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

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.

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.

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.

Almost every paragraph of the Quality System Regulation states that manufacturers shall “establish” procedures. Well written SOPs that are easy to understand and follow are necessary to accomplish that objective. Excellent SOPs need more than just subject matter. This webinar will help you to write complete, clear, unambiguous, and flexible SOPs. You will learn techniques for creating concise and easy to read SOPs that your employees can understand and will follow. Well written SOPs result in more consistent process outputs and quality results.

This training will provide valuable knowledge on what companies need to do to establish an "effective" Compliance Office that leads to conceiving, developing and implementing successful GRC programs and provides top level coordinating leadership for governance, risk management and compliance issues across the enterprise.

This webinar will make your understand regulatory requirements of veterinary medical device. How to differentiate regulations of human and veterinary medical devices, manufacturing requirements, safety standards, labelling requirements, how to draft the SOPs covering material intake, production, quality control, packing, distribution and sales.

This webinar will cover creating of a value-added internal auditing program that is compliant to FDA cGMP/ Quality System Regulation and ISO 13485. It will include how to set up and manage the auditing system as well as how to conduct an internal audit and document the results and any nonconformities. It will discuss the value of a good internal auditing program.

Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.

FDA regulated industries can prophet by understanding the regulatory power of FDA and incorporating this knowledge into their daily routine. Time and resources spent preparing for the inevitable inspection will pay back proportionately. By doing your homework and putting simple principles to work you can minimize the negative effects of FDA’s power and put everyone in your organization at ease. By understanding the risks inherent in your products, you can develop a quality system that will align your operation with FDA’s expectations. Why live in fear when you can rest at night knowing you are ready?

This environmental excursion investigation training will review the various items that should be included in the investigation to determine the cause of the limit excursion for both viable and non-viable excursions.

This CAPA training program will provide an understanding of FDA and ISO requirements, steps in CAPA process and the challenges associated to root cause analysis. Attendees will learn the tools and quality data sources to use during root cause analysis investigation.

This training program will provide regulatory requirements (US) of 21 CFR Section 820.50 (purchasing control) for the medical device industry and illustrate the same with examples. It will furnish details on what purchasing/supplier control management systems should address.

Learn about change control process and procedures in regulated industries. This webinar help you understand and successfully apply change control steps and best practices.

Whether you are being audited or conducting and audit, understanding the fundamental is critical for both quality system and regulatory compliance. In this webinar we will examine the concepts of conducting audits and being the subject of an audit (internal or external).