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.

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 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 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.

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

In this webinar attendees will learn the basic understanding of the regulations listed within 21 CFR Part 820, how to apply regulations into your company documentation, describe the must-have systems required for your QMS, Also attendees will learn how to develop a checklist plan for ensuring all elements of the regulations are incorporated into your QMS, and better understand the scope of what will be needed to meet FDA requirements.

This training program will highlight key differences between SDTM and ADaM models and process flows. It will also focus on key differences between the seven CDISC classes and on best practices to create Dataset.XML from SAS. Attendees will gain a better understanding of the structure and syntax of ODM-XML files as well.

In this training program, attendees will learn quick formatting tips that will make writing more readable and learn how to use formatting tools in a way to maximize the impact of their writing in an electronic system.