Medical Device Regulatory Compliance Training - Live Webinars, Recordings & CDs

This training session is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. The program will provide effective and practical solutions to address real-world issues.

This webinar will help you to develop strategy and objectives for an effective and efficient Quality Management System (QMS) for Medical Device Companies. A suitable and effective Quality Management System requires a thoughtful and methodical approach to create and execute. This webinar will help medical devices companies understand their current state and strategy for improvement. If you’ve had serious quality issues, compliance problems, or are dealing with the costs of an inefficient QMS, this webinar is for you.

This documentation training will explain regulatory ramification of communication done through Lab books, SOPs, DHF, technical files etc and how to reduce it.

This webinar will explain how to create Failure Mode Effects Analysis (FMEA) by combining Effective Information Collection (EIC), Process Reliability Modeling (PRM) and Failure Mode Effect Criticality Analysis (FMECA). It will also cover the methods for determining root causes of process problems and effective tools for repair of ineffective processes.

Attend this webinar to get an overview of the Health Canada Medical Devices Regulations and its requirements. Also, get guidance on how to approach MDEL and Device Licensing, Renewals and Costs.

This training program is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Through case study analysis, the course will examine best practices to provide thoughts and ideas to develop or improve the CDISC mapping system.

This training on combination product regulations will evaluate the chief areas of concern or change in the new CGMP requirements for combination products, 21 CFR Part 4, and clarify many of the issues and questions that arise involving combination products.

This sterilization validation process training webinar will review the FDA or ISO requirements for tests following validation and emphasis is placed on the appropriate tests for validation, the appropriate routine tests and the frequency of testing.

This webinar provides an understanding of coating systems in general, differences in how coatings are applied, what their weak points might be and how to assess the properties that are appropriate for their needs. The new document ISO 17327 will be discussed and controversies that form from potential use of that document will be assessed.

This webinar will help you to develop a Quality Management System (QMS) for Medical Device Companies. An effective QMS sends a message to the FDA and other regulators that your QMS is complete, accurate, and consistently followed. More importantly, it ensures that your personnel can consistently and accurately meet requirements resulting in correct outcomes and quality work.

This training program will assist anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this training. Effective and practical solutions to address real-world issues will be detailed.

You may find out after seven or more months of waiting that the 510K has been denied because the software portion of the submittal is inadequate and not compliant. Don’t let that happen. This webinar will teach you how to submit compliant and adequate software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. Also, learn how to avoid the potential audit risk which might prevent you from selling the approved product if you have been found to not have an IEC62304 Compliant Software Quality System.

This Medical Device Security webinar will focus on industry leading practices to assist healthcare delivery organizations (HDOs) with the integration of security into medical device procurement to inform procurement decisions, contractual requirements, and compensating controls. Also attendees will learn the required steps involved in the procurement process, some of which include vendor-level and product-level assessments, contractual requirements, and publicly available resources to assist with standardization.

This Sterilization training will provide valuable information to companies that design products for terminal sterilization with ethylene oxide.

In this webinar attendees will learn the QSR and ISO 13485 requirements for document control and the ideas associated with the development and control of quality documentation. Also attendees will get knowledge on methods and practices that will improve the clarity and control of your document control system. Effective GMP documentation practices will be reviewed to ensure your paperwork is clear, complete, and easy to understand.

This presentation will cover the FDA regulations (21 CFR Subpart G Section 820.70) regarding production and process controls and how each requirement listed within the regulation can be addressed. We’ll go over examples of documentation you can use to fulfill the requirements of this section, as well as tips and tricks to what FDA auditors will look for when they come to visit your site. We will also go over some additional tips and tricks on how to convey the importance of maintaining production and process control within your organization and ensure resources are provided to meet process needs. At the end of the presentation, I will answer any questions or concerns you may have regarding FDA requirements.

This webinar on supplier controls will provide you the information you need to assure your supplier management program is in compliance with the latest FDA, European and international guidelines requiring a risk-based supplier management program. We will look at how to improve your supplier management system to meet both the FDA and ISO expectation while potentially reducing your cost of compliance.

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 focuses on the verification and validation planning and execution of software, after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf) and the growing field of "cloud"-based software. A suggested FDA model (mandated for submissions) will be evaluated, implemented, with V&V documentation and test case examples. Also attendees will learn the most recent issues the FDA has had in this area, and remediation approaches.

This training program will explain the rationale, the legal requirements and some methods commonly used for reprocessing and validating reusable medical devices.