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

This FDA Good Documentation Practices training will introduce and explain the concept of Good Documentation Practices, and provide real-world examples of how to, and how not to, use GDPs.

This Validation of Bioanalytical Assays webinar describes logical approaches to efficiently develop assays that will deliver quality data.

This 6-hr webinar on Reliability Engineering Fundamentals for Medical Devices will cover the science and techniques for designing highly reliable medical devices at lower cost and in lesser time.

This 4 hour training will focus on best practices in design reviews and show how you can add high value to your products and processes by improving the performance while reducing the life cycle costs significantly.

This training will outline practical steps to design medical device software that does not compromise on performance reliability and patient safety, thereby preventing product recalls.

The presentation will consider potential impacts of the rule on regulated and unregulated vendors, and providers. This session will survey the market affected by the proposed rule, and define the common components and capabilities of these systems.

This cGMP webinar for medical device companies will focus on recent manufacturing lapses that have resulted in major recalls, multi-million dollar fines and some criminal charges. It will analyze why they happened and show how to prevent it.

In this medical device training on Importing and Exporting learn and understand the import and export process for unapproved and approved medical devices and the documentation process involved. Examine the import and export requirements and ensuring compliance success.

Attendees will receive a detailed understanding of process validation for medical devices approach employing IQ, OQ, and PQ. You will learn the information to include in the protocols and reports, the role of Statistical Process Control (SPC), using Design of Experiments (DOE), attribute sampling plans as a verification method, and a discussion of the GHTF document on process validation.

Understanding the GHTF guidance document is particularly important, since FDA (CDRH) plans to issue it as a guidance document in FY2011.

Learn about the proposed Device Establishment Registration and Listing rule and how to meet the FDA requirements and expectations.

The following is a pack of 4 best-selling training CDs for sales, marketing & regulatory professionals in the Medical Device industry. These courses provide solutions for all critical challenges & questions faced by you and your team pertaining to regulations/compliance, best practices, etc.

This Sterilization validation training will review the general requirements for validation as described in ISO 11137:2006.

This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement. Attend this webinar to know what happens in a recall and what are the strategies and operational procedures in a recall.

This training on Software Development Standard IEC 62304 will provide you key insights on how to understand IEC 62304, and how to use the standard to help you uncover software related GMP violations.

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.

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 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 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.