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Design Control Requirements & Industry Practice Course

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Description:

This intensive 2½ day course covers the practical application of the design control requirements of the Quality System regulation to medical devices. This course offers FDA and industry the unique opportunity to participate in a shared learning experience. Examples of design control tools, templates, and practices, in use by AAMI member 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. The content focuses 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.

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

Start Date:
Wednesday, February 14, 2018
End Date:
Friday, February 16, 2018
Time:
8:00 AM - 12:00 PM Eastern Standard Time
Address:
Westin Arlington Gateway
801 North Glebe Road
Arlington, VA 22203
USA
AAMI Member
$950.00 - $2,135.00
List Price
$950.00 - $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.

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


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, January 30, 2018
End Date:
Thursday, February 01, 2018
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
$950.00 - $2,235.00
List Price
$950.00 - $2,535.00


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:

This comprehensive 2.5 day course for medical device manufacturers presents risk management concepts used throughout the quality system as well as the lifecycle of the product, from design…to manufacturing…through post-production.

Hotel Reservation Link

Start Date:
Monday, March 12, 2018
End Date:
Wednesday, March 14, 2018
Time:
8:00 AM - 12:00 PM Eastern Daylight Time
Address:
AAMI Headquarters
4301 North Fairfax Drive Suite 301
Arlington, VA 22203
USA
AAMI Member
$950.00 - $2,235.00
List Price
$950.00 - $2,535.00


International Conference on Medical Device Standards and Regulation

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Description: AAMI's International Conference on Medical Device Standards and Regulation: During this annual event, government and industry leaders from around the world will explore developments in international standards which are key to global market access and regulatory compliance.
Start Date:
Thursday, March 22, 2018
End Date:
Friday, March 23, 2018
Address:
Crystal Gateway Marriott
1700 Jefferson Davis Highway
Arlington, VA 22202
USA
AAMI Member
$375.00 - $740.00
List Price
$375.00 - $970.00


January Interim Sterilization Meetings

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Description: The following ST groups will be meeting at AAMI's office in Arlington, VA:
January 8 & 9: WG 84 - Endoscope Reprocessing
January 10: WG 12 - Instructions for Reusable Device Reprocessing
January 11: WG 93 - Cleaning of Reusable Medical Devices

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 members of the working group meeting that day. A web/teleconference participation option will be available.
ALL attendees, whether in-person or by phone, will be REQUIRED to register for this meeting. More information will be available after registration closes.

Start Date:
Monday, January 08, 2018
End Date:
Thursday, January 11, 2018
Address:
AAMI Headquarters
4301 North Fairfax Drive, Suite 301
Arlington, VA 22203
UNITED STATES
AAMI Member
$0.00
List Price
$0.00



Regulatory Requirements for Software Validation

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Description:

This 3-day course focuses on the requirements contained in the Quality System regulation specific to software validation. The course explores the latitude and flexibility of the FDA's expectations and provides conceptual ways to meet compliance requirements. Relevant standards, FDA guidance documents, and other resources will be discussed that assist in determining compliance practices.

Hotel Reservation Link

Start Date:
Monday, March 19, 2018
End Date:
Wednesday, March 21, 2018
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
$950.00 - $2,235.00
List Price
$950.00 - $2,535.00


The Quality System 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, March 26, 2018
End Date:
Friday, March 30, 2018
Address:
Westin Arlington Gateway
801 North Glebe Road
Arlington, VA 22203
USA
AAMI Member
$1,150.00 - $2,985.00
List Price
$1,150.00 - $3,285.00


The Quality System and ANSI/AAMI/ISO 13485; Navigating Regulatory Requirements

/aamiresources/images/events/WestinArlingtonGateway.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, April 16, 2018
End Date:
Friday, April 20, 2018
Address:
Westin Arlington Gateway
801 North Glebe Road
Arlington, VA 22203
USA
AAMI Member
$1,150.00 - $2,985.00
List Price
$1,150.00 - $3,285.00


Winter Standards Week - December 4-8, 2017

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Description: Winter Standards Week will take place in Redondo Beach, CA, December 4-8, 2017. We hope to better serve our members and facilitate standards development by holding meetings that bring together ideas from different backgrounds and resources. You are invited to attend. Most meetings are open to the public and are a good way to understand the AAMI Standards program.
Start Date:
Monday, December 04, 2017
End Date:
Friday, December 08, 2017
Address:
Torrance Marriott Redondo Beach
3635 Fashion Way
Torrance, CA 90503
UNITED STATES
AAMI Member
$0.00
List Price
$0.00