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Courses

  • 1 Request Info

    The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems for Bio-pharma, Medical Devices and Cosm

    This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system. Without this understanding, water system control consists Click to Continue Reading: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901639SEMINAR?trainingregistry-April-2018-SEO
  • 2 Request Info

    A Risk Based Approach To Data Integrity 2018

    The impact of Data Integrity issues on a regulated company can be significant: it can result in recalls of products, warning or untitled letters, import alerts, injunctions, seizures, legal action, etc. These regulatory actions can have significant financial impact to the company. However, and most importantly, data integrity issues can lead to potential patient harm!! Defined by the Medicines and Healthcare Products Regulatory Agency (MHRA) as "the extent which all data are complete, consistent and accurate throughout the data lifecycle", data integrity is increasingly the focus of regulatory agencies round the world. Companies must now ensure that they are appropriately addressing data integrity and data governance. Click to Continue Reading: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901381SEMINAR?trainingregistry-April-2018-SEO
  • 3 Request Info

    Preparing the Marketing Authorization Application in the EU, with a focus on the product information

    In this seminar, we will look into all elements of the MAA dossier, in particular module 1, and within this module the Product Information. In addition, the various meetings with the Health Authorities in the centralized procedure will be discussed. Regular review and monitoring of product information for medicines is important, to support awareness of relevant updates/changes which may affect prescribing, dispensing, administration or monitoring practices. It is also important that patients and caregivers, as appropriate, are made aware of the information contained in the Package Leaflet (PL) and should be encouraged to read it prior to and during their treatment. Click to Continue Reading: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901315SEMINAR?trainingregistry-April-2018-SEO
  • 4 Request Info

    Implementing ISO 13485:2016

    The final version of ISO 13485:2016 is now available and companies should be planning their implementation. There are significant changes from the earlier version; they will require major modifications to the Quality Management System (QMS). The new version has better alignment with FDA's QSR, but there are still major differences that create issues for effective QMS implementation. This workshop covers the differences from the 2003 version to the 2016 version and offers practical implementation advice to update your QMS. Participants will also learn the differences with QSR and understand how to resolve them. The workshop uses extensive examples and exercises to help clarify the concerns. Click to Continue Reading: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901429SEMINAR?trainingregistry-April-2018-SEO
  • 5 Request Info

    Supplier Management in FDA- and ISO-regulated Industry 2018

    Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance. Many companies can spend significantly less time and money, and still be in control of their suppliers and in compliance with the regulations. This class will review the QSR and ISO requirements for supplier evaluation, including defining the types of suppliers that require evaluation. Click to Continue Reading: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901636SEMINAR?trainingregistry-April-2018-SEO
  • 6 Request Info

    Good Clinical Data Management Practices (GCDMP) 2018

    Good clinical data management (CDM) is paramount for a successful research. After all, Garbage In, Garbage Out (GIGO). CDM is involved in all aspects of collecting, processing, and interpreting information. There are many types of computer applications and database systems to support data collection and management. However, there are elements of Good Clinical Practice that apply across the board. Review and approval of drugs or devices by regulatory agencies requires the assumption that the data presented are valid and reliable. Integrity of the data is paramount to ensure confidence in the results and conclusions you will make. Click to Continue Reading: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901558SEMINAR?trainingregistry-April-2018-SEO
  • 7 Request Info

    The Value of a Human Factors Program 2018

    This seminar will explain the implementation of ISO 62366 and the regulatory expectations discussed in the 2016 FDA Guidance for a compliant human factors/ usability program. The ISO 62366 is an "Consensus" Standard, making it a gold standard for regulatory submissions. We will look at other reference points regarding HF, like AAMI/ANSI HE75:2009 and how HF Engineering include consideration of: Device Users Use Environments and User Interfaces Preliminary Analyses Exploratory HF/Usability Evaluations Hazard Mitigation and Control We will look at the implication of HFE through Design Controls in the QSR: Design input -includes "needs of the user and patient" Click to Continue Reading: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901504SEMINAR?trainingregistry-April-2018-SEO
  • 8 Request Info

    The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities

    This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together. Over time, there have been several misunderstandings between supplier / contractors and pharmaceutical / biologic finished product manufacturers. The root of many of the problems lie in a lack of a suitable agreement delineating roles, responsibilities and resolution to agreement to these issues. Part of these arrangements typically involve the development, support and updating of confidential technical files (Drug Master files), which allow suppliers to protect their confidential product and process information from each and every customer and share it only with the Agency. Click to Continue Reading: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901462SEMINAR?trainingregistry-April-2018-SEO
  • 9 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
  • 10 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
  • 11 Request Info

    eCTD Submissions of IND/NDA to the US FDA, EU and Canada

    The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times. Beginning in May 2017, the eCTD will be required in the US for all marketing applications. Click to Continue Reading: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901660SEMINAR?trainingregistry-April-2018-SEO
  • 12 Request Info

    A Risk Based Strategy for the Development & Validation of and Validation of Analytical Methods with a QbD Approach

    Following the initial development, the steps further continues thru optimization and subsequently to Validation, leading to the understanding of Validation Parameters and their generic definitions. Guidance from EP, USP, ICH Q2 (R)1, AOAC etc. will be discussed. The presentation continually builds on from a conceptual level to practical applications leading to data handling, Data Integrity, Validation Protocol and other documentation, vis-a-vis Regulatory requirements. Discussions provide extensive guidance for preparing Methods Validation Protocols for the various stages of regulatory submissions, e.g. IND, NDA, ANDA, PAI, CMC etc. Various aspects of Laboratory Controls (CGMP), QC procedures, SOPs that cover calibration, standardization, Qualification and Validation, will be included, along with statistical tools, SQC, SPC for processing and monitoring of analytical data. Strategies for the development Stability indicating assays will be touched along ...
  • 13 Request Info

    Evolution of the Quality Management System - How to go from Surviving to Thriving

    Many companies struggle to establish and maintain a Quality Management System (QMS) that is both efficient and effective. An ineffective QMS leads to disastrous consequences such as medical device reports, recalls, 483s, and warning letters. An ineffective QMS can result in serious consequences for your customers leading to dissatisfaction, serious injury, or even death. It is imperative that medical device companies can effectively establish a QMS. And an inefficient QMS results in wasted time, money, and missed opportunities. In this 2-day seminar, we will use lecture, exercises, and discuss to learn the fundamentals of a Quality Management System and how you can take your program from surviving to thriving. A thriving QMS can help you achieve your compliance objectives and improve product quality, leading to higher customer satisfaction and business results.
  • 14 Request Info

    HIPAA Training for the Compliance Officer 2018

    This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule and any other applicable updates for 2018 and beyond. There are an enormous amount of issues and risks for covered entities and business associates these days. I will speak on specific experiences from over 17 years of experience in working as an outsourced compliance auditor, expert witness on multiple HIPAA cases, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information. Click to Continue Reading: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901510SEMINAR?trainingregistry-April-2018-SEO
  • 15 Request Info

    Strategic Planning 101: How to Create, Draft, and Implement Your New Year Plan™

    The New Year will be upon us soon and it’s a time to start fresh. Leaders who lead their team best, put a powerful plan in place and incorporate what’s been done well and what is still to be done, ready to implement this plan before the first week of the year is done. Don’t get left behind or be left wondering what do we do now when January rolls around. Register for the upcoming Strategic Planning 101 webinar. In it, you’ll learn simple excises that engage the team in the plan creation, costly mistakes not to make, and immediate ways to progress on your goals faster than you think is possible. Bring your ideas to this course and even involve key team members so that when you end the call, you’ll be prepared to move fast!
  • 16 Request Info

    Strategic Leadership Skills for Human Resource Professionals™

    CEOs refer to those in Human Resources as the “brakes” on progress in an organization, while human resource professionals believe executives haphazardly always have their foot on the “accelerator”. In Strategic Leadership Skills for Human Resource Professionals™, those who oversee hiring, firing, recruiting, and talent management will learn ways to remove this misperception and reduce the gap in understanding. In fact, the skills in this course will significantly increase the perceived value of their role and actions. With five primary guidelines for thinking more strategically and a focus on emotional intelligence (and how to use it to be heard by executives), this webinar is designed with the HR professional in mind who wants to proactively claim a strategic seat at the table and finally be heard and well respected.
  • 17 Request Info

    iOS Training Course - 50% Hands On Labs

    articipants in this hands-on course will learn about and gain practice developing iOS applications for iPhone and iPad devices. Attendees will learn all the basics needed for iOS development, from installation of the Xcode editor to the Apple approval process. The Objective-C language is presented and used in hands on exercises to learn how it interacts with the hardware systems. Comprehensive hands on exercises are integrated throughout to reinforce learning and develop real competency. Students will create apps from the ground up, demonstrating the features of Objective-C and serving as an introduction to developing apps for release to the App Store.
  • 18 Request Info

    AWS Application Development Course

    This hands on course shows how to use the AWS (Amazon Web Services) SDK to develop secure and scalable cloud applications. The course provides in-depth knowledge about how to interact with AWS using code and includes coverage of architectural concepts, best practices, and troubleshooting tips. The course includes techniques for optimizing the use of the AWS Cloud by understanding AWS services and how these services fit into a cloud solution. Your architectural solution may differ depending on industry and size of business. Because there is no one-size-fits-all design, this course highlights some AWS Cloud design patterns to help you learn some of the common options for overall cloud design.
  • 19 Request Info

    jQuery Programming Course - 50% Hands On Labs

    This hands-on course covers the jQuery library, DOM manipulation, performing Ajax requests, and an overview of the UI library. Students will also learn how to use the jQuery function to return a wrapped set of elements, use utility functions to work with arrays and strings, modify the appearance of elements using a number of predefined effects as well as how to implement existing plugins. Comprehensive hands on exercises are integrated throughout to reinforce learning and develop real competency.
  • 20 Request Info

    How To Lead Angry Employees Through Major Change™

    Has something changed? Employees flipping out and mad as heck? Not everyone responds well to change and when employees get angry it slows down everyone’s work and acceptance of the new process even more! In How to Lead Angry Employees Through Major Change, you’ll learn how to lead employees who get angry because you changed their job, their title, their pay, or the company in which they work. With detailed steps for each scenario, this webinar will help you keep the peace, maintain your own sanity, and get everyone through the change so all can get back to work. A simple or major change doesn’t have to create major problems or shut down the office or the leader. You have enough to do and this webinar will help you get through…all of it. With a close look at how we all are wired to resist change, steps to overcome that natural reaction, and four easy to follow steps, this webinar is your go to source for dealing with change in the workplace.