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Building Your Management Toolbox—Part III: Interviewing Techniques

This exciting webinar series from AAMI is designed to help Supervisors of HTM Professionals or those on a management career path develop their supervisory and leadership skills. These courses are intended to help you improve the productivity of your staff, increase patient satisfaction scores, and raise your comfort level in your management role.

Part III of the series will cover interviewing techniques. Effective hiring requires effective preparation. This course is designed to help anyone who has interviewing responsibility to help select the best candidate for your organization.
AAMI Member:
$0.00
List Price:
$85.00
Available for Immediate Download
↑/↓ Full Details


Communications for Quality System Managers On-Demand Course

This course helps you explain the meaning and importance of communication for quality system managers, implement general tools and techniques you can use to achieve successful communication, determine how to communicate effectively with various audiences, and communicate with documentation.
AAMI Member:
$199.00
List Price:
$250.00
Available for Immediate Download
↑/↓ Full Details


Demystifying EO Calculations On-Demand Course

This self-paced course demonstrates how to calculate appropriate humidity levels for static and dynamic conditioning, determine the correct pressure level in the sterilization cycle for a specified EO concentration, calculate the D-value to determine the appropriate exposure time for a sterilization cycle, and more.
AAMI Member:
$395.00
List Price:
$525.00
Available for Immediate Download
↑/↓ Full Details


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, August 29, 2018
End Date:
Friday, August 31, 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
$950.00 - $2,135.00
List Price
$950.00 - $2,435.00


Design Control Requirements and Industry Practice

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Description: Please note Start time of 12:00 Noon.

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, September 12, 2018
End Date:
Friday, September 14, 2018
Time:
12:00 PM - 5:00 PM Eastern Daylight Time
Address:
Level 8 Meeting Rooms, Building 1
ITRI, 321 Sec 2, Kuang Fu Rd.
Hsinchu 30011
TAIWAN
AAMI Member
$950.00 - $2,135.00
List Price
$950.00 - $2,435.00


Design Control Requirements and Industry Practice

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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, September 05, 2018
End Date:
Friday, September 07, 2018
Time:
8:00 AM - 12:00 PM Eastern Daylight Time
Address:
Munich Airport Marriott Hotel
Alois Steinecker Strasse 20
85354 Freising, Germany
AAMI Member
$950.00 - $2,135.00
List Price
$950.00 - $2,435.00


Documents and Records Management for Medical Devices

This online program provides participants with the skills and tools needed for quality improvement and compliance within their organization as related to the handling of documents and records. Course content utilizes real-life scenarios with a variety of situations and case studies for analysis toward practical resolutions.
AAMI Member:
$495.00
List Price:
$625.00
Available for Immediate Download
↑/↓ Full Details


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:
Monday, October 15, 2018
End Date:
Tuesday, October 16, 2018
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
Address:
Bally's Las Vegas
3645 S Las Vegas Blvd
Las Vegas, NV 89109
UNITED STATES
AAMI Member
$950.00 - $2,135.00
List Price
$950.00 - $2,435.00


Ethylene Oxide Fundamentals On-Demand Course

EO Fundamentals provides students with an overview of ethylene oxide and the validation process used to confirm that a medical device utilizing EO methods will consistently perform to pre-determined specifications. The validation process includes written protocols, evidence that equipment installation meets design criteria and specifications, data collection, and evidence that the device reliably performs the sterilization method.
AAMI Member:
$395.00
List Price:
$525.00
Available for Immediate Download
↑/↓ Full Details


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


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.

Hotel Reservation Link



Start Date:
Monday, October 15, 2018
End Date:
Wednesday, October 17, 2018
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, June 26, 2018
End Date:
Thursday, June 28, 2018
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
Address:
Renaissance Manchester City Centre Hotel
Blackfriars Street
Manchester England UK
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.

Hotel Reservation Link



Start Date:
Monday, December 03, 2018
End Date:
Thursday, December 06, 2018
Time:
8:00 AM - 5:00 PM Eastern 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 Quality System

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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.
Start Date:
Monday, September 10, 2018
End Date:
Wednesday, September 12, 2018
Time:
8:00 AM - 12:00 PM Eastern Daylight Time
Address:
Level 8 Meeting Rooms, Building 1
ITRI, 321 Sec 2, Kuang Fu Rd.
Hsinchu 30011
TAIWAN
AAMI Member
$950.00 - $2,235.00
List Price
$950.00 - $2,535.00


Pillars of Medical Device Quality System Leadership

No matter your level of accomplishment, this course will provide direction for you to develop your pillars, such as your knowledge base, experience, communication skills, staff selection, interdepartmental support, and teamwork.
AAMI Member:
$199.00
List Price:
$250.00
Available for Immediate Download
↑/↓ Full Details


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 Link

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 Link

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 Eastern 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


Sterile Processing: Preparing for Accreditation

Every central service or sterile processing department must be prepared for on-site surveys from their facility's accrediting body. How do you prepare for the survey and ensure your department's compliance? To answer this question and offer guidance on common things surveyors look for, AAMI is pleased to offer this 90-minute eLearning program. This interactive, self-paced training is derived from an education program provided to Joint Commission surveyors and has been adapted for the AAMI audience.
AAMI Member:
$99.00
List Price:
$130.00
Available for Immediate Download
↑/↓ Full Details