Yearly Archives: 2019

/2019

AAMI/CQT Solutions Design Control Requirements – Integrating The Quality System Regulation and ANSI AAMI ISO 13485 – Ireland – September 30 – October 2

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. For registration info:  https://my.aami.org/store/events/registration.aspx?event=DCIH093019

2019-09-25T17:31:20+00:00September 25th, 2019|

Application of Agile to the Development of Medical Device Systems – September 25-27, 2019

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 two and a half day course goes beyond small-team and software-only applications and demonstrates how Agile practices can be [...]

2019-09-17T19:43:11+00:00September 17th, 2019|

Design Control Requirements – Integrating the Quality System Regulation and ANSI/AAMI/ISO 13485 – September 24-26, 2019

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. For more info and registration:  https://my.aami.org/store/events/registration.aspx?event=DC0919

2019-09-17T19:44:37+00:00September 17th, 2019|

Effective Application of Agile Practices in the Development of Medical Device Software – September 23-24, 2019

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. For more info and registration:  https://my.aami.org/store/events/registration.aspx?event=AP0919

2019-09-17T19:33:24+00:00September 17th, 2019|

Manufacturing Leadership Development Series – Module 4: Team Work and Team Building – September 24, 2019 – 9 am to 12 noon ET

Teams are typically comprised of people with diverse ideas and backgrounds and will always outperform individuals when leaders understand how to build these teams and leverage the strengths of all team members. This module defines types of teams and the typical roles and responsibilities associated with each and discovers problem solving as a team. For [...]

2019-09-16T19:34:07+00:00September 16th, 2019|

Manufacturing Leadership Development Series – Module 3: Coaching and Mentoring – September 17, 2019 – 9 am to 12 noon ET

Coaching and mentoring comes in multiple forms and both are critical to the success of strengthening your team and building a solid succession plan for key leaders. This module defines and explains how to coach and mentor, how to set appropriate goals and coaching to achieve those goals, how to overcome common obstacles and develop [...]

2019-09-11T18:47:24+00:00September 11th, 2019|

The Quality System Regulation 21 CFR 280 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements – September 2019

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 [...]

2019-09-11T18:20:27+00:00September 11th, 2019|

Workforce Development Conference 2019 – September 18

Leaders of business and industry, local chambers, workforce and economic development agencies, and Tennessee’s higher education community are all hard at work to constantly strengthen our state’s workforce preparedness and close skills gaps. We hope you will join us to learn and share your thoughts/opinions on the future direction of education and workforce policies and [...]

2019-09-11T18:12:37+00:00September 11th, 2019|

Manufacturing Leadership Development Series – Module 2: Goal Setting and Execution – September 10, 2019 – 9 am to 12 noon ET

Today’s leader must be versatile and adaptable. This training is designed for department heads, front line supervisors, team leaders and coordinators whether they are new to the position or have been in a leadership role for years. The seven (3hr/class) module course can be delivered according to your business needs. For more info:  http://tnchamber.chambermaster.com/events/details/mfg-leadership-development-series-knoxville-module-2-2458  

2019-09-05T18:36:48+00:00September 5th, 2019|