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Courses

  • 1 Request Info

    Make Your FDA Inspection as Painless as Possible

    In this session will be the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits. Without adequate preparation and cross-functional communication, it is difficult to manage a good FDA inspection. Your goal is to illustrate your firm is in substantial compliance with all regulations, but also to respond to the inspector's questions or concerns in a timely manner. This webinar will identify systems and processes, and recommended tactics, to make the inspection as painless as possible.
  • 2 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.
  • 3 Request Info

    Fishbone Diagramming

    Overview: Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability. Specific areas presented: Look for Evidence The Post-it Exercise Pareto Chart Fish Bone Diagramming Process Reliability Modeling
  • 4 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.
  • 5 Request Info

    3-Hour Virtual Seminar on The "New NAFTA": The USMCA

    Overview: The North America Free Trade Agreement (NAFTA) comprises Canada, the U.S. and Mexico, an agreement which has eliminated barriers to trade, promoted conditions of fair competition, increased investment opportunities, provided protection for intellectual property rights, and established procedures for the resolution of disputes. The United States-Mexico-Canada Agreement (USMCA), commonly referred to as the "New NAFTA,"is essentially NAFTA 2.0. The USMCA has been adjusted to include changes for automakers, stricter labor and environmental standards, intellectual property protections, and digital trade provisions.
  • 6 Request Info

    Equipment Validation, Tracking, Calibration and Preventive Maintenance

    Overview: FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include: intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements. Prior to use, however, this equipment must be validated to make sure it produces product that meets its specifications. There are ways, though, to validate equipment already in use.
  • 7 Request Info

    Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices

    Overview: This webinar will help you understand the critical ingredients for conducting an effective root cause analysis. You will learn about FDA expectations, tools and techniques, and tips for conducting and documenting root cause analysis. We will discuss the myths, challenges, and best practices for this critical process. We'll also cover the essentials of doing a failure investigation. Why should you Attend: CAPA is the cornerstone of quality improvement and it depends on an effective root cause analysis. Conducting an effective root cause analysis (RCA) can be a daunting task. And without a good root cause analysis, your CAPA will not result in the desired improvement.
  • 8 Request Info

    GMPs for APIs

    Overview: In this webinar we will discuss the regulatory expectations that apply to the production and control of active pharmaceutical ingredients. The discussion will start with the introduction of ICH Q7, the internationally accepted GMP for APIs, discuss the international regulatory and compliance issues associated with this GMP and each of the main areas of ICH Q7 to include: personnel, buildings and facilities, process equipment, documents and records, materials, production and production controls, packaging, and laboratory controls.
  • 9 Request Info

    Project Management for Non-Project Managers

    Overview: This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject. Why should you Attend: It is not possible to present a complete treatment of project management in the span of 60-90 minutes. It is however possible to focus in on those most critical project management aspects that are critical to the success of any project. Without basic tools, it is not possible to effectively manage a project to the pre-determined end-date without turmoil and chaos.
  • 10 Request Info

    2-Hour Virtual Seminar on Mastering Excel Pivot Tables

    How to compare two or more fields in a variety of layout styles How to sort and filter results How to perform ad-hoc grouping of information How to use Slicers instead of filters to identify which field elements are displayed How to drill down to see the details behind the summary How to categorize date/time data in multiple levels How to create a Pivot Chart that is in sync with a PivotTable
  • 11 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.
  • 12 Request Info

    Attend this session to learn how to effectively manage the negotiation process and techniques for the communication skills.

    Attend this session to learn how to effectively manage the negotiation process and techniques for the communication skills. 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/Negotiation-Skill-Building-For-The-Banker-Ask-For-The-Business-Close-The-Deal-509150/NOVEMBER-2019-ES-TRAININGREGISTRY
  • 13 Request Info

    Trends for Computer System Validation (CSV) Compliance and Enforcement

    Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation. They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to FDA. The attendees will have a good grasp of how to identify potential weaknesses and findings, as well as how to make recommendations for addressing and remediating them through risk mitigation.
  • 14 Request Info

    Understanding and Meeting your Regulatory and Processing Responsibilities

    The course will include the current review and enforcement climate within FDA and the manner, in which Drug Master Files (DMFs) are reviewed by FDA personnel. Besides the US, the use of DMFs in the EU, Japan, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted. The conversion of paper to e-filings requirements with FDA will also be discussed. The process used for e-filings will be reviewed in detail. Maintaining filings for Annual Reports and DMF Amendments will also be covered.
  • 15 Request Info

    The Interplay of the Americans With Disabilities Act

    The intersecting of these three laws is complicated and open to problems if not handled correctly. ADA, FMLA and Workers Compensation have different goals and protections for employees, yet all three have provisions that may require an employer to give job-protected time off when the right circumstances are met.
  • 16 Request Info

    FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

    Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation. They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to FDA. The attendees will have a good grasp of how to identify potential weaknesses and findings, as well as how to make recommendations for addressing and remediating them through risk mitigation.
  • 17 Request Info

    4-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.
  • 18 Request Info

    HR 101

    This program will give basic compliance information that will reduce risk and help participants become more confident in communicating with employees regarding common HR issues, Participants should attend this webinar if they are new to HR, want a high-level refresher on HR compliance, or are new to management and supervision.
  • 19 Request Info

    Using Statistics in Compensation

    This webinar will explain the statistics behind pay program design and administration like how to create and analyze pay range widths and understanding the statistics of pay structure design
  • 20 Request Info

    No - Panic Presentation Skills for Executives

    Overview: This webinar highlights best practices for executives and industry leaders who want to speak up and stand out in both formal and informal settings.