Medical Device Regulations and Guidance Training - Live Webinars, Recordings & CDs

This training program will assist those responsible for planning, executing or managing the integration of a business system with any laboratory system governed by FDA regulations. On completing the program, attendees will have an understanding of laboratory system computer validation planning, execution and management concepts, and how they apply to any integrated business system.

This training program will provide professionals with essential elements of CAPA investigations to assure compliance with regulatory requirements. The corrective and preventive action (CAPA) program is an essential element of a compliant quality management system, as required by international regulations and voluntary standards. Investigations are the backbone of the CAPA program.

The training program will prepare attendees to better understand the revisions to this standard as they read its requirements in detail. For those organizations that have a QMS that's compliant with ISO 13485:2003, you will benefit from this program as it will help you assess your preparations.

The webinar will discuss the current available regulatory pathways to develop FDA-regulated 3D printed products and also predictions on what to expect in the near future. 3D printing in personalized treatments will be discussed and attendees will be provided practical tips for pursuing approval with the FDA.

This training course will provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of life science products (pharmaceuticals, medical devices, biologics and combination products) as an importer or producer in Russia. It will offer a deeper understanding of cultural norms, and will discuss best practices for establishing relationships and protecting your intellectual property to be integrated into your company’s training and corporate business strategies.

This webinar will explain how to apply the theory of lean documents and its corollary theory of lean configuration to present a fresh approach to these linked and cascading documents.

This training program will discuss key terms and responsibilities related to FDA inspections and the purpose of the BIMO inspection program. It will also review the general purpose and overall process of an FDA inspection and enhance your inspection preparation strategies.

This training program will provide a review of the current testing requirements and discuss what happened to the old 87/91 LAL Guidance for Industry proposed guidance. The program will also discuss how to transition from one bacterial endotoxin test to another—understanding the RPT (Rabbit Pyrogen Test). Participants will also gain a clearer perspective of the Monocyte Activation Test (MAT).

This training program will provide attendees with the ultimate set of tools in order to help their firms properly create User Requirement Specifications (URS) for Computer Systems Validation (CSV) with emphasis on current industry trends in this particular area as well as current Food and Drug Administration (FDA) regulatory trends and enforcement activity.

In this training program, attendees will learn how process robustness tools and metrics can be utilized to enhance process understanding and control. The new FDA paradigm is shifting to the expectation that organizations certified by other standards such as ISO and EFfCI demonstrate process robustness. It is the obligation of the primary pharmaceutical provider to ensure process robustness throughout the supply chain.

This training program will illustrate the underlying idea that makes ANOVA work. It will also offer an understanding of the data collection issues you should plan and how to get access to ANOVA in Excel.

This 90-minute webinar will review FDA's draft regulations for UDI and describe the new requirements for labeling medical devices. It covers the new regulations in 21 CFR Part 830, the changes to Part 820, the Quality System Regulation; Part 801, Labeling; Part 803, Medical Device Reporting; Part 806 Corrections and Removals; and other regulations.

Attendees will come away from the training program with the tools they need to understand the various types of enclosures and how to select the correct type of enclosure for their process in order to meet regulations, protect the product, and ensure worker safety. The course is apt for personnel in FDA regulated industries who want to learn about what enclosure is best suited for their process and why.

This training program will enumerate the inspection process for API, drug and device manufacturers and summarize recent changes. It will guide attendees on preparing staff for the new FDA inspections and discuss the role of exit meeting to avoid enforcement.

This webinar will review FDA’s regulations related to suppliers in manufacture of drugs, biologics and medical devices. It will discuss the current regulations, guidance documents and best practices for supplier management and enforceable quality agreement using case studies for a variety of scenarios. Common FDA audit findings will be discussed.

This medical device webinar will discuss strategies for meeting the Post Market Surveillance requirements as described in Annex X of the MDD (MDD 93/42/EEC, updated per the 2007/47/EEC M5 amendment, Annex 1: Essential Requirements), MEDDEV 2.7.1, Dec 2009 and ISO 14155.

This training program will dispel mistaken paradigms regarding the risk based approach to water system lifecycle. It will detail how to eliminate variability – the cause of most deviations. Attendees will learn how to capitalize on the advantages of online analytical instrumentation (chemical and microbiological rapid methods).

This webinar will focus on the new requirements of EU Medical Device Directive Essential Requirements Checklist (ERC). It will also explain the relationship between ERC, Clinical Evaluation Report and Technical File.

This training program will furnish attendees with an overview of the EU vigilance system and the understanding and tools necessary for effective QMS implementation. It will also provide an implementation checklist for the vigilance system.

This webinar will discuss the disclosure requirements for clinical investigators under the Sunshine Act. It will discuss the details of the processes; provide templates for reporting formats; and timelines for reporting.