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

This course will prepare you to manage multiple auditors and audit teams for audits with multiple evaluation paths (tracks). This includes How to prepare your Audit Leaders and Subject Matter Experts (SME), How to prepare your Back Room (Work Room) staff, How to prepare a comprehensive schedule to ensure the right people are in the right place at the right time during the audit. Although this course is focused on multiple track audits for the Medical Device or Life Sciences industry, the process and tools defined in this course can be applied to any audit.

This 90-minute webinar will cover principles and provide examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. It will provide you with the knowledge and understanding needed to improve patient safety and also to prepare your organization for regulatory inspections.

Learn the basic overview of the international medical device Quality Management System -- EU’s Quality Management System under ISO 13485:2016. Implementation, training requirements, content and annual internal audit / inspection expectations.

This webinar on Estimating Reliability Performance of products will show how you can use Accelerated Life Testing methods (ALT) to reduce costs, minimize risks and ensure adequate product performance prior to launch.

This FDA audit webinar will highlight the purpose of FDA audits and scope, Understanding of QSIT audit and how to develop an audit preparedness plan. It will also give understanding of what the FDA will look for at the conclusion of your audit and how to communicate with FDA before and after the audit.

This webinar will help you to establish a Quality Management System (QMS) for Medical Device Companies. A well-structured QMS meets the requirements of the Quality System Regulations and is both effective and efficient. The regulations require that manufacturers “establish and maintain a quality system that is appropriate for the specific medical device(s) designed and manufactured”. In order to “establish” a suitable and effective QMS, medical device companies must be able to “say what they do, do what they say, and prove it”!

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.