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Courses

  • 1 Request Info

    New EU Medical Device Regulation | Updated Regulation 2018

    In 2012, the Commission adopted a package of measures on innovation in health. The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices. In particular, the Directives on active implantable medical devices (90/385/EEC) and on medical devices (93/42/EEC) are intended to be replaced by a Regulation on medical devices, while the Directive on in-vitro diagnostic medical devices (98/79/EC) is intended to be replaced by a Regulation on the same subject. The revisions therefore affected all kinds of medical devices including in vitro diagnostic medical devices, from home-use items like sticking plasters, pregnancy tests and contact lenses, to X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.
  • 2 Request Info

    FDA Trends for CSV Compliance and Enforcement | Boston Seminar 2018

    FDA requires that all computer systems used to produce, manage and report on "GxP" (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This seminar will help you understand the FDA's current thinking on computer systems that are validated and subject to inspection and audit. As a "GxP" system following Good Manufacturing, Laboratory and Clinical Practices; the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA's CFR Part 11 guidance on ER/ES must be followed.
  • 3 Request Info

    Biostatistics for Non-Statistician Salt Lake City Seminar 2018

    Statistics is a useful decision-making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand the theory and application of statistics. Many statistical software’s are now available to professionals. However, these software’s were developed for statisticians and can often be daunting to non-statisticians. How do you know if you are pressing the right key, let alone performing the best test?
  • 4 Request Info

    How to Register and Maintain Various Types of Combination Products | Seminar 2018

    A thorough understanding of the complexities involved Covers all the relevant regulations and guidelines Gives real life examples of how to register and maintain various types of combination products Interfaces: Change Management and LCM
  • 5 Request Info

    Writing & Managing Effective SOPs Seminar 2018

    Every biopharmaceutical company has SOPs, and new staff members are told that the company "has to have them" and that each employee "has to follow them". But why do there have to be SOPs and why must we follow them as written? And how can we do this effectively? Most people naturally want to do a good job. Successful managers recognize this fact and seek to channel workers' efforts in ways that will benefit the business. Well-written standard operating procedures (SOPs) provide direction, improve communication, reduce training time, and improve work consistency.
  • 6 Request Info

    Preparation of FDA Submissions and Communicating with the FDA | Seminar 2018

    What do the regulations say? Navigate the FDA drug and device approval system Prepare, construct and submit well-written IND, NDA, BLA, PMA, 510(k) and IDE submissions and regulatory filings Navigate the FDA review process Identify the required regulations and guidance documents for drug and biologic submissions Use regulations and guidance documents to outline and construct a variety of drug and biologic submissions Formulate a working knowledge of regulatory submissions, publishing, and style guides
  • 7 Request Info

    21 CFR Part 11 compliance for software validation and SaaS/Cloud Seminar 2018

    • Finally, the instructor reviews recent FDA inspection trends and discusses how to streamline document authoring, revision, review, and approval. • This course benefits anyone that uses computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications.
  • 8 Request Info

    Project Management Overview for Auditors Seminar 2018

    This class will explain what Project Management is and provide tools for understanding, and participating in, a Project. We'll cover how to write a clear and concise project statement, the basic phases of Project Management, and how to set up the project with measurable outcomes. We work through an example together that highlights how to set up the schedule, break a project down to manageable tasks, and talk about the reality of working on a Project while maintaining existing/ongoing workloads. We'll also discuss tools to track your Project, ways to minimize risk associated with the Project, and review a glossary of Project Management terms.
  • 9 Request Info

    Applying ISO14971 and IEC62304 | Risk Management Seminar 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.
  • 10 Request Info

    SOP Development and Implementation for the FDA-Regulated Industry 2018

    One of the best ways to ensure that an organization meets its regulatory obligations is to follow SOPs. SOPs are standardized procedures and processes prepared with enough detail to ensure that tasks are performed consistently each time they are done. SOPs are also required to be in compliance with regulations and guidelines internationally, across all regulated functions. Lack of SOPs and not following SOPs are often cited in regulatory inspections as deficiencies that must be corrected. Poorly prepared SOPs or poor compliance with existing SOPs can compromise a drug development program, an effective quality system, and may result in product recalls.
  • 11 Request Info

    Project Management for Non-Project Managers | Seminar 2018

    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.
  • 12 Request Info

    A Risk Based Approach to IT Infrastructure & Cloud Qualification 2018

    GxP Regulated companies are dependent on validated GxP computerized applications to conduct their day to day operations. These applications are, in turn, depended upon a qualified infrastructure that can be relied upon to provide control and regulatory compliance. The consequences of the IT Infrastructure being out of compliance can result in the failure of an entire site or geographic region being brought to a standstill while the compliance issue is resolved. It can also result in regulatory citations during a regulatory inspection as both the infrastructure be out of compliance and also cause the computerized applications that are dependent on it to be out of compliance.
  • 13 Request Info

    Complaint and Recall Management Seminar 2018

    This session will include the requirements for all of the above responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "non-complaint" feedback. Attention will be paid to the application of risk management to a complaint handling system, and a specific risk management system explained.
  • 14 Request Info

    Quality Management System Seminar 2018 | How to go from Surviving to Thriving

    Using lecture, discussion, and exercises, this 2 day seminar will focus on taking your QMS from surviving to thriving. We'll move from understanding the regulatory requirements, how to create your QMS structure, process thinking, and developing your improvement strategy. We'll discuss tools and techniques for improvement and how to measure your progress.
  • 15 Request Info

    HIPAA compliance from Start to Compliance 2018

    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.
  • 16 Request Info

    How to apply statistics to manage risks and validate processes in 2018

    The 2-day seminar explains how to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows: ISO standards and FDA/MDD regulations regarding the use of statistics. Basic vocabulary and concepts, including distributions such as binomial, hypergeometric, and Normal, and transformations into Normality. Statistical Process Control
  • 17 Request Info

    Medical Device Software: Approach to Risk and Quality Management 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.
  • 18 Request Info

    Managing Your FDA Inspection: 2018 Seminar

    FDA's inspection program follows well-established procedures and conducts the inspections with as much consistency as possible. FDA trains its investigators from day one. During the first six months, they attend extensive classroom and hands on training. FDA investigators learn basic skills. As time goes on, special training is given and the field staff use detailed reference materials to guide their thinking, actions, decisions and conclusions.
  • 19 Request Info

    What You Need to Do to Prepare for a Successful Inspection?

    Senior management takes responsibility for quality and GXP compliance. It is not something delegated to the quality unit or to the regulatory affairs group. Developing and implementing an effective inspection readiness plan will help ensure better results, as well as a less stressful Inspection. Planning strategically ahead will reduce document turn-around time, improve presentation skills from SMEs and increase inspector confidence in the quality system.
  • 20 Request Info

    Troubleshooting of Pharmaceutical Water Systems | Washington Seminar

    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.