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Design Control Requirements & Industry Practice Course

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Description:

2½ day intensive course focusing on the how-to's of implementing a program that meets FDA's design control requirements while ensuring a fast and efficient flow of new products. Upon completion, participants will be able to evaluate the degree of compliance of a design control system, including identification of noncompliance issues, and be prepared to implement improvements to meet regulatory and business strategies.

The course will be held at the Hilton San Diego Del Mar from 8:00 am - 5:00 pm Monday, December 4, through Tuesday, December 5, and from 8:00 am - 12:00 pm Wednesday, December 6, 2017.

Group Room Rate: Single/double rate: $149
Room rate good through November 13, 2017
Hotel Reservation Link


Start Date:
Monday, December 04, 2017
End Date:
Wednesday, December 06, 2017
Time:
8:00 AM - 12:00 PM Eastern Standard Time
Address:
Hilton San Deigo Del Mar
15575 Jimmy Durante Blvd
Del Mar, CA 92014
USA
AAMI Member
$2,135.00
List Price
$2,435.00


Design Control Requirements & Industry Practice Course

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Description:

2½ day intensive course focusing on the how-to's of implementing a program that meets FDA's design control requirements while ensuring a fast and efficient flow of new products. Upon completion, participants will be able to evaluate the degree of compliance of a design control system, including identification of noncompliance issues, and be prepared to implement improvements to meet regulatory and business strategies.

1-888-373-9855
Single/double rate: $79 Weekday/$145 Weekend
Rate through October 2, 2017
Hotel Reservation Link

Start Date:
Monday, October 30, 2017
End Date:
Wednesday, November 01, 2017
Time:
8:00 AM - 12:00 PM Eastern Daylight Time
Address:
The Flamingo Las Vegas
3555 Las Vegas Blvd South
Las Vegas, NV 89109
USA
AAMI Member
$2,135.00
List Price
$2,435.00


Developing and Validating Software Workshop

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Description:

Three day workshop provides attendees with guidance on designing software validation plans that build confidence in the software and comply with regulatory requirements. The workshop is exercise-driven to allow attendees to apply appropriate validation tools and techniques for embedded device software, off-the-shelf software, and quality system (non-device) software course. Case studies on traceability analysis, requirements writing, test designs, and validation planning give examples and possible solutions to validation activities.

Hotel Reservation Link

Start Date:
Tuesday, November 14, 2017
End Date:
Thursday, November 16, 2017
Time:
8:00 AM - 5:00 PM Eastern Standard Time
Address:
AAMI Headquarters
4301 North Fairfax Drive Suite 301
Arlington, VA 22203
USA
AAMI Member
$2,235.00
List Price
$2,535.00


Effective Application of Agile Practices in the Development of Medical Device Software

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Description:

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.

Hotel Reservation Link

Start Date:
Thursday, August 24, 2017
End Date:
Friday, August 25, 2017
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
Address:
AAMI Headquarters
4301 North Fairfax Drive Suite 301
Arlington, VA 22203
USA
AAMI Member
$2,135.00
List Price
$2,435.00


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 will be held at the Hyatt Arlington from 8:00 am - 5:00 pm on Monday, November 13, through Wednesday, November 15, 2017. Check-in for the course will begin at 7:00 am on Day One and continental breakfast will be served at 7:00 am each morning. Dress code for the course is business casual.

Group Room Rate: Single/double rate: $209
Room rate good through October 23, 2017
Hotel Reservation Link


Start Date:
Monday, November 13, 2017
End Date:
Wednesday, November 15, 2017
Time:
8:00 AM - 5:00 PM Eastern Standard Time
Address:
Hyatt Arlington
1325 Wilson Blvd
Arlington, VA 22209
USA
AAMI Member
$2,235.00
List Price
$2,535.00


Industrial Ethylene Oxide Sterilization for Medical Devices

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Description:

3 1/2 day workshop presenting intensive coverage of principles, processes, best practices, and industry standards in ethylene oxide sterilization for medical devices. Topics touched upon include validation and requalification; validation reports, protocols, and documentation; product adoption; troubleshooting; process changes and process equivalency; product release methods; and optimization of sterilization process. The workshop is for individuals who 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.

1-585-792-5200
Single/double rate: $149
Rate through August 29, 2017
Hotel Reservation Link

Start Date:
Tuesday, September 19, 2017
End Date:
Friday, September 22, 2017
Time:
8:00 AM - 12:00 PM Eastern Daylight Time
Address:
Hilton San Diego Del Mar
15575 Jimmy Durante Blvd
Del Mar, CA 92014
AAMI Member
$2,335.00
List Price
$2,635.00


Industrial Sterilization for Medical Devices Course

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Description: 4 day course covering sterilization processing in a medical device manufacturing environment. Topics addressed include sterilization technologies and methods, sterilization standards, FDA requirements, and critical factors in product design and product release decisions. Recommended for those who are relatively new to the sterilization process environment and need information to help them better understand the principles and science of industrial sterilization.

The course will be held at the Citywest Hotel Dublin from 8:00 am - 5:00 pm on Tuesday, June 6, through Thursday, June 8, 2017. Check-in for the course will begin at 7:00 am on Day One. Dress code for the course is business casual.

For further information about the hotel, transportation, and local attractions, please visit the Citywest's Website. Hotel Information


Start Date:
Monday, December 04, 2017
End Date:
Thursday, December 07, 2017
Time:
8:00 AM - 5:00 PM Eastern Standard Time
Address:
CityWest Hotel Dublin
Saggart
Co Dublin, Ireland
AAMI Member
$2,535.00
List Price
$2,835.00


Integrating Risk Management Into the Quality System Course

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Description:

2½ day course presenting risk management concepts and practices used throughout the quality system as well as the lifecycle of the product, from design, to manufacturing, through post-production. Those looking for guidance on regulatory requirements and ways that standards are related to risk management will also benefit from this program.

1-888-373-9855
Single/double rate: $79 Weekday/$145 Weekend
Rate through October 2, 2017
Hotel Reservation Link

Start Date:
Monday, October 30, 2017
End Date:
Wednesday, November 01, 2017
Time:
8:00 AM - 12:00 PM Eastern Daylight Time
Address:
The Flamingo Las Vegas
3555 Las Vegas Blvd South
Las Vegas, NV 89109
USA
AAMI Member
$2,235.00
List Price
$2,535.00


Process Validation Requirements & Industry Practice Course

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Description:

2½ day intensive course providing the knowledge and skills needed to comply with FDA's process validation requirements while offering information on how to implement an effective validation program. Upon completion of the course, participants will be able to apply the principles of process validation to their operations.

1-888-373-9855
Single/double rate: $79 Weekday/$145 Weekend
Rate through October 2, 2017
Hotel Reservation Link

Start Date:
Wednesday, October 25, 2017
End Date:
Friday, October 27, 2017
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
Address:
The Flamingo Las Vegas
3555 Las Vegas Boulevard South
Las Vegas, NV 89109
USA
AAMI Member
$2,135.00
List Price
$2,435.00


Quality System Requirements & Industry Practice Course

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Description:

4 day comprehensive course, with an optional exam which is available online for 2 weeks following the end of the program, providing the basic knowledge and skills needed to develop a quality system program that conforms with FDA's Quality System regulation. Content is based on the body of knowledge developed jointly by representatives of the medical device industry and FDA.

Hotel Reservation Link

Start Date:
Monday, September 18, 2017
End Date:
Thursday, September 21, 2017
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
Address:
AAMI Headquarters
4301 North Fairfax Drive Suite 301
Arlington, VA 22203
AAMI Member
$2,685.00
List Price
$2,985.00


Quality System Requirements & Industry Practice Course

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Description:

4 day comprehensive course, with an optional exam which is available online for 2 weeks following the end of the program, providing the basic knowledge and skills needed to develop a quality system program that conforms with FDA's Quality System regulation. Content is based on the body of knowledge developed jointly by representatives of the medical device industry and FDA.

The course will be held at the Citywest Hotel Dublin from 8:00 am - 5:00 pm on Monday, September 11, through Thursday, September 14, 2017. Check-in for the course will begin at 7:00 am on Day One. Dress code for the course is business casual.

For further information about the hotel, transportation, and local attractions, please visit the Citywest's Website. Hotel Information


Start Date:
Monday, September 11, 2017
End Date:
Thursday, September 14, 2017
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
Address:
Citywest Hotel Dublin
Saggart
CO. DUBLIN
IRELAND
AAMI Member
$2,685.00
List Price
$2,985.00


Quality System Requirements & Industry Practice Course

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Description:

4 day comprehensive course, with an optional exam which is available online for 2 weeks following the end of the program, providing the basic knowledge and skills needed to develop a quality system program that conforms with FDA's Quality System regulation. Content is based on the body of knowledge developed jointly by representatives of the medical device industry and FDA.

The course will be held at the Royal Sonesta New Orleans from 8:00 am - 5:00 pm on Monday, December 11, through Thursday, December 14, 2017. Check-in for the course will begin at 7:00 am on Day One.

Group Room Rate: Single $239/Double $259
Room rate good through November 20, 2017
Hotel Reservation Link


Start Date:
Monday, December 11, 2017
End Date:
Thursday, December 14, 2017
Time:
8:00 AM - 5:00 PM Eastern Standard Time
Address:
Royal Sonesta New Orleans
300 Bourbon Street
New Orleans, LA 70130
AAMI Member
$2,685.00
List Price
$2,985.00


Quality System Requirements & Industry Practice Course

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Description:

4 day comprehensive course, with an optional exam which is available online for 2 weeks following the end of the program, providing the basic knowledge and skills needed to develop a quality system program that conforms with FDA's Quality System regulation. Content is based on the body of knowledge developed jointly by representatives of the medical device industry and FDA.

1-888-373-9855
Single/double rate: $79 Weekday/$145 Weekend
Rate through October 2, 2017
Hotel Reservation Link

Start Date:
Tuesday, October 24, 2017
End Date:
Friday, October 27, 2017
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
Address:
The Flamingo Las Vegas
3555 Las Vegas Blvd South
Las Vegas, NV 89109
AAMI Member
$2,685.00
List Price
$2,985.00


Radiation Sterilization for Medical Devices Course

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Description:

3½ day course providing intensive coverage of principles, processes, best practices, and industry standards in radiation sterilization for medical devices. Topics covered include the scientific theory and principles of radiation sterilization; FDA expectations regarding successful submissions and inspections, recalls, problem solving, and risk avoidance; and review of the 11137 series radiation sterilization standards.

Hotel Reservation Link

Start Date:
Tuesday, October 10, 2017
End Date:
Friday, October 13, 2017
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
Address:
AAMI Headquarters
4301 North Fairfax Drive Suite 301
Arlington, VA 22203
AAMI Member
$2,335.00
List Price
$2,635.00


The Application of Agile to the Development of Medical Device Systems

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Description:

For many years software development teams have been using Agile Software Development methods, but Agile is not just for software. Agile's Lean Product Development principles also apply to the development of hardware-based products and systems. This new, two-day course goes beyond small-team and software-only applications and demonstrates how Agile practices can be used in the development of medical device systems.

Building on the concepts of the Effective Application of Agile Practices in the Development of Medical Device Software, this course will explore ways to apply Agile methods in the context of developing a medical device system that includes more than software. We will discuss specific ways to integrate Agile Methods and Systems Engineering techniques.

Hotel Reservation Link

Start Date:
Tuesday, October 17, 2017
End Date:
Wednesday, October 18, 2017
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
Address:
AAMI Headquarters
4301 North Fairfax Drive Suite 301
Arlington, VA 22203
USA
AAMI Member
$2,135.00
List Price
$2,435.00