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

Overview of Design Control for Medical Devices, with an emphasis on design inputs. Seminar will go over regulations, basic concepts in design control and importance of design inputs and how to write appropriate inputs.

Based on lean manufacturing and documentation concepts, this webinar deconstructs the supplier quality remediation process.

The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations. This webinar will provide valuable assistance and guidance to the life sciences manufacturers engaged in various aspects of product complaint investigations.

This webinar will focus on the computer systems and data that are regulated by FDA. These systems will require validation and the data must be created and maintained with integrity. We’ll cover what is required for Computer System Validation (CSV) and we’ll discuss the new draft guidance from FDA on Computer Software Assurance (CSA). We’ll also cover 21 CFR Part 11, FDA’s guidance for electronic records and electronic signatures. Finally, we’ll discuss the “ALCOA+” requirements for data integrity.

This Software Auditing Procedure training will discussion on FDA software Standard “General Principles of Software Validation”, Actual FDA investigator software auditing techniques for software failure investigations.

This Webinar will describe, explain and clarify the differences between DHF, DMR and DHR . It will also detail the requirements and the expected contents of each record.

Both the U.S. FDA and EU's MDR expect documented risk-based equipment, process,systems and procedures development, integration and maintenance.

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidance. This happens because the FDA approves the final, validated version of the software. The point of AI/ML is to learn and update the following deployment to improve performance. Thus, the field version of the software is no longer the validated approved version.

New and Realistic Lean Manufacturing can be a key to company success, by incorporating basic lean principles, while addressing FDA / CGMP requirements.

We will discuss the importance of complying with FDA requirements for validation of systems using technologies that have been emerging for the past couple of decades. While FDA is planning to overhaul their own infrastructure to gain efficiencies, they are also encouraging industry to take advantage of newer technology and systems. These include cloud-based systems, Software-as-a-Service (SaaS), artificial intelligence, and others.

We’ll talk about taking a risk-based approach to validation, and how to implement newer capabilities such as electronic records and electronic signatures. We’ll also cover the importance of meeting data integrity compliance.

Compliance with European Medical Device Regulation 2017/745 (MDR) is mandatory for all medical devices placed in the market in any member state of the European Union. It is of strategic importance for any medical device manufacturer to understand and effectively apply the MDR requirements to access this critical market.

Both the U.S. FDA and EU's MDR expect documented calibration and risk-based V&V under U.S. FDA cGMPs, the EU MDR, ICH Q9 and ISO 14971

Fundamental requirements for process validation in both FDA QSR and ISO 13485. Learn when a process should be validated, the basic components of a process validation (IQ, OQ, and PQ) and how to write protocols and reports.

This webinar will provide valuable guidance to regulated companies in development and implementation of Design Control Planning and Techniques for new or heavily changed product development under 21 CFR 820.30, "Design Control", and ISO 13485 7.3. Also regulatory compliance proof of "progress against plan", and other activities requiring a planned documented rationale. It should be an important part of a company's IP (Intellectual Property).

Data integrity refers to the accuracy, completeness, and consistency of data over its entire lifecycle. Data integrity is crucial for any organization as it ensures that the data they rely on to make decisions is trustworthy and reliable. This topic discuss the importance of data integrity in regulated industries, such as pharmaceuticals and medical devices.

This Water system compliance training/webinar focuses on the factors that can lead to water system sanitization success as well as failure so that the user can not only devise workable sanitization approaches.

This Spread Sheet Validation training/ webinar explains FDA requirements for Excel spreadsheets used in production or the quality system. The regulations come from 21 CFR §820.70(i) Automated Processes and 21 CFR Part 11.

This Medical device training is a section-by-section review of ISO 13485 in a clear concise manner, and provides suggestions for development of a compliant system.

This Water system compliance training will guide you through the changes to implement to Validate Water system and better understanding of quality specifications and process control levels, as well as the microbiology of water systems.

This Medical device quality audits training review the process used by FDA to perform inspections of medical device manufacturers and will provide advice for quality and regulatory personnel that required providing information to an FDA inspector.