun. - Skills that will increase your confidence and credibility. - How to plan, develop and create training for virtual delivery. Become An Awesome Trainer Today!
  • 20 Request Info

    2018 Train-the-Trainer Course In Dallas, TX

    Join TrainSMART in 2018 for our 3-day Master Training Program For The Learning Professional in Dallas, TX. If you are now accountable for any kind of training in your organization this class is for you! Learn the essential skills to transfer knowledge to adult learners in a way that is educational, interesting and interactive! Participants will learn: - the essential skills to teaching adult learners - how to design and develop training that “sticks,” - how to create a learning environment that is conducive to learning and fun. - Skills that will increase your confidence and credibility. - How to plan, develop and create training for virtual delivery. Become An Awesome Trainer Today!