Medical Devices
How to Prepare for and Host a FDA Inspection and Respond to 483’s
In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection ( front room, back room), the value of mock audits, how personnel should conduct themselves, the inspection process and how to respond to 483s and warning letters. How to respond and when is critically impo..
How to Write SOP’s for Human Error Reduction
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. Procedures play a vital role in human reliability. Nevertheless, it is essential to understand human behavior and the psychology of error as well as underst..
Human Error Reduction in GMP & Manufacturing Floor
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be 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 occurrenc..
Human Error Reduction Techniques For Floor Supervisors
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar. People make mistakes because they can; our systems allow it. To work with these challenges, it is essential to understand human behavior and the psychology of error as well as understand exactly where the ..
Human Factors and Ergonomics in New Product Development: Methods and Technique
Human factors engineering is extremely integral to user/market adoption. Getting a product to market is difficult whether you are a struggling startup or an established original equipment manufacturer (OEM). Understanding some of the tools available on the front end of product development can help you avoid downstream problems before they become time and money wasters. Human factors engineering is one such ..
Human Factors/ Usability following ISO 62366 and new FDA Guidance
Human Factors/Usability is an analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating results with the device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to t..
IEC 62304 for Medical Device Software
This course is essential for Medical Device companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. One of the biggest risks most company's face when submitting their device for approval is finding out after seven or more months of waiting that the 510K has been denied because the software portion of the submittal is inadequate and no..
Implementing a Quality Management System
The Quality Management System (QMS) is a set of policies and protocols for the acceptable operation of an organization that contains laboratories that must comply with US FDA GLP. Examples of roles and responsibilities, useful metrics, and tools to monitor performance, and useful documentation will be given.Learning ObjectivesGLP RegulationsQuality Management System (QMS)DefinitionPrinciplesPurposeFunctionE..
Implementing a Robust Data Integrity Program
Data integrity is defined as the maintenance of, and the assurance of the accuracy and consistency of, data over its entire life-cycle. Data Integrity is a global issue with both FDA and the European Regulatory Agencies majorly focusing on the topic during compliance inspections. Multiple FDA warning letters and EU GMP non-compliance reports have highlighted major data integrity failures and falsification w..
Implementing Appropriate Quality Metrics and Key Performance Indicators (KPIs)
Establishing appropriate Quality Assurance metrics is important for several reasons. Metrics not only measure the health of your quality system, but they also have the ability to change behavior, drive quality culture, and improve both individual and company performance. This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to ..
In Depth Testing of Computer Systems Regulated by FDA
We will discuss the importance of applying industry best practices when performing the validation process for a computerized system used in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution process). Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly. Testing is a very large co..
Internal Audit for Medical Device Companies
Internal Audit should be a key part of self-awareness and understanding strengths and weaknesses within your Quality Management System. It should be an essential guide to corrective and preventive action and drive improvement. But it doesn’t always work that way. In this webinar, we’ll cover the reasons internal audit doesn’t work and how you can correct that. This webinar will explore how to improve your i..
International Codes and Medical Device Reporting
The US FDA receives over 100,000 reports a year of medical device adverse events including deaths, serious injuries, and malfunctions. Because of this high number of reports, the FDA sought ways to sort the data using hierarchical coding systems that included a device problems code; a manufacturer’s evaluation for the event: methods, result, and conclusion; and also information on the patient and the device..
Is Your Quality Management System Up to Date for the New European Medical Device Regulation Starting in May 2020?
The EU MDR 745/2017 is a complete game-changer to the old law of the MDD 93/42/EEC since 1993 with a couple of updates. The time is very short and the number of requirements and required changes is high. The training will show, how to conduct a gap analysis, an action plan and how to be on track until May 2020. Learn, what to do into the quality management department and what to do in the regulatory affairs..
Legal, Regulatory and Policy Issues Related to Validation of Computer Systems Regulated by FDA
We will discuss the importance of applying industry best practices when performing the validation process for a computerized system used in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution process). Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly. There are legal, regulator..