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

The meanings and regulatory requirements of the terms “verification” and “validation” are often confusing to engineers and even some regulatory professionals. FDA regulations as well as European standards such as ISO 13485:2003 require both verification & validation documentation throughout these regulations and standards. The terms apply to design control, process control and others. This presentation will define and explain the differences (& similarities) in these terms and how they apply to regulated industries as well as the consequences of poor adherence.

This course will cover validation essentials for medical device manufacturers. Attendees will learn about what processes needed to be validated and what steps you need to take to validate processes. You’ll learn the essentials of validation planning, protocol writing, and change management. We’ll cover the steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.

This webinar will provide understanding of FDA and ISO 13485 requirements for process validation and how to implement them.

This webinar will provide you the information you need to create supplier quality agreements (QA Agreements) with key suppliers and to understand which of your suppliers should have these agreements to meet expectations of the FDA and ISO 13485 Notified Body auditors.

This session will include the requirements for all of the complaint handling responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "non-complaint" feedback. Also covered will be the application of risk management to a complaint handling system, and a specific risk management system explained.

Validation is an important element of the Quality System Regulations and ISO 13485. This course will cover the validation essentials for medical device manufacturers. You’ll learn about what processes needed to be validated and what steps you need to take to validate processes. Validation is a powerful tool in understanding, optimizing, and controlling manufacturing processes. We’ll cover the essential steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.

In this webinar, you will how to manage General Safety and Performance Requirements (GSPRs) according to EU MDR 2017/745 Annex I for full compliance with new EU Medical Device Regulation mandatory starting 26-May-2021

This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.

Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers. This 90-minute webinar will cover the basics of design controls for medical devices.

In this webinar, you will learn how to manage custom-made medical devices according to EU MDR 2017/745 and fully comply with the new EU Medical Device Regulation which is mandatory starting 26-May-2021.

This 90-minute webinar will examine in detail the U.S. FDA and EU MDD requirements for DHFs, DMRs, DHRs, and TF/DDs - their formats, content, and their commonalities, differences, interrelationships, and similarities.

The one-hour training discusses the major elements that should be considered prior to, during, and after the performance of a dose audit. The training is designed to instruct attendees on how to critically think about the preparation, performance, reporting, and responding to failures for a dose audit.

In this webinar, you will learn how to classify medical devices according to EU MDR 2017/745 Annex VIII for full compliance with new EU Medical Device Regulation mandatory starting 26-May-2021

This webinar will benefit medical device companies planning to have a CE mark under the European Union Directive 93/42/EEC. We will discuss what is new in ISO 14971:2019 and help you avoid delays in obtaining or maintaining your CE mark for compliance to the Medical device Directive, EU Directive 93/42/EEC on Medical Devices.

This session will discuss the requirements for Management Controls, including organizational structure, internal audits, establishment of a quality policy and confirmation it is being followed, establishment and contents of a quality system.

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources. In these companies, CAPA is a 4 letter word. This webinar will help you avoid identify the symptoms of this common problem. Learn how to avoid those struggles and establish an efficient and effective CAPA process leading to improved quality and compliance for your company. You’ll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you.

In this quality management system webinar attendees will learn the recent changes to ISO 13485:2016 standard in step by step process and how to implement these changes in their current quality management system to pass the quality management audit. Also attendees will gain knowledge on how to deal with ISO 9001 or any other quality management system in multidisciplinary quality management systems.

This life science product stability testing webinar will explain, in detail, the requirements of the FDA’s drug stability guidelines that are stipulated for drug products and how to design a product stability testing plan that can be applied to new or modified products in the pharmaceutical, biotechnology and medical device industries.

This webinar addresses managing GMP Complaints and Adverse Event Reports related to drug products, biologicals, and medical devices. The relevant regulations will be discussed.

In this webinar you will learn how to create detailed quality agreements (QA Agreements) for key suppliers, particularly those for outsourced processes, and to understand which of your suppliers should have these agreements to meet the expectations of the FDA and ISO 13485:2016 and MDSAP. The agreements discussed will meet the expectations of the GHTF and NBOG supplier guidance documents which are now an expectation of both the FDA and most ISO 13485 auditors. These supplier QA agreements can be an important part of demonstrating that you have control of your key suppliers.