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AAMI Biological Evaluation Committee (BE) and Working Groups

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Description: AAMI Biological Evaluation Committee (BE) and Working Groups, will be meeting at AAMI's office in Arlington, VA on Thursday, August 30, 2018.

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

Due to space limitations, in-person attendance will be limited to Primary or Alternate members of the committee or working groups. 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.

Date:
Thursday, August 30, 2018
Address:
AAMI Headquarters
4301 North Fairfax Drive, Suite 301
Arlington, VA 22203
UNITED STATES
AAMI Member
$0.00
List Price
$0.00


AAMI/CN/WG 01, Luer Activated Valves Meeting

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Description: AAMI/CN/WG01, Luer activated valves, will be meeting in Torino, Italy, December 3-5, 2018.

Please register for the meeting below. Registration is necessary to ensure proper accommodations.
You must log in or create a profile in order to register.

Although registration is free, you will need to click the "Pay Now" and "Place Order" buttons to complete the process. You will not be prompted to enter payment.
Please note: you will receive an emailed receipt of your registration. If you don't get this receipt, please contact AAMI Standards.

If you have questions about this meeting, please contact
Colleen Elliott.

Start Date:
Monday, December 03, 2018
End Date:
Wednesday, December 05, 2018
Address:
Industrie BORLA S.P.A.
Via G. di Vittorio, 7 Bis
10024 Moncalieri
TORINO
ITALY
AAMI Member
$0.00
List Price
$0.00


Design Control-Integrating The Quality System Regulation and ANSI/AAMI/ISO 13485 Requirements

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Description:

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.

Start Date:
Monday, December 10, 2018
End Date:
Wednesday, December 12, 2018
Time:
8:00 AM - 5:00 PM Eastern Standard Time
Address:
AAMI Training Center
901 North Glebe Road
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

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Description:

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.

Start Date:
Wednesday, September 05, 2018
End Date:
Friday, September 07, 2018
Time:
8:00 AM - 5:00 PM Central European Daylight Time
Address:
Munich Airport Marriott Hotel
Alois Steinecker Strasse 20
85354 Freising, Germany
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

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Description:

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.

Start Date:
Wednesday, August 29, 2018
End Date:
Friday, August 31, 2018
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
Address:
Westin Arlington Gateway
801 North Glebe Road
Arlington, VA 22203
UNITED STATES
AAMI Member
$950.00 - $2,235.00
List Price
$950.00 - $2,535.00



Ethylene Oxide Sterilization for Medical Devices Course

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Description:

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.

Hotel Reservation Link



Start Date:
Tuesday, August 28, 2018
End Date:
Friday, August 31, 2018
Time:
8:00 AM - 12:00 PM Eastern Daylight Time
Address:
Westin Arlington Gateway
801 North Glebe Rado
Arlington, VA 22203
UNITED STATES
AAMI Member
$950.00 - $2,335.00
List Price
$950.00 - $2,635.00


Fall Sterilization Standards Week - October 22-25, 2018

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Description: Fall Sterilization Standards Week will take place in Baltimore, MD, October 22-25, 2018.


REGISTRATION IS STRONGLY ENCOURAGED.
Some working group meetings will have critical space challenges. Seating in the meeting rooms will be allocated first to current Primary and Alternate working group members who have pre-registered and are present at meeting start time.

If you do not receive a copy of your registration receipt via email, please contact AAMI Standards. We are available if you need more information or have questions.

Start Date:
Monday, October 22, 2018
End Date:
Thursday, October 25, 2018
Address:
Hyatt Regency - Baltimore Inner Harbor
300 Light St
Baltimore, MD 21202
UNITED STATES
AAMI Member
$0.00
List Price
$0.00


Human Factors for Medical Devices

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Description:

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.


Start Date:
Monday, October 15, 2018
End Date:
Wednesday, October 17, 2018
Time:
8:00 AM - 5:00 PM W. Europe Daylight Time
Address:
Royal Marine Hotel Dublin
Marine Rd
DUN LAOGHAIRE, DUBLIN
IRELAND
AAMI Member
$950.00 - $2,235.00
List Price
$950.00 - $2,235.00


Human Factors for Medical Devices Course

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Description:

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.

Hotel Reservation Link



Start Date:
Tuesday, November 06, 2018
End Date:
Thursday, November 08, 2018
Time:
8:00 AM - 5:00 PM Eastern Standard Time
Address:
Hilton Arlington
950 North Stafford Street
Arlington, VA 22203
UNITED STATES
AAMI Member
$950.00 - $2,235.00
List Price
$950.00 - $2,535.00


Human Factors for Medical Devices Course

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Description:

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.

Hotel Reservation Link



Start Date:
Monday, September 17, 2018
End Date:
Wednesday, September 19, 2018
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
Address:
Westin Arlington Gateway
801 North Glebe Rado
Arlington, VA 22203
UNITED STATES
AAMI Member
$950.00 - $2,235.00
List Price
$950.00 - $2,535.00


Industrial Sterilization for Medical Devices

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Description: 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.

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.

Start Date:
Monday, December 03, 2018
End Date:
Thursday, December 06, 2018
Time:
8:00 AM - 5:00 PM GMT Standard Time
Address:
Renaissance Manchester City Centre Hotel
Blackfriars Street
Manchester England
UNITED KINGDOM
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

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Description: 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. The course also shows linkages between the product risk management process and quality system processes. During the course, students 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.
Start Date:
Wednesday, November 07, 2018
End Date:
Friday, November 09, 2018
Time:
8:00 AM - 5:00 PM Eastern Standard Time
Address:
Hilton Arlington
950 North Stafford Street
Arlington, VA 22203
UNITED STATES
AAMI Member
$950.00 - $2,335.00
List Price
$950.00 - $2,635.00


Process Validation Requirements and Industry Practice

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Description:

This 2.5-day course provides attendees with practical tools and techniques for process validation requirements for FDA's Quality System regulation and recognized Process Validation Guidance from the Global Harmonization Task Force. The program includes industry best practices and real-life process validation examples.

Demonstrate Return on Investment (ROI) to employers by completing and passing the Process Validation Post-Course Test. This optional, one-hour, self-assessment tests your mastery of the course materials and your ability to correctly interpret the Quality System regulation. This optional post-test which is available online for 2 weeks following the end of the program, will be available to all participants.

Hotel Reservation Information


Start Date:
Wednesday, October 24, 2018
End Date:
Friday, October 26, 2018
Time:
8:00 AM - 12:00 PM Eastern Daylight Time
Address:
AAMI Headquarters
4301 North Fairfax Drive Suite 301
Arlington, VA 22203
UNITED STATES
AAMI Member
$2,135.00
List Price
$2,435.00


Radiation Sterilization for Medical Devices

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Description:

This 3.5-day program covers principles, processes, industry best practices, and industry standards in radiation sterilization for medical devices. Some of the topics covered are: FDA expectations regarding successful submissions and inspections, recalls, problem solving, and risk avoidance; scientific theory and principles of radiation sterilization; and the 11137 series radiation sterilization standards.

Hotel Reservation Information


Start Date:
Tuesday, October 16, 2018
End Date:
Friday, October 19, 2018
Time:
8:00 AM - 12:00 PM Eastern Daylight Time
Address:
AAMI Headquarters
4301 North Fairfax Drive Suite 301
Arlington, VA 22203
UNITED STATES
AAMI Member
$950.00 - $2,335.00
List Price
$950.00 - $2,635.00


Software Validation Workshop: Practical Tools & Techniques

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Description:

This 3 day course supplies attendees with practical tools and techniques for software validation for embedded device software, Off-The-Shelf software, and Quality System (Non-Device) software. It includes real life software validation examples utilizing Engineering & Software Quality "best practices." The workshop includes practical information on a variety of topics such as writing useful & testable requirements, techniques for testing, and streamlining quality processes for development and validation efforts.Hotel Reservation Link



Start Date:
Wednesday, October 17, 2018
End Date:
Friday, October 19, 2018
Time:
8:00 AM - 5:00 PM Pacific Daylight Time
Address:
Bally's Las Vegas
3645 S Las Vegas Blvd
Las Vegas, NV 89109
UNITED STATES
AAMI Member
$950.00 - $2,235.00
List Price
$950.00 - $2,535.00



The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements

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Description: The regulatory world for quality management systems (QMS) is changing fast. To succeed in today's global market, the manufacturers of medical devices must understand those requirements. This intensive 4 ½ day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA's Quality System Regulation (21 CFR 820) and International Organization for Standardization 13485:2016, the international standard that spells out the requirements for regulatory purposes for quality management systems. 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, industry consultants and members of ISO standard development teams for standards such as 13485 and ANSI/AAMI/ISO 14971:2007(R)2016, Medical devices Application of Risk Management to Medical Devices.
Start Date:
Monday, September 24, 2018
End Date:
Friday, September 28, 2018
Time:
8:00 AM - 12:00 PM Eastern Daylight Time
Address:
Westin Arlington Gateway
801 North Glebe Road
Arlington, VA 22203
UNITED STATES
AAMI Member
$1,150.00 - $2,985.00
List Price
$1,150.00 - $3,285.00


The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements

/aamiresources/images/events/901-Glebe.jpg
Description: The regulatory world for quality management systems (QMS) is changing fast. To succeed in today's global market, the manufacturers of medical devices must understand those requirements. This intensive 4 ½ day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA's Quality System Regulation (21 CFR 820) and International Organization for Standardization 13485:2016, the international standard that spells out the requirements for regulatory purposes for quality management systems. 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, industry consultants and members of ISO standard development teams for standards such as 13485 and ANSI/AAMI/ISO 14971:2007(R)2016, Medical devices Application of Risk Management to Medical Devices.
Start Date:
Monday, December 10, 2018
End Date:
Friday, December 14, 2018
Time:
8:00 AM - 12:00 PM Eastern Standard Time
Address:
AAMI Training Center
901 North Glebe Road
Arlington, VA 22203
UNITED STATES
AAMI Member
$1,150.00 - $2,985.00
List Price
$1,150.00 - $3,285.00


The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements

/aamiresources/images/events/Hilton-Arlington.jpg
Description: The regulatory world for quality management systems (QMS) is changing fast. To succeed in today's global market, the manufacturers of medical devices must understand those requirements. This intensive 4 ½ day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA's Quality System Regulation (21 CFR 820) and International Organization for Standardization 13485:2016, the international standard that spells out the requirements for regulatory purposes for quality management systems. 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, industry consultants and members of ISO standard development teams for standards such as 13485 and ANSI/AAMI/ISO 14971:2007(R)2016, Medical devices Application of Risk Management to Medical Devices.
Start Date:
Monday, October 29, 2018
End Date:
Friday, November 02, 2018
Address:
Hilton Arlington
950 Stafford St
Arlington, VA 22203
UNITED STATES
AAMI Member
$1,150.00 - $2,985.00
List Price
$1,150.00 - $3,285.00