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Medical Device Cybersecurity

A Guide for HTM Professionals
AAMI Member:
$155.00
List Price:
$232.00
Your Price:
$232.00
↑/↓ Full Details


Medical Device Cybersecurity (PDF)

A Guide for HTM Professionals
AAMI Member:
$155.00
List Price:
$232.00
Your Price:
$232.00
Available for Immediate Download
↑/↓ Full Details


Personnel Safety in Sterile Processing Departments Video

This 60-minute instructional video provides information essential to the promotion of personnel safety in sterile processing departments.

Earn 1 credit hour CE through CBSPD and IAHCSMM.

The script was written by P. Richard Warburton, PhD, JD; CTO & General Counsel, ChemDAQ, Inc. It includes practical guidance on:
- Legal duties and who's who among the relevant regulatory agencies and professional organizations
- Common hazards encountered in the sterile processing department
- Bloodborne pathogens and infection prevention
- Proper selection, use, and disposal of personal protective equipment (PPE)
- Relevant standards that pertain to the use of PPE, steam and chemical sterilization, and ethylene oxide
- Safe storage, handling, and disposal of contaminated items and chemical agents
- Key elements of engineering controls that promote safe handling of sterilants and high-level disinfectants
- Appropriate labelling of chemicals
- Responsibilities of employers and staff in preventing, managing, and reporting accidents in the workplace
AAMI Member:
$132.00
List Price:
$220.00
Your Price:
$220.00
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Preparing For Success: Acute Hemodialysis Survey Readiness

This webinar promotes understanding of the applicable survey requirements and provides guidance in ways to build readiness so that acute hemodialysis services can be prepared for success in any inspection.
AAMI Member:
$15.00
List Price:
$20.00
Your Price:
$20.00
Available for Immediate Download
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Process Validation Requirements and Industry Practice-April 2019

images/Events/901-Glebe.jpg
Description: This 2.5-day course provides attendees with practical tools and techniques for process validation requirements for FDA’s Quality System regulation and recognized Process Validation Guidance from the Global Harmonization Task Force. The program includes industry best practices and real-life process validation examples. Demonstrate Return on Investment (ROI) to employers by completing and passing the Process Validation Post-Course Test. This optional, one-hour, self-assessment tests your mastery of the course materials and your ability to correctly interpret the Quality System regulation. This optional post-test which is available online for 2 weeks following the end of the program, will be available to all participants.

 Registration Fees:

  • AAMI Members: $2135
  • Nonmembers: $2435
  • Government Employees: $950

 

 

Program Outline

 


DAY 1 | 8 AM-5 PM
Intro to Process Validation Requirements & Their Relationship to Design Controls
Master Validation Planning
Installation Qualification & Software Validation 

Operational Qualification


DAY 2 | 8 AM-5 PM
Operational Qualification Continued
Performance Qualification
Implementation & Documentation


DAY 3 | 8 AM-12 PM
Monitoring & Control 
Revalidation
Advanced Planning & Validation Strategies 






 

 

Program Objective

Upon completion of this course, participants will be able to: determine which processes require validation and develop a Master Validation Plan; develop protocol content to ensure a successful validation; document the results and the resolution of deviations that occur during validation; plan for effective monitors and controls for the validated processes; and determine the revalidation requirements for product and process changes.

 

Target Audience

Instruction is geared to professionals involved with process validation in the medical device industry such as R&D Team Members, Quality Engineers, Quality Assurance Managers, Design Engineers, Project/Program Managers, and Process Engineers. To maximize the peer learning opportunity, AAMI recommends this course for those who already have a basic understanding of the Quality System regulation and have some relevant work experience.

 

Format

This 2.5-day program provides intensive coverage of process validation and includes a variety of real-life examples, case studies, and exercises that cover process validation activities. These exercises provide participants with the opportunity to apply new information to actual validation scenarios. The course includes a general description of statistical methods and tools as they relate to process validation.

 

Materials

Fee includes a printed copy of the textbook, The Quality System Compendium, and electronic versions of the PowerPoint presentations and case studies, pertinent FDA documents, additional references, and access to the online exam.


Start Date:
Tuesday, April 16, 2019
End Date:
Thursday, April 18, 2019
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
Address:
AAMI Center for Excellence (ACE)
901 North Glebe Road Suite 300
Arlington, VA 22203
UNITED STATES
AAMI Member
$950.00 - $2,135.00
List Price
$950.00 - $2,435.00


The Quality System Compendium: CGMP Requirements and Industry Practice, Third Edition

Since the 2007 publication of the second edition, there have been substantial changes in medical device technology, medical device regulatory approaches, and FDA and international guidances and standards. This new third edition has been developed to provide accurate and useful information to the medical device community, updated to reflect the current status of the many rapidly evolving areas of the medical device environment.

AAMI Member:
$390.00
List Price:
$650.00
Your Price:
$650.00
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Wi-Fi Enabled Healthcare

Focusing on its recent proliferation in hospital systems, Wi-Fi Enabled Healthcare explains how Wi-Fi is transforming clinical work flows and infusing new life into the types of mobile devices being implemented in hospitals.
AAMI Member:
$85.00
List Price:
$108.00
Your Price:
$108.00
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Writing a Human Factors Engineering (HFE) Report

In 2011, the U.S. Food and Drug Administration (FDA) released a draft guidance document, Applying Human Factors and Usability Engineering to Optimize Medical Device Design, and this guidance calls for medical device manufacturers to include an HFE report when they apply for a 510(k) or PMA. The FDA goes so far as to provide a relatively detailed outline for the HFE report. However, many manufacturers are likely to have persisting questions about how to write an effective report.
AAMI Member:
$135.00
List Price:
$225.00
Your Price:
$225.00
Available for Immediate Download
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Writing Human Factors Plans and Reports Webinar

This webinar will fill a perceived gap in the guidance available to medical technology developers with sample work products and supplemental job aids that offer document preparation advice and have been peer-reviewed by a panel of HFE experts.
AAMI Member:
$149.00
List Price:
$249.00
Your Price:
$249.00
Available for Immediate Download
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