EMB Technical and Professional Development Seminar

#EMB #FDA #IEEE-USA #medical #devices #sunlamps #laser
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Hello!  You are cordially invited to the Baltimore Section EMB Chapter meeting.  IEEE Members, Students and Guests are welcome! 

Attendance to the meeting requires Registration (no fee).  Thank you for registering! 

The National Electronics Museum website, http://www.nationalelectronicsmuseum.org

 


THIS EVENT HAS BEEN CANCELED DUE TO THE WEATHER.

 

 

The IEEE EMB Chapter of the Baltimore Section, co-hosted with EMB Chapters from Washington and Northern Virginia Sections, are hosting a technical and professional development seminar featuring two speakers. The first topic will be a general discussion regarding compliance to FDA regulatory requirements for medical devices and radiation emitting products. A case study approach will illustrate the consequences of non-compliance to medical device as well as radiation-emitting product regulations. On the professional development topic, a speaker from IEEE-USA staff will discuss forms of communication, "when to text, call, email, write or pop-in" pertinent to your work and workplace environment.



  Date and Time

  Location

  Hosts

  Registration



  • Date: 17 Dec 2016
  • Time: 10:30 AM to 01:30 PM
  • All times are (UTC-05:00) Eastern Time (US & Canada)
  • Add_To_Calendar_icon Add Event to Calendar
  • 1745 W Nursery Rd
  • Linthicum Heights, Maryland
  • United States 21090
  • Building: National Electronics Museum (NEM)
  • Room Number: Pioneer Hall
  • Click here for Map

  • Contact Event Host
  • Questions about the meeting, c.carey@ieee.org

    Questions about first topic, Karosmanuel@aol.com

    Questions about second topic, c.mcmanes@ieee.org

    Questions about the museum, nemuseum@gmail.com

  • Co-sponsored by National Electronics Museum
  • Starts 07 November 2016 12:00 AM
  • Ends 12 December 2016 12:00 AM
  • All times are (UTC-05:00) Eastern Time (US & Canada)
  • No Admission Charge


  Speakers

Manny Karos of Allied Quality Services LLC

Topic:

"Perspectives and Case Experiences from a former U.S. FDA Medical Device Compliance Officer"

The talk will focus on FDA injunctions and seizure recommendations under medical device and electronic product radiation control laws. Speaker, a former FDA Compliance Officer will share his experience with sunlamps and laser industrial products manufacturers.

Biography:

Education: B.S. Technology and Management, University of Maryland M.S. Systems Management, University of Southern California, Safety and Research and Development.

Achievements: Graduated from the Federal Executive Management Program in 1993. Served as Acting Branch Chief in the Division of Federal State Relations and Epidemiology and Recall Branch of the Division of Emergency Operations in Office of Regional Operations and Acting Section Chief in the Light Products Section of the Office of Compliance. Served as Assistant Professor on the Adjunct Faculty of the University of Maryland from 1982 to 1998

Professional Experience:

2007 to 2016, President, Allied Quality Services LLC Regulatory Consultant- Providing the sunlamp industry with medical device expertise regarding compliance to FDA laws, regulations and policies.

1985 to 2007, FDA/CDRH Office of Compliance & Office of Communications Education and Radiation Programs. Consumer Safety Officer - Responsible for enforcement of product performance standards including industrial laser products, medical laser products, laser light show products, fiber optic laser communication systems, sunlamp products and ultraviolet lamps and mercury vapor lamp products.

1976 to 1985 US Consumer Product Safety Commission- Engineering Technologist

1970-1975 General Testing Laboratory Essex Corporation Engineering Technician

Email:

Address:Rockville, United States

Chris McManes (mick-maynz) Chris McManes (mick-maynz) of IEEE-USA

Topic:

"When to Text, Call, Email, Write or Pop In"

We have so many means of communicating with one another in the workplace nowadays. What’s best in one situation might not be best for another. In this presentation, Chris will examine the major forms of workplace communication and review the pros and cons of each.

Biography:

Chris McManes (Mick-MAYNZ), IEEE-USA public relations manager, handles media relations and contributes to podcasting and social media. He has traveled around the world representing IEEE-USA and encouraging technology professionals to become better communicators.

McManes is an award-winning sports writer who, as sports information director at Catholic University, promoted the men’s basketball team when it won the 2001 NCAA Division III National Championship. He coaches baseball and basketball at St. Jerome Parish in Hyattsville, Md., and is an assistant baseball coach at DeMatha Catholic High School. He lives in Hyattsville with his wife and three children.

Email:

Address:Washington, D.C., United States






Agenda

10:30 Sign-in, Registration, Social

11:00 Welcome and Introduction - Carole Carey, EMB Chapter Chair

 "Brief introduction of the U.S. Medical Device Regulatory Framework", Carole Carey, C3-Carey Consultants, LLC

11:15 Technical and Regulatory Topic: Manny Karos, Regulatory Consultant, Allied Quality Services, LLC

"Perspectives and Case Experiences from a former U.S. FDA Medical Device Compliance Officer"

 

12:00 Networking Lunch and Social with complimentary light lunch and refreshments (Note: If you require special food or have food allergies, please bring your own food). 

12:30 Professional Development Topic: Chris McManes, IEEE-USA Public Relations Manager

"When to Text, Call, Email, Write or Pop In"

1:15 Closing Remarks



We welcome your ideas, suggestions for topics, speakers, site visits, set up website, health related projects for K-12, or other novel activites or collaborations for 2017. Please contact Chapter Chair to volunteer. Become more involved as an EMB Chapter officer.  Let's chat! c.carey@ieee.org.

Thank you! Carole