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Courses

  • 1 Request Info

    Risk Management in Medical Device Design

    Overview: The webinar will explore the basic principles of risk management and planning as they relate to medical device design and as required by the FDA. It will present a logical process for risk management from risk identification through evaluation/rating and mitigation. Why should you Attend: The secret to preventing medical device recalls or at least to minimizing their impact is sound Risk/Hazard Analysis. Aside from being required, it is absolutely essential and necessary to the development and fielding of medical devices that offer a significant level of protection for patients and manufacturers alike.
  • 2 Request Info

    FDA's New Import Program for 2020

    Overview: The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information.
  • 3 Request Info

    Webinar on Understand the Validation of Compressed Air Systems

    This course will discuss potential contamination types in pharmaceutical compressed air systems and how to prevent them. Price:$229.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/Validation-of-Pharmaceutical-Compressed-Gasses-504645/NOVEMBER-2019-ES-TRAININGREGISTRY
  • 4 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.
  • 5 Request Info

    Leadership and Team Development for Managerial Success

    Inspire and influence your team members to achieve your goals as a team! Managers who will be promoted are the ones who not only manage efficiently but also lead their teams effectively. Learn how to work in a horizontal mode of operation…apply a consistent theory in leading your team…and teach critical leadership skills to members of your team, so each and every one of them can lead the team in your absence.
  • 6 Request Info

    6-Hour Virtual Seminar on Clinical Data Management - Part II

    When new drugs or devices are tested in humans, the data generated by, and related to, these trials are known as clinical data. This data represents a huge investment by the biopharmaceutical or device company and is one of its greatest assets. It is this data that will eventually make a new product both useful as a treatment or therapy and marketable. The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. As its importance has grown, clinical data management (CDM) has changed from an essentially clerical task in the late 1970s and early 1980s to the highly computerized specialty it is today.
  • 7 Request Info

    Webinar on Combination Products - Identify and Navigate Regulations

    Attend this training to understand the definition of combination products and determine the required regulations from FDA. Price:$229.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/Understanding-Combination-Products-Navigating-the-Rules-and-Regulations-503612/SEPTEMBER-2019-ES-TRAININGREGISTRY
  • 8 Request Info

    FDA Requirements for Design Inputs and Outputs

    This webinar will walk you through step-by-step how to complete a DIOM for your product and simplify this often overly complex process, This webinar provides a simplistic tool to help identify and categorize design inputs, determine the most effective method in providing design output evidence, and showing traceability to all activities associated with both.
  • 9 Request Info

    AML High-Risk Transactions - Identify, Manage, Resolve

    Overview This webinar will discuss the techniques for controlling and managing High Risk Transaction. The Instructor will discuss the parameters for identifying and qualifying transactions as high risk and process and communication to be followed. He will also discuss how to resolve the end result.
  • 10 Request Info

    Effective Records Management & Document Control for Medical Devices

    Overview The document management system for medical device industry should help companies have control over critical activities such as: Establishing best practice SOP, Deviation, CAPA, Change Controls, Complaint and Audit processes Conducting Risk Assessment, Root Cause Analysis and Impact Assessment where appropriate Creating Action Plans, and verifying their effectiveness Improving efficiencies over the QMS tasks Reducing the risks of manual error Ensuring compliance to 21 CFR Part 11 and immutable audit trail Avoid observations, 483 letters and fines Taking the resource burden out of creating dashboards/ periodic reports
  • 11 Request Info

    Exploring the FDA Refuse-To-Accept (RTA) Guidance for 510(k) Submissions

    The FDA has instigated a Refuse to Accept Policy and will no longer accept 510K submissions that do not meet a minimum threshold of acceptability. By doing so, the Center for Devices and Radiological Health, will be able to focus substantive review on submissions that are complete. It is expected that 510(K)s that are accepted under this new policy, will be reviewed more quickly.
  • 12 Request Info

    Managing Complaints, Small Business Perspective

    This webinar will review GMP requirements for complaint handling. We will also discuss the types of complaints (adverse and non-adverse events) that may be received. You will learn about the key components in managing complaints such as tracking the complaint from time of receipt to completion, initiating and performing a complaint investigation, evaluating the complaint for medical device reporting, final review of the complaint and investigation and preparing a response to the complainant.
  • 13 Request Info

    The 7 Habits of Highly Effective Project Managers

    Overview: Too often Project Leaders and Managers fall into the role due to demonstrated technical competence. After all, if you're competent enough to create great technical output, certainly you can figure out how to run a project on schedule and within budget, right? And even when you get an opportunity to attend training to become a better Project Manager, the focus is on the "hard" or technical aspects of project management rather than the "soft" skills or habits that typically only come with experience.
  • 14 Request Info

    EU ISO 13485:2016 Medical Device Quality Management System

    This webinar will examine the changing focus of medical device regulation, similarities and differences between ISO 13485 and 21 CFR 820 (FDA's Device CGMPs), We will establish the correct definition of "risk", tied to ISO 14971 which has led to some major issues with companies selling to both the US and the EU.
  • 15 Request Info

    21 CFR Part 11 - Compliance for Electronic Records and Signatures

    This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained. FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient. FDA has set up regulations that address both data security and patient safety. We will show how 21 CFR part 11 considers both.
  • 16 Request Info

    Quality Management Systems for Medical Devices

    This webinar presents to the participants the new requirements of the standard and how they correlate with the regulatory changes in the EU. Prior to engaging the process of establishing and certifying a QMS for medical devices or enhancing the QMS to the newly introduced requirements, a review of those requirements and how to approach them is important.
  • 17 Request Info

    Risk Management in Medical Device Design

    Overview: The webinar will explore the basic principles of risk management and planning as they relate to medical device design and as required by the FDA. It will present a logical process for risk management from risk identification through evaluation/rating and mitigation. Why should you Attend: The secret to preventing medical device recalls or at least to minimizing their impact is sound Risk/Hazard Analysis. Aside from being required, it is absolutely essential and necessary to the development and fielding of medical devices that offer a significant level of protection for patients and manufacturers alike.
  • 18 Request Info

    Accelerated Aging Techniques for Medical Device Packaging

    Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods. AA is used to estimate the useful lifespan of a product or its shelf life when actual lifespan data is unavailable. The ability of product designers to accurately predict changes in polymer properties is of critical importance to the medical device, consumer, and industrial markets.
  • 19 Request Info

    Skills and Competencies Needed to Succeed in Today's Workplace

    What critical thinking means Why it's important How it relates to you in the workforce How better thinking skills can help you How you can learn to think critically to make decisions and set goals To examine the fundamentals of critical thinking, problem solving, decision making and goal setting To explore the relationship between critical thinking and career self assessment To help participants make informed and wise decisions To help participants approach problem solving and decisions making effectively
  • 20 Request Info

    Industry Best Practices for a Learning Culture

    The first is the ability to design the organization to match the intended or desired outcomes, and second, the ability to recognize when the initial direction of the organization is different from the desired outcome and follow the necessary steps to correct this mismatch. Organizations that are able to do this are exemplary.