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  • 1 Request Info

    Aware of the Similarities and Differences in the files

    Overview: It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Why should you Attend: companies go global, they must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical File or Design Dossier.
  • 2 Request Info

    How software requirements are used in validation

    Overview: This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing. Why should you Attend: Testing software to prove that it works and has no bugs is not sufficient to obtain FDA approval. There are additional requirements,analyses and tests that FDA feels are necessary to prevent user injuries.
  • 3 Request Info

    Products Used in Early Phase IND Studies

    Overview: How it may be integrated with the recommendations of the guidance documents on CMC requirements. Areas Covered in the Session: Discussion of the elements found in the guidance document for Phase 1 material What to do at really early stages What about special IND studies? What about preclinical studies?
  • 4 Request Info

    Excel - Benefits and Hazards in Office 365

    Overview: In this valuable presentation, Excel expert David Ringstrom, CPA, explains how the Office 365 version of Excel 2016 differs from previous versions and perpetual licensed versions of Excel 2016. Historically, each major version of Excel was identical for all users, but that's no longer the case. Why should you Attend: Apply pivot table-specific options in the Office 365 version of Excel 2016 to minimize repetitive work Learn keyboard shortcuts and tips that will help you work more efficiently in Excel
  • 5 Request Info

    Which data and systems are subject to Part 11

    Overview: This webinar details the regulation and how it applies to computerized systems. Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. Areas Covered in the Session: Which data and systems are subject to Part 11 What Part 11 means to you, not just what it says in the regulation Avoid 483 and Warning Letters Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation Ensure data integrity, security, and protect intellectual property
  • 6 Request Info

    To Facilitate a Closed-Loop Problem Resolution System

    Overview: Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations. Why should you Attend: Expectations for meaningful CAPA, supported by results-driven Failure Investigation and Root Cause Analysis, that addresses and resolves underlying product problems, are growing among regulatory agencies world-wide.
  • 7 Request Info

    Clinical Data Systems Regulated by FDA

    Overview: Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction. Why should you Attend: You should attend this webinar if you are responsible for establishing or maintaining a TMF, or providing quality assurance for data included in the file. This webinar will also benefit those involved in the conduct of clinical trials, audit and inspection of clinical trial study data and records, and submission of filings to regulatory agencies that involve clinical trial data.
  • 8 Request Info

    The Value of a Human Factors Program

    Overview: This webinar will explain the implementation of ISO 62366 and the regulatory expectations discussed in the 2016 FDA Guidance for a compliant human factors/ usability program. Why should you Attend: This year FDA published their priority list for the completion of their Guidance documentation. This annual activity gives us inspection and enforcement insight into the priorities within the agency. Interoperability and Cybersecurity were in the top 3. The implementation of a robust HF program will include both of these disciplines.
  • 9 Request Info

    Ensuring Data Integrity and Safety in Clinical Research

    Overview: Electronic medical records and electronic handling of study data is increasingly common. To involve computer systems in clinical research implies knowledge of 21 CFR Part 11. Why should you Attend: The increasing use of computers and increasing complexity, all persons who have any data input requirements to know the set-up and function of the systems they are using. Forewarned is forearmed. Areas Covered in the Session: The CFR definitions of Electronic Record, Electronic Signature, Closed System, Open System, Data Trails, and assure that your data is secure and valid? What needs to happen to make data trails secure and real What questions should you internal QA department ask to be sure your system is functioning correctly? What controls need to be in operation for an open system? What are the controls needed for a valid electronic signature?
  • 10 Request Info

    Act for Transportation and Logistics Professionals

    Overview: The FSMA is paradigm shift that moves the focus from food inspections to preventative measures and process compliance. Why should you Attend: Specific provisions of the FSMA that impacts transportation and 3rd party logistics providers Sanitary transportation best practices To develop a food safety plan that identifies potential risks, preventative controls and ongoing monitoring New rules that govern food importers and exporters Areas Covered in the Session: How the trend toward transparency and widespread supply chain knowledge (among consumers) will impact sourcing decisions Why sustainable supply chains will become more mainstream, especially among luxury buyers and millennials Why low cost country sourcing will be replaced by production closer to consumers
  • 11 Request Info

    Optimizing Process Behavior Using Design of Experiments

    Overview: This webinar will review the key concepts behind Design of Experiments. A strategy for utilizing sequential experiments to most efficiently understand and model a process is presented. Many common types of experiments and their applications are presented. Why should you Attend: Learn a methodology to perform experiments in an optimal fashion Review the common types of experimental designs and important techniques Develop predictive models to describe the effects that variables have on one or more responses Utilize predictive models to develop optimal solutions
  • 12 Request Info

    Webinar on Successfully Avoiding and Defending against Unemployment Claims

    This webinar presents tactics and strategies to help avoid losses from unemployment insurance claims. The attendee will learn how to plan for and respond to claims for unemployment insurance. From the design and implementation of policies that will defend your termination decision to attending and handling the hearing and beyond, this presentation will provide you the information you need to prepare for success. 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/Successfully-Avoiding-and-Defending-against-Unemployment-Claims-502440/DECEMBER-2017-ES-TRAININGREGISTRY
  • 13 Request Info

    Webinar on AML Investigations and SAR Preparation

    This training program will provide guidance in recognizing, investigating and reporting suspicious activities. It will also discuss instructions on implementing and maintaining an enterprise wide compliance program to safeguard the financial system from illicit use and combat money laundering and promote national security through the collection, analysis, and dissemination of financial intelligence to the regulatory authorities.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/AML-Investigations-and-SAR-Preparation-502122/DECEMBER-2017-ES-TRAININGREGISTRY
  • 14 Request Info

    Webinar on BSA Risk Assessment: Documenting BSA/AML Risks to Comply with Regulatory Expectations

    There has been an increase in regulatory scrutiny over how financial institutions document their BSA/AML risk controls in the risk assessment. Even though financial institutions have been documenting risk assessments over a long period of time, the expectations have moved from a generalist approach to a more meaningful and specific approach that truly outlines the specifics of the BSA/AML program. 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/BSA-Risk-Assessment-Documenting-BSA-AML-Risks-to-Comply-with-Regulatory-Expectations-509222/DECEMBER-2017-ES-TRAININGREGISTRY
  • 15 Request Info

    Webinar onEffective Pharmaceutical GMP Audits and Self-Inspections

    Regulators expect audits and self-inspections of the manufacturer to assure the quality of its own operations and those of its suppliers and contractors via repeated audits. FDA and other regulators have contributed to and endorsed ICH Q10, Pharmaceutical Quality System, which explicitly recommends audits as a key element in the review of process performance and product quality and also in the management of outsourced activities and purchased materials.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Effective-Pharmaceutical-GMP-Audits-and-Self-Inspections-507109/DECEMBER-2017-ES-TRAININGREGISTRY
  • 16 Request Info

    Medical Device Software: Verification, Validation & Compliance

    Software design is a complex set of interactions within the device, with the connecting devices, and with users of the device. Usually multiple factors affect the device performance. Therefore right validation is the key to prevent device recalls. The software associated with medical devices is getting closer scrutiny than ever before because of increasing prevalence in industry, greater chance for problems, and the comfort level of FDA investigators in asking for and auditing software applications.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Medical-Device-Software-Verification-Validation-Compliance-502448/DECEMBER-2017-ES-TRAININGREGISTRY
  • 17 Request Info

    Webinar on Complying with 'Made in USA' Labeling Standards

    Marketers and manufacturers that promote their products as Made in USA must meet 'all or virtually all' standard under Federal Trade Commission requirements or face stiff penalties. 'Made in the USA' is an attractive claim, not only for consumers, manufacturers and marketers, but for regulators, attorneys and plaintiffs as well. This audio conference presentation offers an overview of the FTC's 'Made in the USA' labeling requirements and enforcement policies.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/Complying-with-Made-in-USA-Labeling-Standards-508732/DECEMBER-2017-ES-TRAININGREGISTRY
  • 18 Request Info

    Webinar on Microsoft Outlook Calendars and Tasks: Tips to Improve Your Time Management Skills

    You can do more with Microsoft Outlook than just email! You probably use calendars in Outlook to keep track of meetings and appointments. But, do things sometimes seem like they're getting away from you? Are scheduling conflicts and missed meetings just a fact of your work life? Here's some help. 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/Microsoft-Outlook-Calendars-and-Tasks-Tips-to-Improve-Your-Time-Management-Skills-508514/DECEMBER-2017-ES-TRAININGREGISTRY
  • 19 Request Info

    Webinar on How The New Lease Accounting Standards Will Impact Your Business - Are You Prepared for the New Regulations?

    The new standard from FASB, which goes into effect on January 1, 2019, includes the obligation to publish comparable figures for three consecutive years (so 2017, 2018, and 2019). This means organizations need to be prepared now. 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-The-New-Lease-Accounting-Standards-Will-Impact-Your-Business-Are-You-Prepared-for-the-New-Regulations-504410/DECEMBER-2017-ES-TRAININGREGISTRY
  • 20 Request Info

    Webinar on Critical Thinking and Creative Problem Solving for a better Decision Making

    Learn to make effective decisions and solve problems using critical thinking and simple, practical tools. You make decisions and solve problems every day. Learn how to apply critical thinking techniques to these activities.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/Critical-Thinking-and-Creative-Problem-Solving-for-a-better-Decision-Making-507142/DECEMBER-2017-ES-TRAININGREGISTRY