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Courses

  • 1 Request Info

    Webinar on How to Navigate the Social Dynamics of Your Organization

    Learn the tools, methods and exercises you can use to navigate Social Dynamics to make work life more stress free and enjoyable. 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-Navigate-the-Social-Dynamics-of-Your-Organization-508486/APRIL-2019-ES-TRAININGREGISTRY
  • 2 Request Info

    You can do a Lot More than you Think

    This course offers practical approaches for supervision on the floor, strategies to get your group in sync and approach issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues, Also we will discuss why supervision is so important in reducing and preventing human error, And also you will learn how to measure human error rates at your department and keep track of metrics.
  • 3 Request Info

    European Data Protection Regulation - 2018 Implementation

    Overview: On 4 May 2016, the official texts of the Regulation and the Directive have been published in the EU Official Journal in all the official languages. While the Regulation will enter into force on 24 May 2016, it shall apply from 25 May 2018. The Directive enters into force on 5 May 2016 and EU Member States have to transpose it into their national law by 6 May 2018.
  • 4 Request Info

    Software and Device Changes and the 510(k)

    The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required. Examples of device changes and recommendations for documenting a company's decisions are provided. FDA provides a series of flowcharts and questions that can serve to guide medical device manufacturers to come to a conclusion as to whether a new 501(k) is necessary.
  • 5 Request Info

    Tougher Import Rules for FDA Imports in 2018

    FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import and export program find their shipments delayed, detained or refused. As of December 2016, FDA and CBP officially implemented the Automated Commercial Environment (ACE) entry filing system. You either meet ACE requirements or face entry refusals and monetary penalties of up to $10,000 per offense. Click to Continue Reading: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901402SEMINAR?trainingregistry-April-2018-SEO
  • 6 Request Info

    Complete 1099, TIN Matching, B-Notice, 1042-S Non-resident Alien and FATCA Compliance Update

    For years the IRS has struggled with the independent contractor, the non-resident alien worker, US citizens with foreign financial accounts and tax collection. They have placed the burden on businesses, non-profits and not-for-profits as well as state and local government to report information about taxable payments they make to their account holders, vendors and customers. In assessing opportunities to close the tax gap (taxes due but not reported or paid), one of the greatest opportunities comes from expanding information reporting on taxpayers by payers - the 1099 and the 1042-S. These time consuming reporting obligations can be streamlined in a number of ways. Click to Continue Reading: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901531SEMINAR?trainingregistry-April-2018-SEO
  • 7 Request Info

    21 CFR Part 11 Compliance Checklist- FDA Software Validation

    This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers. The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901525SEMINAR?trainingregistry-March-2018-SEO
  • 8 Request Info

    Regulatory Requirements Cleaning Validation | FDA Guidelines 2018

    This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901285SEMINAR?trainingregistry-March-2018-SEO
  • 9 Request Info

    Risk Management Education Course | Medical Devices Industry 2018

    Gaps, incorrect or incomplete implementation of software 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 device software in a regulatory compliant environment. Software risk management has to be embedded into the bigger scope of overall risk management. Therefore this course will additionally address the system level risk management and the resulting interfaces to software. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901459SEMINAR?trainingregistry-February-2018-SEO
  • 10 Request Info

    Why Measure Drug Plasma Levels | Drug Dissolution Testing 2018

    Drug dissolution testing is an essential and critical step for appropriate and efficient product development such as tablet and capsule. A number of approaches are used to conduct dissolution testing using different apparatuses and methods. Making a choice for an appropriate apparatus and method has always been confusing and challenging. This seminar will provide relevant pharmacokinetics and physiological background so that making this choice becomes easier and instinctive. No prior knowledge of pharmacokinetic and/or physiology is required; however, these will be explained in very simple terms to help attendees in selecting or developing a dissolution method. This seminar will describe in detail the theoretical aspect of the drug dissolution testing including method development. Pros and cons of different approaches will be explained in detail. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901498SEMINAR?trainingregistry-February-2018-SEO
  • 11 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.
  • 12 Request Info

    Why you Should be Worried about HIPAA 2017

    This seminar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits or (even worse) litigation occurs against your organization under state laws of negligence. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT. The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information all over regarding the do's and don'ts with HIPAA - I want to add clarity for compliance officers Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901048SEMINAR?trainingregistry-December-2017-SEO
  • 13 Request Info

    Celebrating Ourselves: Beating Burnout

    Who cares for the care provider? Both paid and non-paid persons who offer their compassion, skills and resources to those in need are often at risk for burnout, compassion fatigue or vicarious traumatization, creating costly health and emotional challenges and also gaps in expertise and caring. Care providers 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 caring persons care for themselves they provide better care for others. Seminar participants will be able to: Understand dynamics of providing care Articulate how each person experiences stress uniquely Identify symptoms of compassion fatigue Utilize practical, proven solutions and exercises for stress reduction Set healthy goals and create a future response plan for stress.
  • 14 Request Info

    FDA Scrutiny of Promotion and Advertising Practices 2017

    If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are loathe to even consult with each other. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901102SEMINAR?trainingregistry-November-2017-SEO
  • 15 Request Info

    Compliance Boot Camp 2017

    This 2-day seminar will cover the essentials of compliance for medical device companies. An efficient and effective quality system can be a competitive advantage for companies by leading to improved quality and compliance as well as optimizing the cost of quality. This "Compliance Boot Camp" will get you started in setting up just such a Quality System. We'll discuss the "case for quality" and how you can use compliance, not as an end itself, but as a means to improved quality and reduced cost of non-compliance. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901152SEMINAR?trainingregistry-November-2017-SEO
  • 16 Request Info

    GMP and Regulatory Expectations for Early IND Products 2017

    This course will present, in one place, the regulations and guidelines that apply to early phase products. In some cases these will not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. The course will present these items in the order of product development from the point of R & D activities to the completion of Phase 2 clinical trials. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901321SEMINAR?trainingregistry-November-2017-SEO
  • 17 Request Info

    Supplier Management for Medical Device Manufacturers 2017

    Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901162SEMINAR?trainingregistry-November-2017-SEO
  • 18 Request Info

    21 CFR Part 11 Compliance for Computer Systems Regulated by FDA 2017

    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. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901297SEMINAR?trainingregistry-November-2017-SEO
  • 19 Request Info

    Project Management for Non-Project Managers

    This two-day seminar will begin by laying the foundation for the subject by first defining what a project is and then discussing the unique roles that the project manager must assume along the length of any project. The Triple Constraint, the most fundamental of project management principles, will be explained in detail with examples and tools provided that can be used to integrate the principle into any project management process. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900998SEMINAR?trainingregistry-November-2017-SEO
  • 20 Request Info

    GMP and Regulatory Expectations for Early IND Products 2017

    This course will present, in one place, the regulations and guidelines that apply to early phase products. In some cases these will not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. The course will present these items in the order of product development from the point of R & D activities to the completion of Phase 2 clinical trials. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901318SEMINAR?trainingregistry-November-2017-SEO