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

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.

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.

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.

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.

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 webinar on avoiding serious FDA 483s will explain FDA's changed audit focus based on recent top 483 findings and provide practical tips on how to better prepare your company's internal audit program to avoid serious Form 483 observations.

This Medical device training will acquaint one with the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.

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.

Cloud computing has become perhaps the most critical compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantee that management will expect compliance strategies to be developed that will support decisions to utilize cloud environments to perform regulated activities. This presentation will provide a baseline of information related to cloud computing which will help attendees better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.

This training program will discuss CDISC requirements to create SDTMs and ADaMs. It will also offer essential mapping and strategy concepts for creating and validating SDTM and ADaM variables in key CDISC datasets (DM, AE, ADSL, and ADAE).

This webinar will review types of training requirements from the FDA and ISO 13485 for medical device employee. It will discuss techniques for monitoring and documenting training effectiveness.

In this medical devices security webinar you will learn how to establish a Product Security Program that help your organization to put the right people, processes, and technology in one place to solve the changing landscape of connected medical devices and the risks that are associated with the new environment. It will also highlight the medical device security leading best practices the industry has been implementing to not only meet regulatory requirements but also increasing customer’s needs.

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU. It includes specific insights from direct involvement and work within the EU and the Commission's major improvement objectives to their system today. Areas of change between the prior Medical Device Directive (MDD) and the MDR will be discussed as well as expectations for how to implement ISO-13485:2016.

This 2-hour webinar will cover the basics of design controls for medical devices. Design Controls are an integrated set of management practices that are customer focused and ensure quality and consistency. An effective and efficient design control process results in a predictable product development process with improved quality and compliance result. This webinar can help you create a design control process that is a competitive strength for your company.