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

This training program will highlight mistakes often made when corrective and preventative actions are not clearly identified and applied during a manufactured product sterility test failure investigation because an ineffective investigational procedure and tool was used to conduct a sterility test failure investigation. The webinar will also illustrate how avoiding such common mistakes will ensure that these types of products meet the sterility requirements USP <71> and other regulatory guidelines applicable to finished products, bulk drug substance, raw materials or excipients.

This 6-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You’ll gain insights into the regulatory expectations, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls. You’ll learn how to streamline and monitor your process to ensure compliance and improved performance.

This webinar will focus on the key regulatory requirements for medical devices for the participating MDSAP countries of U.S., Canada, Brazil, Australia and Japan. It will address key topics such as device classification, licensing pathways, medical device GMP, inspections, device labeling, license holder responsibilities and more.

This FDA investigation training program will deconstruct best practices for handling unannounced FDA visits, responding to a 483 or a warning letter, and the effect of an FDA investigation. The program will also discuss basic concepts that should be employed by everyone regulated by the FDA and define processes for preparing for FDA audits.

This webinar will provide you a thorough background into the FDA regulatory and EU control issue related to the specific device required to provide expert opinions.

This webinar will discuss the basics of product registration in Mexico, Brazil and Argentina such as Registration Timelines, documentation requirements and governmental processes.

This webinar will help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers. You will gain an understanding of the regulations and learn to translate them into an efficient and effective process for purchasing/ supplier control. You will learn about the essential elements of purchasing control and how to translate them into your procedures, prevent quality and compliance problems by having a strong system for Purchasing Controls. We’ll discuss the process steps for purchasing control and how it relates to other parts of your QMS including receiving and acceptance activities.

Premarket Approvals Premarket approval (PMA) are required by The Food and Drug Administration is the regulatory protocol presently used to evaluate the safety and effectiveness of Class III medical devices, e.g., an implantable cardioverter defibrillator (ICD). This webinar will help you understand the nature, severity, or frequency of suspected problems reported in adverse event reports or in the published literature. The information when applied is most effective in reducing potential adverse events.

This webinar will discuss the basics of product registration in Saudi Arabia and MEA such as Registration Timelines, documentation requirements and governmental processes.

Verification and validation are important elements of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn which processes needed to be validated and what steps are required 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. A validated process is optimized ensure predictable and improved quality and compliance results.

The third revision of ISO 14971 will be released in Q4, 2019. Upon release it will cancel and replace ISO 14971:2007. In this webinar you will learn what has changed and how to prepare for compliance to the new Standard.

This webinar will discuss what actions should be taken following a positive result in a sterility test on a biological indicator (BI) during performance qualification or routine testing. It will also explain the various items that should be investigated to determine the root cause and the follow up to the investigation.

This webinar will cover strategies to improve the efficiency of your Quality Management System (QMS) for medical device companies. It will get you started in setting up a quality system that reduces compliance burden. We’ll. discuss techniques for improving efficiency, reducing burden, and still maintain an effective QMS.

Non-conforming material happens. And medical device companies must deal it. This 90-minute webinar will help you to make sense of confusing regulations and effectively deal with non-conforming material. You’ll learn how to identify, segregate, control, and disposition non-conforming material. You’ll learn about when and how to conduct failure investigations and requirements for correction and corrective action.

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.

Learn the basic overview of the international medical device Quality Management System -- EU’s Quality Management System under ISO 13485:2016. Implementation, training requirements, content and annual internal audit / inspection expectations.

This webinar on Estimating Reliability Performance of products will show how you can use Accelerated Life Testing methods (ALT) to reduce costs, minimize risks and ensure adequate product performance prior to launch.

This FDA audit webinar will highlight the purpose of FDA audits and scope, Understanding of QSIT audit and how to develop an audit preparedness plan. It will also give understanding of what the FDA will look for at the conclusion of your audit and how to communicate with FDA before and after the audit.

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”!