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Courses

  • 21 Request Info

    3-Hour Virtual Seminar - Good Pharmacovigilance Practice

    Refund Policy This course aims to provide basic training for those concerned with pharmacovigilance, This course has been planned to provide you with the essential skills and tools to prepare and host a regulatory inspection and to facilitate the response and follow-up to the inspection outcome, findings (483s) and the necessary Corrective Actions and Preventive Actions (CAPA).
  • 22 Request Info

    Validation of Laboratory and Process Analysis Instrumentation

    Overview: How to choose/make standards: Lab-based standards are most often synthetic, with final forms tested for extraction of all the analyte Process samples are most often final product, scanned spectroscopically, then analyzed via a referee method. Process stds may be made synthetically, but several precautions need to be taken.
  • 23 Request Info

    Verification vs Validation-Product, Process or Equipment and QMS Software

    Overview: The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.
  • 24 Request Info

    3-Hour Virtual Seminar on Data Integrity - FDA's Latest Thinking

    Overview: This webinar will give you the tools that you need to ensure that you understand data integrity issues and best practices for ensuring data integrity at your company. Why should you Attend: The FDA is increasingly focusing on data integrity issues, including data manipulation, when conducting facility inspections. Concerns over data integrity issues have resulted in the agency adding companies to the for-cause inspection list, and the FDA has found questionable data during in a significant number of these for-cause inspections. The FDA is noticing some electronic data manipulation in parts of its inspection program and is focusing on training its investigators to be more alert to data manipulation, Branding said.
  • 25 Request Info

    Managing and Controlling the Project - Project Management

    The subject of this webinar is building the project team, The key to achieving success with your project is the people you assign to it, how well you develop the team, and sustaining team member's ongoing commitment to the successful completion of the project, Also you will learn This process includes developing team and individual team member goals, determining the team's operating processes, and building strong team member relationships.
  • 26 Request Info

    Reducing Training Related Errors (Human Error Trainings)

    This course will provide insights into current knowledge of human error and how it can be reduced, The course will provide hands-on experience of practical error reduction techniques, using real-life case studies, You will also gain an understanding of the underlying causes of human error and how to reduce its occurrence by changing the culture of the organization and changing the design of the processes.
  • 27 Request Info

    Computer System Validation 2018 Fundamentals

    This session will address the specific way of documenting your computer system validation work to ensure it meets FDA requirements and can pass an inspection, also this webinar will help you understand the FDA's requirements for good documentation, including how to handle change control and the importance of audit trails, you will learn how to create and maintain good documentation that meets FDA compliance standards.
  • 28 Request Info

    What's Changing for Life Science Product License Holders (BREXIT)

    Overview: The United Kingdom submitted its' notification on 29 March 2017 to withdraw from the European Union. This means that unless a withdrawal agreement establishes another date, all EU primary and secondary Laws cease to apply to the UK from 30 March 2019 going forward. The UK, by definition would become a "third country". Preparing for the withdrawal doesn't just involve the Healthcare Authorities, but every manufacturer and /or license holder of a pharmaceutical, biologic, medical device or combination product in the UK and EU.
  • 29 Request Info

    Information Technology - Control Procedures in Regulated Industries

    In this webinar, change control procedures within quality management systems (QMS) for documentation and information technology systems will be discussed, And you will learn about change control process and change control procedures as they apply to documentation and information technology systems in regulated industries.
  • 30 Request Info

    FDA New Draft Guidance on (Software) and Device Changes 510k

    Overview: A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA. The FD&C Act and the 510(k) regulation (21 CFR 807) do not specify who must submit a 510(k). Instead, they specify which actions, such as introducing a device to the U.S. market, require a 510(k) submission. You will learn about Substantial Equivalence to support a 510(k) submission.
  • 31 Request Info

    What you need to know to Meet FDA and International Quality Standards

    Overview: This webinar will take you through the primary sources of compressed air contamination. It will also detail GMP standards and requirements pertaining to compressed air quality. Why should you Attend: Compressed air is often overlooked as a potential source of clean room and product contamination. This webinar will give you an understanding of the different types of contamination inherent in compressed air and how to prevent each from affecting your particular system.
  • 32 Request Info

    FDA's enforcement of 21 CFR part 11 compliance

    Overview: This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome. In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.
  • 33 Request Info

    Computer System Validation (CSV) for FDA-Regulated Computers

    Overview: 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 webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards. You'll learn about the various computer system validation deliverables and how to document them through the entire process. You will learn about what must be done to ensure the system remains in a validated state. In addition, you'll learn all about how to create and maintain good FDA-compliant documentation using a strategic approach based on the System Development Life Cycle (SDLC) Methodology.
  • 34 Request Info

    Standard Operating Procedure (SOP) and Work Instructions (WIs)

    Overview: This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.
  • 35 Request Info

    US Regulatory Submissions and Publishing 101: Keys to Success

    Overview: Effective regulatory strategy, like product design, requires "quality-by-design" approach and planning throughout the product development lifecycle. For pharmaceutical, device, and biotechnology companies, understanding how to effectively design and manage a regulatory submission can lead to a more efficient application development process and greatly increase the likelihood of marketing authorization.
  • 36 Request Info

    Requirements and Compliance Processes for Life Sciences

    Overview: This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
  • 37 Request Info

    MDUFA IV - An Introduction

    In this webinar speaker will review the user fees themselves in more detail and discuss the performance goals established as a result. And finally, she will devote the bulk of this presentation to highlighting the program areas addressed with the passage of MDUFA IV.
  • 38 Request Info

    FDA's New Enforcement of 21 CFR Part 11 2018

    FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 related observations. Citations are related to inadequate integrity, security and availability of electronic records, including data manipulation. There are many questions about the ongoing inspection and enforcement program, e.g., what inspectors are looking at, what are major findings and what are the FDA expectations about follow up.
  • 39 Request Info

    A Guide to Building a Safety Culture 2018

    The Behavioral Based Safety system (BBS) is a valued tool used in conjunction with other safety and health aids, such as, job hazard analysis, fault tree analysis, audits, and inspections. The BBS focuses on the behavior of the worker which is measurable and observable, unlike a person's attitude. When behavior which can cause accidents and organizational loses are observed, the BBS system will give aids to the safety officer in coaching safe behavior. The final output of an effective BBS system is to create a safety culture.
  • 40 Request Info

    Validation of Non-Product Software 2018

    In this webinar We will explain the role of Risk Management in Non-Product Validation, understanding how to avoid major mistakes when validating software to FDA standards, This webinar will review the validation planning process with emphasis on avoiding common pitfalls, The attendee should leave the presentation confident in their ability to improve the level of validation success.