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AAMI CP - Combination Products Committee Meeting

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AAMI CP - Combination Products Committee, will be meeting at the new AAMI Center for Excellence in Arlington, VA on April 12, 2019.

Please register below. Registration is necessary to ensure proper accommodations.

ALL attendees, whether in-person or by phone, will be REQUIRED to register for this meeting. Web/teleconference details will be provided to registrants after registration closes, on April 10, 2019.
You must log in or create a profile in order to register.

Please note: you will receive an emailed receipt of your registration. If you don't get this receipt, please contact AAMI Standards.

All meetings will be held here:
AAMI Center for Excellence
901 N. Glebe Road, Suite 300
Arlington, VA 22203

Click here for a list of local hotels


Date:
Friday, April 12, 2019
Time:
9:00 AM - 5:00 PM Eastern Daylight Time
Address:
901 North Glebe Road
Suite 300
Arlington, VA 22203
UNITED STATES
AAMI Member
$0.00
List Price
$0.00


AAMI CV - Cardiac Valve Prostheses Committee Meeting

https://my.aami.org/AAMIResources/images/events/Omni Riverfront Hotel New Orleans.jpg

AAMI CV - Cardiac Valve Prostheses Committee, will be meeting at the
Omni Riverfront Hotel in New Orleans, LA on March 12-14, 2019.
Please register below. Registration is necessary to ensure proper accommodations. Registration will close on March 6, 2019.

ALL attendees are REQUIRED to register for this meeting.
You must log in or create a profile in order to register.

Please note: you will receive an emailed receipt of your registration. If you don't get this receipt, please contact AAMI Standards.

Omni Riverfront Hotel
701 Convention Center Boulevard
New Orleans, LA 70130



Start Date:
Tuesday, March 12, 2019
End Date:
Thursday, March 14, 2019
Address:
Omni Riverfront
701 Convention Center Boulevard
New Orleans, LA 70130
UNITED STATES
AAMI Member
$0.00
List Price
$0.00


AAMI DP - Medical Device Particulates Committee Meeting

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AAMI DP - Medical Device Particulates Committee, will be meeting at the new AAMI Center for Excellence in Arlington, VA on April 17 & 18, 2019.

Please register below. Registration is necessary to ensure proper accommodations.


Due to space limitations, in-person attendance will be limited to Primary or Alternate members of the working group. A web/teleconference participation option will be available.
ALL attendees, whether in-person or by phone, will be REQUIRED to register for this meeting. Web/teleconference details will be provided to registrants after registration closes, on April 15, 2019.
You must log in or create a profile in order to register.

Please note: you will receive an emailed receipt of your registration. If you don't get this receipt, please contact AAMI Standards.

All meetings will be held here:
AAMI Center for Excellence
901 N. Glebe Road, Suite 300
Arlington, VA 22203

Click here for a list of local hotels


Start Date:
Wednesday, April 17, 2019
End Date:
Thursday, April 18, 2019
Address:
901 North Glebe Road
Suite 300
Arlington, VA 22203
UNITED STATES
AAMI Member
$0.00
List Price
$0.00


AAMI Exchange 2019

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Description: AAMI has changed the name of its premier health technology event from the AAMI Annual Conference & Expo to the AAMI Exchange. The new name and brand promise reflect the Association's commitment to connect the full gamut of AAMI stakeholders—biomedical and clinical engineers, technicians, cybersecurity and sterilization experts, and hospital administrators and managers and the industry's leading service and solution providers. The Exchange will provide a forum for broad conversations among these stakeholders on the ever-changing industry of medical technology.
AAMI Exchange 2019 is the premier destination for global leaders and health technology professionals aspiring to improve health by advancing the safe and effective use of technology.

The AAMI Exchange 2019 will take place in Cleveland, OH.

Hotel Reservation Link


Start Date:
Friday, June 07, 2019
End Date:
Monday, June 10, 2019
Address:
Huntington Convention Center of Cleveland
300 Lakeside Avenue
Cleveland, OH 44113
UNITED STATES
AAMI Member
$0.00 - $750.00
List Price
$0.00 - $950.00


AAMI SM-WG05 Device Security Working Group

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AAMI SM-WG05, Device Security Working Group, will be meeting at the new AAMI Center for Excellence in Arlington, VA on June 10 & 11, 2019.

Please register below. Registration is necessary to ensure proper accommodations.


A web/teleconference participation option will be available.
ALL attendees, whether in-person or by phone, will be REQUIRED to register for this meeting. Web/teleconference details will be provided to registrants after registration closes, on June 5, 2019.
You must log in or create a profile in order to register.

Please note: you will receive an emailed receipt of your registration. If you don't get this receipt, please contact AAMI Standards.

All meetings will be held here:
AAMI Center for Excellence
901 N. Glebe Road, Suite 300
Arlington, VA 22203

Click here for a list of local hotels


Start Date:
Monday, June 10, 2019
End Date:
Tuesday, June 11, 2019
Address:
901 North Glebe Road
Suite 300
Arlington, VA 22203
UNITED STATES
AAMI Member
$0.00
List Price
$0.00


AAMI/BSI/FDA International Standards Conference - April 2019

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The AAMI/BSI/FDA International Conference on Medical Device Standards and Regulation will be held on 24-25 April 2019 at the Hyatt Regency Reston, 1800 Presidents St, Reston, VA 20190.  The conference will provide updates and analysis of new FDA initiatives and European Medical Device regulation and will review changes to key international standards.

Planned sessions will review:

  • Key FDA programs and initiatives, such as the standards recognition program, the digital health initiatives, and the single file program
  • Implementation of the European Medical Device Regulations (including the implications of Brexit)
  • The status of the Medical Device Single Audit Program, including a case-study of one manufacturer’s experience with MDSAP
  • Review of new guidance from the International Medical Device Regulators Forum, including guidance on the use of standards to support regulation and the new Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices
  • The future of Quality Management Systems, including the proposed FDA switch from 21 CFR 820 to ISO 13485 and prospective eventual alignment of ISO 13485 and ISO 9001
  • New cybersecurity laws or standards affecting medical devices from around the world.
  • Implications of the upcoming new edition of ISO 14155, Clinical investigation of medical devices for human subjects
  • The use of a full Product Life Cycle Approach in medical device regulations and standards
  • A review of progress in standards for health software and health IT (including the new provisional AAMI HIT1000 series for health IT systems, revision of IEC 62304 for health software and revision of the IEC/ISO 80001 series for medial IT systems)
  • Overview of developing standards and regulatory approaches governing artificial intelligence and machine-learning algorithms in medical technology. 
Breakout sessions will address developments in standards or regulations for UDIs, mobile applications and wearable devices, Amendment 2 to IEC 60601-1, the ISO 10993 biocompatibility series, sterile packaging, robotics, and combination products.

Register by February 8, 2019 and receive $25 off the listed registration fees. Discount applied at the time of registration.
$765 (AAMI Member)
$995 (Non-member)
$400 (Government Employee)


Book your hotel room today at the Hyatt Regency Reston: click here!
The deadline to receive the AAMI discounted hotel rate is Tuesday, April 2, 2019


Start Date:
Wednesday, April 24, 2019
End Date:
Thursday, April 25, 2019
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
Address:
Hyatt Regency Reston
1800 Presidents St
Reston, VA 20190
UNITED STATES
AAMI Member
$400.00 - $765.00
List Price
$400.00 - $995.00


AEM Workshop - Anaheim, CA

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AEM Workshop

April 15, 2019 | Anaheim, CA

AAMI members: $395 | Non-members: $455

AAMI will host another special, one-day forum in April for HTM professionals about AEM (Alternative Equipment Maintenance) programs as an efficiency and quality improvement strategy. The workshop boasts an interactive format and provides AEM guides and sample policies & procedures to attendees. Attendees will leave the workshop with a strong understanding for how to create and execute an AEM program which can immediately translate into significant time and cost savings for HTM programs and Healthcare Systems.  

The forum, featuring leading AEM experts, will be held 8:00 AM - 3:00 PM on Monday, April 15 at Kaiser Permanente Anaheim Medical Center.

Attendees will learn how to:

  • Execute a successful AEM program
  • Gain considerable cost savings, and
  • Comply with standards.

The training will be presented by AEM experts, Matt Baretich, PE, PhD, author of AAMI’s AEM Program Guide: Alternative PM for Patient Safety; and Frank Painter, CCE, MS, professor of the clinical engineering graduate program at the University of Connecticut.

It's ideally suited for HTM professionals; and directors of quality, IT, and facility engineering and safety.



Date:
Monday, April 15, 2019
Time:
8:00 AM - 3:00 PM Pacific Daylight Time
Address:
Kaiser Permanente Anaheim Medical Center
Medical Office Building 2 Conference Room: KM2-CC1
3440 East La Palma Avenue
Anaheim, CA 92806
UNITED STATES
AAMI Member
$395.00
List Price
$455.00


AEM Workshop - Cleveland, OH

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AEM Workshop

June 7, 2019 | Cleveland, OH

AAMI members: $395 | Non-members: $455

AAMI will host another special, one-day forum in June for HTM professionals about AEM (Alternative Equipment Maintenance) programs as an efficiency and quality improvement strategy. The workshop boasts an interactive format and provides AEM guides and sample policies & procedures to attendees. Attendees will leave the workshop with a strong understanding for how to create and execute an AEM program which can immediately translate into significant time and cost savings for HTM programs and Healthcare Systems.  

The forum, featuring leading AEM experts, will be held 9:00 AM - 4:00 PM on Friday, June 7 at Huntington Convention Center.

Attendees will learn how to:

  • Execute a successful AEM program
  • Gain considerable cost savings, and
  • Comply with standards.

The training will be presented by AEM experts, Matt Baretich, PE, PhD, author of AAMI’s AEM Program Guide: Alternative PM for Patient Safety; and Frank Painter, CCE, MS, professor of the clinical engineering graduate program at the University of Connecticut.

It's ideally suited for HTM professionals; and directors of quality, IT, and facility engineering and safety.


Date:
Friday, June 07, 2019
Time:
9:00 AM - 4:00 PM Eastern Daylight Time
Address:
Huntington Convention Center
300 Lakeside Ave E
Room 9
Cleveland, OH 44113
UNITED STATES
AAMI Member
$395.00
List Price
$455.00


AEM Workshop - Tampa, FL

http://my.aami.org/aamiresources/images/events/AEM Photo.jpg

AEM Workshop

March 14, 2019 | Tampa, FL

AAMI members: $395 | Non-members: $455

AAMI will host another special, one-day forum in March for HTM professionals about AEM (Alternative Equipment Maintenance) programs as an efficiency and quality improvement strategy. The workshop boasts an interactive format and provides AEM guides and sample policies & procedures to attendees. Attendees will leave the workshop with a strong understanding for how to create and execute an AEM program which can immediately translate into significant time and cost savings for HTM programs and Healthcare Systems.  

The forum, featuring leading AEM experts, will be held 8:00 AM - 3:00 PM on Thursday, March 14 at AdventHealth – Tampa.

Attendees will learn how to:

  • Execute a successful AEM program
  • Gain considerable cost savings, and
  • Comply with standards.

The training will be presented by AEM experts, Matt Baretich, PE, PhD, author of AAMI’s AEM Program Guide: Alternative PM for Patient Safety; and Frank Painter, CCE, MS, professor of the clinical engineering graduate program at the University of Connecticut.

It's ideally suited for HTM professionals; and directors of quality, IT, and facility engineering and safety.


Date:
Thursday, March 14, 2019
Time:
8:00 AM - 3:00 PM Eastern Daylight Time
Address:
AdventHealth-Tampa
Room-Auditorium
3100 East Fletcher St
Tampa, FL 33613
UNITED STATES
AAMI Member
$395.00
List Price
$455.00


Corrective and Preventive Action Requirements and Industry Practice-June 2019

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This 2 day course provides intensive coverage of the elements of a corrective and preventive action (CAPA) system. Some primary topics include: the purpose of a CAPA system and how it is integrated throughout a Quality Management System; appropriate data sources and how to coordinate, analyze and manage them; methods for verifying and / or validating actions; how to write good CAPA plans; how risk management is used in conjunction with the CAPA system; and 21 CFR and ISO 13485 requirements.

 

An optional exam is available online for 2 weeks following the end of the program.

Registration Fees:

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

 

 

Program Outline

 


DAY 1 | 8 AM-5 PM
Regulatory Requirements
Planning for the CAPA System
Measurement and Analysis
Improvement - Investigations



DAY 2 | 8 AM-5 PM
Improvement - Investigations
Improvement - Implementation
Management Reporting
FDA Perspective and Compliance









 

 

Program Objective

Upon completion of this course, participants will be able to evaluate their organization’s compliance with FDA’s requirements for establishing a Corrective and Preventive Action system. Further, they will be able to implement a compliant business value-added CAPA system to effectively manage existing and potential product and quality system nonconformities.

 

Target Audience

Instruction is targeted to quality assurance, quality system compliance and regulatory affairs professionals; personnel responsible for the implementation of CAPA systems; and CAPA system management.

 

Format

A combination of situation analyses, case study exercises, review of sample recall and warning letters, and both formal and informal discussions are used throughout the program to provide maximum opportunity for the application of information.

 

 

Materials

Fee includes PowerPoint presentations and case studies; relevant standards and technical information reports; pertinent FDA documents, additional references, and access to the online exam.


Start Date:
Tuesday, June 18, 2019
End Date:
Wednesday, June 19, 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


Design Control Requirements • Integrating the Quality System Regulation and ANSI/AAMI/ISO 13485 - December 2019

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This intensive 3 – day course provides complete coverage of design control requirements for FDA Quality System Regulation, ANSI/AAMI/ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP). With the participation of FDA representatives during the entire course, attendees have the unique opportunity to participate in a shared learning experience.

An optional exam is available online for 2 weeks following the end of the program.

Registration Fees:

  • AAMI Members: $2235
  • Nonmembers: $2535
  • Government Employees: $950

 

Program Outline

 


DAY 1 | 8 AM-5 PM 
Introduction to Design Control Scope and Applicability
Design Development and Planning
Design Input 

Risk Management
Design Output


DAY 2 | 8 AM-5 PM 
Design Review
Design Verification
Design Validation
Software Validation


DAY 3 | 8 AM-5 PM 
Design Changes 
Design History File
FDA Inspectional Approach
MDSAP





 

 

Program Objective

Upon completing this course, participants will be equipped with the information to able to evaluate the degree of compliance of a design control system, including identification of noncompliance issues, and be prepared to implement the improvements needed to meet requirements.

This highly interactive course engages the learner with in-depth discussion of industry best practices to learn how industry leaders address design control challenges. Exercises are designed to build a solid understanding for developing and applying design control requirements. Attendees will participate in structured discussions with their peers to develop solutions to solve current issues.

Examples of design control tools, templates, and practices, in use by medical device companies, stimulate discussion and provide a practical resource for future reference. Case studies and situation analyses are used throughout the program to help participants analyze potential areas of noncompliance, identify improvements, and evaluate the various methods of managing a design control program.

Course content is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturing companies, FDA, and industry consultants.

Target Audience

Instruction is targeted to professionals involved in meeting design control requirements such as those in regulatory affairs, quality assurance, design engineering, manufacturing, operations, and members of research and development or new product development teams.

 

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, December 10, 2019
End Date:
Thursday, December 12, 2019
Time:
8:00 AM - 5:00 PM Eastern Standard Time
Address:
AAMI Center for Excellence (ACE)
901 North Glebe Road Suite 300
Arlington, VA 22203
UNITED STATES
AAMI Member
$950.00 - $2,235.00
List Price
$950.00 - $2,535.00


Design Control Requirements • Integrating the Quality System Regulation and ANSI/AAMI/ISO 13485 - March 2019

http://my.aami.org/aamiresources/images/events/901-Glebe.jpg

This intensive 3 – day course provides complete coverage of design control requirements for FDA Quality System Regulation, ANSI/AAMI/ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP). With the participation of FDA representatives during the entire course, attendees have the unique opportunity to participate in a shared learning experience.

An optional exam is available online for 2 weeks following the end of the program.

Registration Fees:

  • AAMI Members: $2235
  • Nonmembers: $2535
  • Government Employees: $950

 

Program Outline

 


DAY 1 | 8 AM-5 PM
Introduction to Design Control Scope and Applicability
Design Development and Planning
Design Input 

Risk Management
Design Output


DAY 2 | 8 AM-5 PM
Design Review
Design Verification
Design Validation
Software Validation


DAY 3 | 8 AM-5 PM
Design Changes 
Design History File
FDA Inspectional Approach
MDSAP





 

 

Program Objective

Upon completing this course, participants will be equipped with the information to able to evaluate the degree of compliance of a design control system, including identification of noncompliance issues, and be prepared to implement the improvements needed to meet requirements.

This highly interactive course engages the learner with in-depth discussion of industry best practices to learn how industry leaders address design control challenges. Exercises are designed to build a solid understanding for developing and applying design control requirements. Attendees will participate in structured discussions with their peers to develop solutions to solve current issues.

Examples of design control tools, templates, and practices, in use by medical device companies, stimulate discussion and provide a practical resource for future reference. Case studies and situation analyses are used throughout the program to help participants analyze potential areas of noncompliance, identify improvements, and evaluate the various methods of managing a design control program.

Course content is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturing companies, FDA, and industry consultants.

Target Audience

Instruction is targeted to professionals involved in meeting design control requirements such as those in regulatory affairs, quality assurance, design engineering, manufacturing, operations, and members of research and development or new product development teams.

 

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, March 26, 2019
End Date:
Thursday, March 28, 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 - $2,235.00
List Price
$950.00 - $2,535.00


Design Control Requirements • Integrating the Quality System Regulation and ANSI/AAMI/ISO 13485 - September 2019

http://my.aami.org/aamiresources/images/events/901-Glebe.jpg

This intensive 3 – day course provides complete coverage of design control requirements for FDA Quality System Regulation, ANSI/AAMI/ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP). With the participation of FDA representatives during the entire course, attendees have the unique opportunity to participate in a shared learning experience.

An optional exam is available online for 2 weeks following the end of the program.

Registration Fees:

  • AAMI Members: $2235
  • Nonmembers: $2535
  • Government Employees: $950

 

Program Outline

 


DAY 1 | 8 AM-5 PM
Introduction to Design Control Scope and Applicability
Design Development and Planning
Design Input 

Risk Management
Design Output


DAY 2 | 8 AM-5 PM
Design Review
Design Verification
Design Validation
Software Validation


DAY 3 | 8 AM-5 PM
Design Changes 
Design History File
FDA Inspectional Approach
MDSAP





 

 

Program Objective

Upon completing this course, participants will be equipped with the information to able to evaluate the degree of compliance of a design control system, including identification of noncompliance issues, and be prepared to implement the improvements needed to meet requirements.

This highly interactive course engages the learner with in-depth discussion of industry best practices to learn how industry leaders address design control challenges. Exercises are designed to build a solid understanding for developing and applying design control requirements. Attendees will participate in structured discussions with their peers to develop solutions to solve current issues.

Examples of design control tools, templates, and practices, in use by medical device companies, stimulate discussion and provide a practical resource for future reference. Case studies and situation analyses are used throughout the program to help participants analyze potential areas of noncompliance, identify improvements, and evaluate the various methods of managing a design control program.

Course content is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturing companies, FDA, and industry consultants.

Target Audience

Instruction is targeted to professionals involved in meeting design control requirements such as those in regulatory affairs, quality assurance, design engineering, manufacturing, operations, and members of research and development or new product development teams.

 

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, September 24, 2019
End Date:
Thursday, September 26, 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 - $2,235.00
List Price
$950.00 - $2,535.00


Effective Application of Agile Practices in the Development of Medical Device Software - September 2019

http://my.aami.org/aamiresources/images/events/901-Glebe.jpg

Registration Fees:

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

 

Program Outline

 


DAY 1 | 8 AM-5 PM
Agile Benefits
Agile Principles and Practices
Barriers to Agile Adoption
The Regulatory Perspective
Aligning Agile with your Quality System
Interpreting the Manifesto
Mapping Agile to Regulations
Design Inputs
Planning


DAY 2 | 8 AM-4 PM
Verification and Validation
Managing the Dynamic Nature of Agile
Design Reviews
Documentation and Traceability
Team Practices
Risk Management








 

 

Program Objective

Upon completion of this 2-day course, participants will be able to evaluate the challenges with the use of Agile practices and be prepared to adapt these practices as needed to ensure the development of compliant, safe, and effective products. This course builds on the concepts in AAMI TIR45:2012, Guidance on the use of agile practices in the development of medical device software.

 

Target Audience

Instruction is targeted to professionals involved in medical device software development such as those in software design and testing, quality assurance, compliance, quality systems, and product development management.

Format

A combination of situation analyses, case study exercises, and both formal and informal discussions are used throughout the program to provide maximum opportunity for the application of information.

Materials

Fee includes electronic versions of the PowerPoint presentations and case studies, relevant standards and/or technical information reports, pertinent FDA documents, and additional references.


Start Date:
Monday, September 23, 2019
End Date:
Tuesday, September 24, 2019
Time:
8:00 AM - 4:00 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


Human Factors for Medical Devices - April 2019

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This 3-day course offers participants a comprehensive overview to human factors as it relates to medical devices. It includes regulatory requirements of FDA, specifically the interpretation from the Center for Devices and Radiological Health (CDRH) Human Factors Team, as they relate to human factors, and the process of applying human factors in design controls during the design of a medical device. The course also includes the regulatory perspective of the Center for Drug Evaluation and Research (CDER) and the impact of human factors on pharma.

 

Registration Fees:

  • AAMI Members: $2235
  • Nonmembers: $2535
  • Government Employees: $950

 

Program Outline

 


DAY 1 | 8 AM-5 PM
  • Introduction and Overview 
  • Case Study 1
  • Preliminary Analysis: Uses, Users, Use Environments, and User Interfaces
  • Preliminary Analysis: Analytical Approaches to Identifying Use Related Risks
  • Preliminary Analysis: Use Related Risks Part 2, Task Analysis and PCA


DAY 2 | 8 AM-5 PM
  • Preliminary Analysis: Analytical Methods, Empirical Methods
  • Formative Exercises and Reporting
  • Root Cause Analysis 
  • Risk Elimination and Reduction Standards 
  • Rosetta Stone


DAY 3 | 8 AM-5 PM
  • FDA - CDRH and CDER
  • Validation Exercises
  • Group Presentations




 

 

Program Objective

A basic foundation for applying human factors will be set, with discussions on user models and task analysis; anatomy of use errors; and how task analysis forms the basis for planning human factors efforts. Course content will also include a review of human factors methodologies – contextual inquiry, heuristic evaluations, formative studies, and summative studies. Relevant human factors standards are discussed as well as human factors in the post-market arena. There are hands-on exercises as well as real-life case studies illustrating the application of human factors to medical devices.

 

Faculty

All course faculty have completed an instructor training program. On-going peer and participant evaluation ensure consistency and quality from course to course. The faculty team for each program includes a lead instructor and an industry expert(s).

 

Target Audience

This course is designed for quality and design engineers; research and development managers; risk managers; personnel from marketing, regulatory affairs, quality assurance, clinical/medical affairs, and customer service; and government regulators who are new to the application of human factors to medical devices. AAMI recommends this course for professionals who already have a basic understanding of the framework of quality management systems, particularly design control, risk management, and CAPA activities, but need more in-depth information about the concepts, science, processes, methodologies, and practical applications of human factors. It is recommended that human factors personnel who are new to the medical device industry have working knowledge of the Quality System regulation and design controls.

 

Format

A combination of situation analyses, case study exercises, and both formal and informal discussions are used throughout the program to provide maximum opportunity for the application of information.

 

 

Materials

Fee includes electronic versions of the PowerPoint presentations and case studies, pertinent FDA documents, and additional references.


Start Date:
Tuesday, April 30, 2019
End Date:
Thursday, May 02, 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 - $2,235.00
List Price
$950.00 - $2,535.00


Human Factors for Medical Devices - November 2019

http://my.aami.org/aamiresources/images/events/901-Glebe.jpg
This 3-day course offers participants a comprehensive overview to human factors as it relates to medical devices. It includes regulatory requirements of FDA, specifically the interpretation from the Center for Devices and Radiological Health (CDRH) Human Factors Team, as they relate to human factors, and the process of applying human factors in design controls during the design of a medical device. The course also includes the regulatory perspective of the Center for Drug Evaluation and Research (CDER) and the impact of human factors on pharma.

 

Registration Fees:

  • AAMI Members: $2235
  • Nonmembers: $2535
  • Government Employees: $950

 

Program Outline

 


DAY 1 | 8 AM-5 PM 
  • Introduction and Overview 
  • Case Study 1
  • Preliminary Analysis: Uses, Users, Use Environments, and User Interfaces
  • Preliminary Analysis: Analytical Approaches to Identifying Use Related Risks
  • Preliminary Analysis: Use Related Risks Part 2, Task Analysis and PCA


DAY 2 | 8 AM-5 PM 
  • Preliminary Analysis: Analytical Methods, Empirical Methods
  • Formative Exercises and Reporting
  • Root Cause Analysis 
  • Risk Elimination and Reduction Standards 
  • Rosetta Stone


DAY 3 | 8 AM-5 PM 
  • FDA - CDRH and CDER
  • Validation Exercises
  • Group Presentations




 

 

Program Objective

A basic foundation for applying human factors will be set, with discussions on user models and task analysis; anatomy of use errors; and how task analysis forms the basis for planning human factors efforts. Course content will also include a review of human factors methodologies – contextual inquiry, heuristic evaluations, formative studies, and summative studies. Relevant human factors standards are discussed as well as human factors in the post-market arena. There are hands-on exercises as well as real-life case studies illustrating the application of human factors to medical devices.

 

Faculty

All course faculty have completed an instructor training program. On-going peer and participant evaluation ensure consistency and quality from course to course. The faculty team for each program includes a lead instructor and an industry expert(s).

 

Target Audience

This course is designed for quality and design engineers; research and development managers; risk managers; personnel from marketing, regulatory affairs, quality assurance, clinical/medical affairs, and customer service; and government regulators who are new to the application of human factors to medical devices. AAMI recommends this course for professionals who already have a basic understanding of the framework of quality management systems, particularly design control, risk management, and CAPA activities, but need more in-depth information about the concepts, science, processes, methodologies, and practical applications of human factors. It is recommended that human factors personnel who are new to the medical device industry have working knowledge of the Quality System regulation and design controls.

 

Format

A combination of situation analyses, case study exercises, and both formal and informal discussions are used throughout the program to provide maximum opportunity for the application of information.

 

Materials

Fee includes electronic versions of the PowerPoint presentations and case studies, pertinent FDA documents, and additional references.



Start Date:
Tuesday, November 19, 2019
End Date:
Thursday, November 21, 2019
Time:
8:00 AM - 5:00 PM Eastern Standard Time
Address:
AAMI Center for Excellence (ACE)
901 North Glebe Road Suite 300
Arlington, VA 22203
UNITED STATES
AAMI Member
$950.00 - $2,235.00
List Price
$950.00 - $2,535.00


Human Factors for Medical Devices - September 2019

http://my.aami.org/aamiresources/images/events/901-Glebe.jpg
This 3-day course offers participants a comprehensive overview to human factors as it relates to medical devices. It includes regulatory requirements of FDA, specifically the interpretation from the Center for Devices and Radiological Health (CDRH) Human Factors Team, as they relate to human factors, and the process of applying human factors in design controls during the design of a medical device. The course also includes the regulatory perspective of the Center for Drug Evaluation and Research (CDER) and the impact of human factors on pharma.

Registration Fees:

  • AAMI Members: $2235
  • Nonmembers: $2535
  • Government Employees: $950

 

Program Outline

 


DAY 1 | 8 AM-5 PM
  • Introduction and Overview
  • Case Study 1
  • Preliminary Analysis: Uses, Users, Use Environments, and User Interfaces
  • Preliminary Analysis: Analytical Approaches to Identifying Use Related Risks
  • Preliminary Analysis: Use Related Risks Part 2, Task Analysis and PCA


DAY 2 | 8 AM-5 PM
  • Preliminary Analysis: Analytical Methods, Empirical Methods
  • Formative Exercises and Reporting
  • Root Cause Analysis
  • Risk Elimination and Reduction Standards
  • Rosetta Stone


DAY 3 | 8 AM-5 PM
  • FDA - CDRH and CDER
  • Validation Exercises
  • Group Presentations



 

 

Program Objective

A basic foundation for applying human factors will be set, with discussions on user models and task analysis; anatomy of use errors; and how task analysis forms the basis for planning human factors efforts. Course content will also include a review of human factors methodologies – contextual inquiry, heuristic evaluations, formative studies, and summative studies. Relevant human factors standards are discussed as well as human factors in the post-market arena. There are hands-on exercises as well as real-life case studies illustrating the application of human factors to medical devices.

 

Faculty

All course faculty have completed an instructor training program. On-going peer and participant evaluation ensure consistency and quality from course to course. The faculty team for each program includes a lead instructor and an industry expert(s).

 

Target Audience

This course is designed for quality and design engineers; research and development managers; risk managers; personnel from marketing, regulatory affairs, quality assurance, clinical/medical affairs, and customer service; and government regulators who are new to the application of human factors to medical devices. AAMI recommends this course for professionals who already have a basic understanding of the framework of quality management systems, particularly design control, risk management, and CAPA activities, but need more in-depth information about the concepts, science, processes, methodologies, and practical applications of human factors. It is recommended that human factors personnel who are new to the medical device industry have working knowledge of the Quality System regulation and design controls.

 

Format

A combination of situation analyses, case study exercises, and both formal and informal discussions are used throughout the program to provide maximum opportunity for the application of information.

 

 

Materials

Fee includes electronic versions of the PowerPoint presentations and case studies, pertinent FDA documents, and additional references.


Start Date:
Tuesday, September 10, 2019
End Date:
Thursday, September 12, 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 - $2,235.00
List Price
$950.00 - $2,535.00


Industrial Ethylene Oxide Sterilization for Medical Devices Workshop - August 2019

http://my.aami.org/aamiresources/images/events/901-Glebe.jpg

This highly interactive 3.5-day, advanced course assumes that participants are experienced in working with an established ethylene oxide sterilization process, but are now challenged with ensuring the continued effectiveness and assessing change for the product or process. The program combines classroom lecture with real-life scenarios to illustrate concepts and situational analyses that provide participants with the opportunity to apply what they learn to actual sterilization scenarios. Some of the topics to be covered are: validation and requalification; validation reports, protocols, and documentation; product adoption; troubleshooting; process changes and process equivalency; product release methods; and optimization of sterilization process.

Registration Fees:

  • AAMI Members: $2335
  • Nonmembers: $2635
  • Government Employees: $950

 

 

Program Outline

 


DAY 1 | 8 AM-5 PM
Validation and Requalification
Protocols and Reports


DAY 2 | 8 AM-5 PM
Product Release Methods 
Process Specifications
Troubleshooting

DAY 3 | 8 AM-5 PM
Ethylene Oxide Residuals
Optimization of Sterilization Process


DAY 4 | 8 AM-12 PM
Product Change
Process Changes / Equivalence



 

 

Program Objective

Upon completion of this course, participants will be able to: improve development and routine turn-around time; make changes to product, equipment, process, and sterilizer location; determine if validation or requalification is necessary; troubleshoot cycle anomalies; and optimize the ethylene oxide sterilization process.

 

Target Audience

This course is designed for professionals that have responsibility for making decisions related to the ethylene oxide sterilization process such as introduction of new/modified products, sterilization process improvements, failure investigation, requalification, and validation. AAMI recommends this course for those who are experienced in working with an established ethylene oxide sterilization process and NOT professionals that are new to ethylene oxide sterilization.

 

Format

A combination of situation analyses, case study exercises, and both formal and informal discussions are used throughout the program to provide maximum opportunity for the application of information.

 

Materials

Fee includes presentations, pertinent FDA documents, additional references, and case studies.


Start Date:
Tuesday, August 27, 2019
End Date:
Friday, August 30, 2019
Time:
8:00 AM - 12:00 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 - $2,335.00
List Price
$950.00 - $2,635.00


Industrial Sterilization for Medical Devices - May 2019

http://my.aami.org/aamiresources/images/events/901-Glebe.jpg

Industrial Sterilization for Medical Devices is a comprehensive 4 day course covering essential information on sterilization technologies and methods, sterilization standards, FDA requirements, critical factors in product design and product release decisions, and much more.

Registration Fees:
  • AAMI Members: $2535
  • Nonmembers: $2835
  • Government Employees: $1050

 

 

Program Outline

 


DAY 1 | 8 AM-5 PM
Introduction
Key Concepts/Definitions
Microbes & Sterilization
Test Method Validation
Inactivation of Microorganisms


DAY 2 | 8 AM-5 PM
Sterile Packagin
Radiation Sterilization - Introduction
Radiation Sterilization - Process
Definition and Dose Establishment
Radiation Exercises
Radiation Sterilization - Product
Definition and Routine Processing 



DAY 3 | 8 AM-5 PM
Moist Heat & Ethylene Oxide Product 
Moist Heat Sterilization
Ethylene Oxide Sterilization



DAY 4 | 8 AM-5 PM
Ethylene Oxide Sterilization
Contract Sterilizers & Laboratories
FDA Perspectives 






 

 

Program Objective

Participants will learn how to apply the principles of sterilization and address requirements during product design. Participants will also determine how to select and implement an appropriate sterilization process and how to identify the elements of a successful sterilization validation. Students will participate in the design of process validation for moist heat, ethylene oxide (EO), and radiation sterilization processes and compare and contrast sterilization cycle developments based on product bioburden and those based on combined bioburden/overkill methods.

 

Target Audience

This program is recommended for professionals relatively new to the sterilization process environment who need information to help them better understand the principles and science of sterilization. This course is designed for design and process engineers, operations managers and technicians, corporate quality assurance and regulatory compliance personnel, or others directly involved in sterilization processes and responsible for meeting industry standards and FDA requirements.

 

Format

This highly interactive program combines classroom lecture with situational analyses that provide participants with the opportunity to apply what they learn to actual sterilization scenarios. In addition, participants will work through a series of case studies illustrating problematic situations. Case studies will cover various aspects and phases of sterilization processes...from design, to cycle development, to validation, to process control, to product release.

 

 

Materials

As part of the course materials, attendees receive copies of standards on the validation and routine control for industrial moist heat sterilization, ethylene oxide sterilization, and radiation sterilization as well as standards and a technical information report on packaging for terminally sterilized devices.


Start Date:
Tuesday, May 14, 2019
End Date:
Friday, May 17, 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
$1,050.00 - $2,535.00
List Price
$1,050.00 - $2,835.00


Industrial Sterilization for Medical Devices - October 2019

http://my.aami.org/aamiresources/images/events/901-Glebe.jpg

Industrial Sterilization for Medical Devices is a comprehensive 4 day course covering essential information on sterilization technologies and methods, sterilization standards, FDA requirements, critical factors in product design and product release decisions, and much more.

Registration Fees:
  • AAMI Members: $2535
  • Nonmembers: $2835
  • Government Employees: $1050

 

 

Program Outline

 


DAY 1 | 8 AM-5 PM 
Introduction
Key Concepts/Definitions
Microbes & Sterilization
Test Method Validation
Inactivation of Microorganisms


DAY 2 | 8 AM-5 PM 
Sterile Packagin
Radiation Sterilization - Introduction
Radiation Sterilization - Process
Definition and Dose Establishment
Radiation Exercises
Radiation Sterilization - Product
Definition and Routine Processing 



DAY 3 | 8 AM-5 PM 
Moist Heat & Ethylene Oxide Product 
Moist Heat Sterilization
Ethylene Oxide Sterilization



DAY 4 | 8 AM-5 PM 
Ethylene Oxide Sterilization
Contract Sterilizers & Laboratories
FDA Perspectives 






 

 

Program Objective

Participants will learn how to apply the principles of sterilization and address requirements during product design. Participants will also determine how to select and implement an appropriate sterilization process and how to identify the elements of a successful sterilization validation. Students will participate in the design of process validation for moist heat, ethylene oxide (EO), and radiation sterilization processes and compare and contrast sterilization cycle developments based on product bioburden and those based on combined bioburden/overkill methods.

 

Target Audience

This program is recommended for professionals relatively new to the sterilization process environment who need information to help them better understand the principles and science of sterilization. This course is designed for design and process engineers, operations managers and technicians, corporate quality assurance and regulatory compliance personnel, or others directly involved in sterilization processes and responsible for meeting industry standards and FDA requirements.

 

Format

This highly interactive program combines classroom lecture with situational analyses that provide participants with the opportunity to apply what they learn to actual sterilization scenarios. In addition, participants will work through a series of case studies illustrating problematic situations. Case studies will cover various aspects and phases of sterilization processes...from design, to cycle development, to validation, to process control, to product release.

 

 

Materials

As part of the course materials, attendees receive copies of standards on the validation and routine control for industrial moist heat sterilization, ethylene oxide sterilization, and radiation sterilization as well as standards and a technical information report on packaging for terminally sterilized devices.



Start Date:
Tuesday, October 01, 2019
End Date:
Friday, October 04, 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
$1,050.00 - $2,535.00
List Price
$1,050.00 - $2,835.00