GXP Medical Devices Training

This webinar will discuss the main regulatory regimes for medical devices in US, Canada, Brazil, Japan and Australia, how they differ from EU CE mark regulations and how to address compliance though a Medical Device Single Audit Program (MDSAP) and ISO 13486:2016 approach

This FDA investigation training program will deconstruct best practices for handling unannounced FDA visits, responding to a 483 or a warning letter, and the effect of an FDA investigation. The program will also discuss basic concepts that should be employed by everyone regulated by the FDA and define processes for preparing for FDA audits.

This training program will examine the approval process for drugs, biologics and devices and elaborate FDA submission requirements and guidances. It will also discuss electronic regulatory submission and gateway for FDA and FDA eCTD guidance and specifications.

This webinar will discuss the role of Process Challenge Devices (PCDs) both during ethylene oxide (EO) validation and during routine processing. It will explain the difference in requirements for PCD during both the processes.

This webinar will discuss the regulatory requirements and the processes, tools and techniques for conducting an effective risk and hazard analysis for medical devices as per FDA, FTA, FMEA, and FMECA guidelines.

This training program on applicable regulations pertaining to clean room environmental monitoring (EM) programs will discuss the basics of setting a robust and effective EM program. The course will also detail the relationship between an EM Excursion Program and CAPA and the four phases of clean room transitional monitoring.

In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also attendees will learn in detail about the System Development Life Cycle (SDLC) methodology used to approach Computer System Validation (CSV), including all of the phases, sequencing of events, deliverables, and documentation requirements.

This training program will focus on how cell cultures are used for in vitro assays. It will include examples of cell based assay systems and list the advantages of cell based assays. The webinar will help attendees understand the uses of in vitro testing with eukaryotic cell based systems, the parameters to be considered in the development and optimization of a cell based assay and the validation of a cell based assay.

This webinar will define human factors engineering and its role in the success of new product development. The session will use real world examples to demonstrate how human factors engineering makes a significant.

A tougher U.S. FDA expects a company to maintain certain documents in equipment, process and product software V&V. These documentation requirements can assist in a 21 CFR Part 11 CGMP records / signature V&V as well. This training program will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software V&V activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance, past problems, and the growing cloud environment. It will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will allow attendees to develop and use a repeatable software V&V template for all software validation projects.

Medical Device Tracking is a very important aspect of the distribution chain of a medical device. This is because it is critical to have a mechanism by which a medical device can be traced and located in its place after it leaves the manufacturer. This system of tracking helps to identify a defective device and ensure that corrective measures are taken immediately.

This webinar, by an ex-FDA, will cover Good Data Integrity Practice for GxP environments. Participants will understand what FDA looks for with regard to data integrity, what may need to be audited, the new guidance and application of data integrity, and relevant regulations for data integrity

The course is designed to review critical elements of the new regulations and will be run as an interactive 2 hour course designed for business leaders with a good working knowledge of current requirements.

This training will provide an understanding of graphical tools used to identify multiple populations or failure modes. Attendees will learn how to estimate product reliability for multiple populations using Minitab® v17.

This Post-market Surveillance (PMS) webinar will discuss in detail the clinical evaluation and risk management requirements as described in MedDev 2.7/1 Rev. 4, EN ISO 14971:2012 and EN ISO 14971:2012 standards and how they are related. It will also explain some of the recent changes in EU medical device regulations.

This webinar will teach you how to design, build and test medical device software in preparation for the successful 510k submissions. It will cover medical device software user requirements, software architecture, design, unit testing and more.

This webinar will provide an overview of mobile medical apps and discuss when the app becomes the FDA regulated medical device. It will also discuss the cybersecurity requirements for mobile apps.

This training program will examine how human factors/usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it 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 the new ISO 62366 standard and the new FDA guidance document.

This webinar will cover FDA’s current thinking on QRM and Guidance for Industry - Q9 Quality Risk Management, provide information to help understanding of QRM concepts, and applications. In addition, brief review of how ICH Q8, Q9, and Q10 work in coherence throughout product lifecycle.

This webinar will focus on the recent changes to the ISO 9001 and ISO 13485 quality management system (QMS) standards. Participants will be provided with the tools necessary to help their company plan for the transition to the new editions.