Webinars Available on CD
Webinars held over the past three years are now available for purchase on CD. The CDs include the complete audio of speaker presentations, audience question and answer sessions, and printed copies of the materials.
- Current Insights on the Regulatory Requirement to Validate Production and Quality System Software
- Implementing Human Factors Principles and Best Practices in Medical Device Design: Lessons Learned
- Implementing Risk Management into the Design of Electrical Medical Devices
Assists medical device manufacturers with the application of risk management, usability engineering, and the design of alarm systems as required by the third edition of 60601-1. - Importance of Effective Medical Device Reporting
For companies that continue to struggle with the decision making process if identifying when an adverse event should be reported, have trouble making MDR decisions due to difficulty in interpreting key terminology, or are looking for industry and FDA guidance on the MDR process. - Linking Human Factors with FDA's Quality System Regulation: A Critical Component to the Design and Manufacturing Process
Offers information on how to integrate Human Factors Engineering into a quality system, gives clarification on how to validate and verify human factors design at different stages of the product development cycle, and provides better understanding of FDA expectations on identification and analysis of use error and risk management. - New Global Standard for Sterile Medical Device Packaging - ANSI/AAMI/ISO 11607 - Part 1 and 2
Based on the ANSI/AAMI/ISO 11607 series on packaging standards, the three webinars examine the requirements and test methods for materials and preformed sterile barrier systems, and covers validation requirements for forming, sealing, assembling, and packaging medical devices that are terminally sterilized. - Overview of New Risk Management Standard: ANSI/AAMI/ISO 14971:2007
The program provides an overview of the changes to the industry risk management standard. Speakers also explain the philosophical approach, organization, and relationship of the 2007 edition to other standards.
- Planning for a Successful Submission
Provides an overview of the different types of submissions, offers tips on the submission process and how to communicate with FDA before and during the review phase, and reviews new compliance guidance documents. - Process and Logistics of Internal Quality Auditing in a Regulatory Environment
This webinar examines the requirements, techniques, objective evidence, and logistics involved in internal quality auditing that supports your company’s Quality Management System. - Purchasing Controls: Best Practices in a Regulated Environment
Addresses the industry's need for further education on how to create a robust purchasing control system that complies with FDA's Quality System regulation. - Quality Matters Series: The Nuts and Bolts of Management Review
Offers guidance on how best to conduct a meaningful management review that is dynamic, productive, and compliant with the Quality System regulation. - Quality Matters Series: Thwarting Nonconformity: CAPA vs. Preventive Action
or quality assurance and regulatory affairs professionals, this webinar covers topics ranging from process validation and risk management processes to combination products and FDA inspections. - Reprocessing Medical Devices: Current Standards, Guidance, and New Developments in Validating, Cleaning, Disinfecting, and Sterilization Processes
Examines the current standards and guidance for cleaning, disinfecting, and sterilizing medical devices. - Risk
Management and Analysis in a Regulated Environment: Process
to Prevent, Mitigate, Control, and Reduce Your Risk
Serves as a supplement to AAMI’s Integrating Risk Management Into the Quality System course. This program will provide companies with information on how to take the step from understanding how to be compliant with the requirements of 14971 and the Quality System regulation to utilizing a critical thought process to assist in mitigating risk. - Role of Executive Management in Quality System Compliance
Ideal for busy executives of medical device manufacturers — presidents, vice presidents, directors, board members, and major department heads — who are ultimately responsible for quality system compliance. The program gives a broad overview of FDA's quality system requirements that Executive Management is responsible for overseeing. - Sterility
Assurance Levels for Medical Products Based on ANSI/AAMI ST67:2003 Requirements for Products Labeled 'STERILE'
Addresses the basic building blocks of sterilization and the decision-making steps a company should go through before implementing sterilization processes. This program is essential for those responsible for identifying Sterility Assurance Levels (SALs), defining sterilization validation goals, and ensuring compliance with international regulations and standards. - Successfully Navigating an FDA Inspection
For companies who want more information on how to prepare for a FDA inspection, what happens during an inspection, and what to do and how to respond to FDA after receiving the inspection results. - What Has Changed for EO Sterilization? A Comparison of the 1994 and 2007 Versions of ANSI/AAMI/ISO 11135-1