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

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.

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 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.

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 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).

This webinar will discuss and define GXP’s, where the variable “x”, is Laboratory, Clinical, or Manufacturing. The webinar will focus on the requirements for each, and how they relate to the total product lifecycle, compliance, and inspections.

This webinar will provide an overview of the FDA expectations in medical device industries for setting up a quality system for FDA audit readiness. It will also provide an understanding of the quality system inspection techniques (QSIT) requirements for documents controls, production and process controls, packaging and labeling controls and more.

This webinar will focus on "non-traditional" medical device markets, challenges to market access including competitors and government regulation or lack thereof. Outside of the most developed countries, there are many areas in the world, not as developed, where registration and marketing of medical devices is extremely lucrative. These include: Latin America (LATAM), Asia Pacific (APAC), and The Middle East (EMEA).

This session will focus on conducting a risk/benefit analysis of both the positive and potential negative impact of the advancement of AI and ML devices in the medical device industry. It will provide a further understanding of the FDA's current thinking on the implementation of regulatory policies to ensure safe and effective medical devices that advance the quality of life of the patient. Artificial intelligence technology is rapidly spreading across the medical field, as systems are being developed that can identify signs of illness and disease in a wide variety of imaging situations such as MRI and CT. AI devices are complex with respect to algorithm used in their development, information being input in to the systems in which they learn, and the recommended out from such learning.

This webinar pulls together current US FDA and UK MHRA guidance covering medical devices and diagnostic tests during the current COVID-19 emergency. Particular emphasis will be given to ventilators and other respiratory aids within the medical device topic.

This webinar will discuss the multi-faceted aspects of bringing a medical device to market. The webinar explores topics ranging from market concept to post-market surveillance. Entering a medical device market involves more than engineering and regulatory compliance. Companies need to consider a variety of issues to successfully enter the medical device market.

Attend this webinar to learn about the new EU legal requirements for exporting medical devices to the EU. Learn how to prepare for this MDR requirement and include options for selling your device in the EU and the U.S.

This training program will provide the regulatory requirements (US) for complaint handling in the medical device and pharmaceutical industries. The course will touch on complaint sources, and details will be furnished on the interrelationships regarding complaint handling/change control/adverse event reporting/and recalls. The course will also include timeline requirements associated to adverse event reporting, which reporting formats to use, when to recall and types of recalls.

This webinar will demonstrate methodologies for obtaining competitor information to use for the establishment of equivalence. You will also learn how to monitor changes in the global regulatory medical device landscape.