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  • 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

    Acceptance Sampling Plans for Process Validation and Production Lot Monitoring

    Overview: Personnel involved in process validation and production control often rely on sampling methods to determine the suitability of a process before moving to production (process validation) or for checking production lots for acceptance. This webinar provides details regarding the generation of sampling plans that meet the desired statistical properties. By attending this webinar, participants will be able understand the key inputs and issues involved in determining acceptance sampling plans. Although software is generally used to generate sampling plans, the participants will gain useful insight into the methodology and its use in typical applications.
  • 3 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.
  • 4 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
  • 5 Request Info

    Webinar on CFPB Compliance- Mortgage Audit

    Sign Up for this new webcast and find out how to be prepared for the CFPB examination or audit and get practical advice for responding to the CFPB. Price:$199.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/CFPB-Audits-Being-Prepared-and-Staying-Compliant-to-Save-Time-and-Money-506956/NOVEMBER-2019-ES-TRAININGREGISTRY
  • 6 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.
  • 7 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.
  • 8 Request Info

    6-Hour Virtual Seminar on Transition from Peer to Supervisor

    Today's workforce is experiencing high turnover and disengaged employees. It is a known fact that employees quit managers- to avoid turnover it is critical to have the appropriate skills to retain employees. Transition from a Peer to Supervisor can be very difficult for most newly promoted supervisors. Many are not equip with the tools to successfully transition. This seminar will equip newly promoted supervisor with tools and techniques to decrease turnover, increase employee engagement and increase employee productivity.
  • 9 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.
  • 10 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
  • 11 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.
  • 12 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.
  • 13 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
  • 14 Request Info

    Centrifugal Pump Hydraulics, Sizing And Design Practices

    This one-day course is for technical personnel involved in the sizing, selection and operation of Pumps in Oil and Gas Processing facilities. The course focuses on the hydraulic principles of centrifugal pumps, their sizing and system design. You will learn quick pump calculations for conceptual studies along with rules of thumb as well as rigorous calculation required during detailed engineering phase. This course is tailored for individuals who have some pump basic knowledge and/or are seeking a deeper understanding of how centrifugal pumps work, and when and how to apply this knowledge. This course benefits those who are involved in some facet of pump design or application. Technicians, Operators and Junior Engineers will find this course especially helpful and relevant.
  • 15 Request Info

    Overpressure Protection Training

    This one day course will cover three principal aspects of overpressure protection. Firstly the regulatory requirements that must be met in Alberta. Secondly the many ways in which overpressure can occur. Thirdly the ways to mitigate against overpressure. Topics such as relief scenarios, ABSA, ASME, double contingency together with an in depth review of relief device types and sizing will be covered. Examples of relief scenarios and calculations to size relief devices will be included. This course will benefit designers of facilities, operators of these facilities and process safety personnel.
  • 16 Request Info

    echnical Safety BC From Design to Operation

    The purpose of this seminar is to increase the skill and knowledge of Engineers, managers and operators in Technical Safety BC, and Safety Code requirements in British Columbia Oil and Gas industries. Seminar Objectives The overall objective of this seminar is to give students a background in: 1. Technical Safety BC requirement for Design, Fabrication, Construction, Welding, Inspection, In-service Inspection of Pressure Equipment. 2. Interfaces between Technical Safety BC and OGC (British Columbia Oil and Gas Commission)
  • 17 Request Info

    ABSA Requirements From Design to Operation

    The purpose of this seminar is to increase the skill and knowledge of Engineers, Managers and Operators in ABSA (Alberta Boilers Safety Association), and Safety Code requirements in Alberta Oil and Gas industries. Seminar Objectives The overall objective of this seminar is to give students a background in: 1. ABSA requirements for Design, Fabrication, Construction, Welding, Inspection, In-service Inspection of Pressure Equipment. 2. Interfaces between ABSA and AER (Alberta Energy Regulator) A complete set of course materials is included in the ABSA Requirements From Design to Operation course.
  • 18 Request Info

    Quantifying Risk and Making Decisions Without Bias

    This highly interactive one-day course is designed for leaders, team members, and anyone who needs to assess risk and make decisions. Too often these two activities are based on subjective bias and not objective facts. This course will discuss the bias that we all have and present methods to assess risk and make decisions as a team with minimal bias to obtain the best possible results. The methods of facilitated risk assessment using risk matrices and fault tree analysis will be explained and both methods practiced in the classroom. A structured and quantified method of making decisions will be taught and practiced based on the Kepner Tregoe Method.
  • 19 Request Info

    A Second Life for SPC: From Control to Management

    In this presentation we will show how SPC can have a major impact on our businesses if we start using it as a managerial tool, Statistical Process Control (SPC) is one of the fundamental techniques in quality management, And This webinar will show you why and what you can do about it, The purpose is no longer to control a technical process but to manage your business processes in a much better way.
  • 20 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.