Education Technology

If you can't find what you want, Ask Us.

Refine Your Results

reset

Filter by Category

Location

Dates

FEATURED VENDORS

Showing 41-60 of 221 results Sort by:

Courses

  • 41 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.
  • 42 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.
  • 43 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.
  • 44 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.
  • 45 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.
  • 46 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.
  • 47 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.
  • 48 Request Info

    Software Risk Management 2018

    Risk Management is a regulatory and statutory requirement for medical devices. The generic procedure to perform risk management is outlined in ISO14791, however, as soon as software is used challenges arise. How to address these specific software issues and the application of FDA and IEC requirements for development of safety-critical software used in medical devices is the content of this seminar.
  • 49 Request Info

    Assessing and Planning for Risk (Latest 2018)

    The larger, more complex, and longer your project is, the more likely some aspects won't work out as you envisioned. You have the greatest chance for success if you confront the possibility of unexpected changes head-on and if you plan how to minimize the consequences of those changes from the outset.
  • 50 Request Info

    Project Management for Non-Project Managers (2018 Estimating Resource Needs)

    Overview: After developing your schedule, you need to plan your resource allocation. Planning your personnel needs begins with identifying whom you need and how much effort they have to invest. This analysis provides you with a clear description of accountability and responsibility, a way to track costs and work assignments, and an identification of when too many or too few resources are being assigned.
  • 51 Request Info

    CAPA for Medical Devices 2018

    You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you. In this 3-hour webinar, you'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you.
  • 52 Request Info

    What are the Tools required for Human Error Reduction

    Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.
  • 53 Request Info

    Design Control is Critical to Product Quality

    This 90-minute webinar will cover the basics of design controls for medical devices. Design Controls are an integrated set of management practices that are customer focused and ensure quality and consistency. This webinar can help you create a design control process that is a competitive strength for your company.
  • 54 Request Info

    Historical Perspective of the Part 11 Regulation

    Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation.Understanding the requirements of Part 11 is critical to compliance with the regulation.Knowledge of regulatory requirements is an exercise in efficiency both efficiency in project management, and avoidance of non-compliance penalties.
  • 55 Request Info

    DHF, DMR, DHR, TF , Design Dossiers - The Requirements

    This webinar will examine the existing and proposed requiements for the U.S. FDA's DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3 including its derivitive documents, the DMR and DHR. It will consider the European Union's MDD TF/DD and its transition to the EU MDR requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
  • 56 Request Info

    Learn the Essentials of Dealing with Non-Conforming Material

    Non-conforming material happens. And medical device companies must deal it. This 90-minute webinar will help you to make sense of confusing regulations and effectively deal with non-conforming material. You'll learn how to identify, segregate, control, and disposition non-conforming material. You'll learn about conducting failure investigations and requirements for correction and corrective action. Join industry expert, Susanne Manz from Manz Consulting Inc, to learn the essentials of dealing with non-conforming material.
  • 57 Request Info

    A Detailed Introduction on Statistical Process Control

    However, all production processes exhibit variation that is, no two items are identical. What method can be used to reduce such variation? The classic and still most widely used method is called SPC or "statistical process control".
  • 58 Request Info

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

    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, It will also detail GMP standards and requirements pertaining to compressed air quality, and will discuss cause and effect, also prevention of the contamination.
  • 59 Request Info

    Compliance for Computer Systems Regulated by FDA

    The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. FDA's 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed.
  • 60 Request Info

    How to Prepare and Manage FDA Inspections

    This course is designed to provide participants with an understanding of the purpose of FDA Inspections, the consequences of not complying with their requirements and how to prepare and manage these types of inspections. It will provide details on each topic from the course outline.