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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 Exchange 2019

http://my.aami.org/aamiresources/images/events/AAMI_Exchange_Logo_Color_500px.jpg
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 ID - Infusion Devices Working Group Meeting

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AAMI ID - Infusion Devices Working Group, will be meeting at the new AAMI Center of Excellence in Arlington, VA on January 29-31, 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.
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 of Excellence
901 North Glebe Road, Suite 300
Arlington, VA 22203

Click here for a list of local hotels


Start Date:
Tuesday, January 29, 2019
End Date:
Thursday, January 31, 2019
Address:
901 North Glebe Road
Suite 300
Arlington, VA 22203
UNITED STATES
AAMI Member
$0.00
List Price
$0.00


AAMI SP - Sphygmomanometer Working Group Meeting

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AAMI SP - Sphygmomanometer Working Group, will be meeting at the new AAMI Center of Excellence in Arlington, VA on January 7, 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.
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 of Excellence
901 North Glebe Road, Suite 300
Arlington, VA 22203

Click here for a list of local hotels


Date:
Monday, January 07, 2019
Time:
10:00 AM - 4:00 PM Eastern Standard Time
Address:
901 North Glebe Road
Suite 300
Arlington, VA 22203
UNITED STATES
AAMI Member
$0.00
List Price
$0.00


AAMI ST/WG 84 Interim Meeting, January 2019

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AAMI ST/WG 84, Endoscope Reprocessing, will be meeting at the new AAMI Center of Excellence in Arlington, VA on January 8, 2019.

Please register by January 2, 2019, below. Registration is necessary to ensure proper accommodations. Registration will close on January 3, 2019.


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.
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 of Excellence
901 North Glebe Road, Suite 300
Arlington, VA 22203

Click here for a list of local hotels

Date:
Tuesday, January 08, 2019
Time:
8:00 AM - 5:00 PM Eastern Standard Time
Address:
901 North Glebe Road
Suite 300
Arlington, VA 22203
UNITED STATES
AAMI Member
$0.00
List Price
$0.00


AEM Training

http://my.aami.org/aamiresources/images/events/Indianapolis.jpg

AAMI to Host AEM Training in Indianapolis

AAMI will host a special one-day forum in January for HTM professionals about AEM programs as a cost-cutting and quality improvement strategy.

The forum, which will be held in conjunction with the Indiana Biomedical Society meeting and feature leading AEM experts, will be held on Friday, Jan. 25 at the Sheraton Indianapolis City Centre.

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 Directors, Clinical Engineers, BMETs, directors of quality, IT, and facility engineering and safety.

The training is available to AAMI and IBS members for $395; and for non-members for $455.


Date:
Friday, January 25, 2019
Time:
8:00 AM - 3:00 PM Eastern Standard Time
Address:
Sheraton Indianapolis City Centre
31 W Ohio St
Indianapolis, IN 46204
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 Excellance (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 - 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 Excellance (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 Excellance (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-Integrating The Quality System Regulation and ANSI/AAMI/ISO 13485 Requirements - January 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:
Wednesday, January 30, 2019
End Date:
Friday, February 01, 2019
Time:
8:00 AM - 5:00 PM Eastern Standard Time
Address:
AAMI Center for Excellance (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 Excellance (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


Ethylene Oxide Sterilization for Medical Devices - Aug 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 Excellance (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


Human Factors for Medical Devices - April 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, April 30, 2019
End Date:
Thursday, May 02, 2019
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
Address:
AAMI Center for Excellance (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 - January 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:
Wednesday, January 23, 2019
End Date:
Friday, January 25, 2019
Time:
8:00 AM - 5:00 PM Eastern Standard Time
Address:
AAMI Center for Excellance (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 Excellance (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 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 Excellance (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


Integrating Risk Management into the Product Lifecycle: Quality and 13485 - August 2019

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

This comprehensive 3-day course for medical device manufacturers presents risk management concepts used throughout the quality system that can help your organization meet FDA and ANSI/AAMI/ISO 13485:2016 requirements for risk management. This course covers the use of risk management principles throughout the lifecycle of the product, from design…to manufacturing…through post-production to retirement. Instructors will illustrate linkages between the product risk management process and quality system processes.Students will discover how to use regulatory databases to support risk management activities at different stages of the product lifecycle, as well as the use of International Product Safety Standards during risk management activities.

Registration Fees:

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

 

 

Program Outline

 


DAY 1 | 8 AM-5 PM 

Introduction to ISO 14971

Basic Terms and Concepts

Risk Management requirements

Management Responsibilities

Risk Management at CDRH



DAY 2 | 8 AM-5 PM 

Risk Management in Product realization

· Design Controls

· Risk Management and Usability

· Production and Service provision

· Control of Monitoring and Measuring equipment

Special requirements for Software Risk Management



DAY 3 | 8 AM-5 PM 
Overall Residual Risk

 

Production and Post-Production Information including Medical MDR and IVDR requirements

Managing the risk management file

 

Risk Management in quality systems than Product realization









 

 

Program Objective

FDA and AAMI faculty work together to help the learner understand:

 

· Basic terms of risk management and how they relate to each other and how to use risk management throughout the quality system to make risk-based decisions for product realization cradle to grave

· How to use a variety of risk management tools to support risk-based thinking and decision making along with typical scenarios when the tools can be most useful,

· FDA's expectations for submissions and compliance, as well as how to apply risk management principles to various aspects of a quality system as required by the FDA and ISO 13485:2016,

· The current state of risk management based on ISO 14971 and other applicable product safety standards including those related to processes and those related to specific medical device products.

 

· How risk management is audited during MDSAP audits and how that relates to country specific requirements for risk management activities or risk-based decisions.

 

Target Audience

Instruction is targeted to quality assurance and regulatory affairs personnel, design and process engineers, manufacturing and operations managers, and members of research and development or new product development teams. For participants to gain the maximum benefit from this course, it is recommended for those who have a working knowledge of the Quality System regulation and design controls or who have already attended AAMI's Quality System and Design Control courses.

 

Format

Learning objectives are delivered in a highly interactive format includes relevant examples from a broad product spectrum that demonstrate current industry practices of risk management throughout the quality system and product lifecycle. In addition, interactive, hands on exercises will allow participants to practice applying risk management concepts, principles, and tools throughout the product lifecycle and the quality system.

 

Materials

Fee includes a comprehensive eNotebook of all training materials and many of the referenced materials, including FDA and Global Harmonization Task Force, and IMDR guidance documents relevant to the course, all in one easy to find and download location. Also provided is ANSI/AAMI/ISO 14971:2007/(R) 2010, Medical devices - Application of risk management to medical devices



Start Date:
Tuesday, August 27, 2019
End Date:
Thursday, August 29, 2019
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
Address:
AAMI Center for Excellance (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


Integrating Risk Management into the Product Lifecycle: Quality and 13485 - March 2019

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

This comprehensive 3-day course for medical device manufacturers presents risk management concepts used throughout the quality system that can help your organization meet FDA and ANSI/AAMI/ISO 13485:2016 requirements for risk management. This course covers the use of risk management principles throughout the lifecycle of the product, from design…to manufacturing…through post-production to retirement. Instructors will illustrate linkages between the product risk management process and quality system processes.Students will discover how to use regulatory databases to support risk management activities at different stages of the product lifecycle, as well as the use of International Product Safety Standards during risk management activities.

Registration Fees:

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

 

 

Program Outline

 


DAY 1 | 8 AM-5 PM

Introduction to ISO 14971

Basic Terms and Concepts

Risk Management requirements

Management Responsibilities

Risk Management at CDRH



DAY 2 | 8 AM-5 PM

Risk Management in Product realization

· Design Controls

· Risk Management and Usability

· Production and Service provision

· Control of Monitoring and Measuring equipment

Special requirements for Software Risk Management



DAY 3 | 8 AM-5 PM
Overall Residual Risk

 

Production and Post-Production Information including Medical MDR and IVDR requirements

Managing the risk management file

Risk Management in quality systems than Product realization









 

 

Program Objective

FDA and AAMI faculty work together to help the learner understand:

 

· Basic terms of risk management and how they relate to each other and how to use risk management throughout the quality system to make risk-based decisions for product realization cradle to grave

· How to use a variety of risk management tools to support risk-based thinking and decision making along with typical scenarios when the tools can be most useful,

· FDA's expectations for submissions and compliance, as well as how to apply risk management principles to various aspects of a quality system as required by the FDA and ISO 13485:2016,

· The current state of risk management based on ISO 14971 and other applicable product safety standards including those related to processes and those related to specific medical device products.

· How risk management is audited during MDSAP audits and how that relates to country specific requirements for risk management activities or risk-based decisions.

 

Target Audience

Instruction is targeted to quality assurance and regulatory affairs personnel, design and process engineers, manufacturing and operations managers, and members of research and development or new product development teams. For participants to gain the maximum benefit from this course, it is recommended for those who have a working knowledge of the Quality System regulation and design controls or who have already attended AAMI's Quality System and Design Control courses.

 

Format

Learning objectives are delivered in a highly interactive format includes relevant examples from a broad product spectrum that demonstrate current industry practices of risk management throughout the quality system and product lifecycle. In addition, interactive, hands on exercises will allow participants to practice applying risk management concepts, principles, and tools throughout the product lifecycle and the quality system.

 

Materials

Fee includes a comprehensive eNotebook of all training materials and many of the referenced materials, including FDA and Global Harmonization Task Force, and IMDR guidance documents relevant to the course, all in one easy to find and download location. Also provided is ANSI/AAMI/ISO 14971:2007/(R) 2010, Medical devices - Application of risk management to medical devices


Start Date:
Tuesday, March 12, 2019
End Date:
Thursday, March 14, 2019
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
Address:
AAMI Center for Excellance (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


Process Validation for Medical Devices: Requirements and Standards - April 2019

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

This 3 -day course provides attendees with practical tools and techniques for process validation requirements for FDA’s Quality System regulation, the ISO 13485:2016 Standard and recognized Process Validation Guidance from the Global Harmonization Task Force. The program includes industry best practices and real-life process validation examples.

Registration Fees:

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

 

 

Program Outline

 


DAY 1 | 8 AM-5 PM
Establishing Process Validation Procedures
Master Validation Planning
Installation Qualification
Characterization & Study Design


DAY 2 | 8 AM-5 PM
Operational Qualification
Performance Qualification
Execution of Validation


DAY 3 | 8 AM-5 PM
Monitoring & Control 
Revalidation
Advanced Planning & Validation Strategies 






 

Program Objective

FDA and AAMI faculty work together to help the learner to:

· Determine which processes require validation and develop a Validation Master Plan

· Develop protocol content to ensure a successful validation

· Document the results and the resolution of deviations that occur during validation execution

· Plan for effectively monitors and controls for their validated processes

· Determine the revalidation requirements for product and process changes

· Planning, Protocol Development, Validation Execution, Monitoring & Control and Revalidation to meet the FDA’s expectation and industry’s best practices

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 and ISO 13485 Standard.

 

Target Audience

Instruction is geared to professionals involved with process validation in the medical device industry such as Manufacturing Leads, R&D Team Members, Quality Engineers, Quality Assurance Managers, Design Engineers, Project/Program Managers, and Manufacturing/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 3-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, a comprehensive eNotebook of all training materials and many of the referenced materials and case studies, pertinent FDA documents, 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 Excellance (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