Goode Compliance International

Goode Compliance International Specializing in Quality Compliance Services, GCI provides innovative engineering services and solutions to medical device manufacturers.

Goode Compliance International, has provided expert ex*****on of regulatory, compliance, validation, custom in-plant training, and project resourcing since 2002. Our work has a proven track record with the FDA and with our customers. Our biomedical engineers have been trained and vetted to the most recent technologies, quality systems practices and regulations, and are well-prepared to address you

r quality systems, process validation and documentation gaps. GCI’s award-winning instructors customize your quality training experience to your exact specifications. Compliance is measurably enhanced when your staff receives clear instruction from our highly-skilled trainers, and we verify the effectiveness of the training with well-designed assessments. Technical documentation remediation and ex*****on services are our compliance specialties. We have helped numerous companies resolve 483 observations, Warning Letter findings, and MDD Audit observations, and we provide proactive correction services to prevent regulatory actions from occurring in the first place.

12/21/2016
Last week, GCIers came together and assembled care packages to send to deployed soldiers worldwide. We brought in four b...
12/15/2016

Last week, GCIers came together and assembled care packages to send to deployed soldiers worldwide. We brought in four big boxes of supplies and wrote letters thanking the soldiers for protecting us, especially during the holiday season, when it is even more difficult to be away from family and friends. We hope our gifts will bring some “Goode Vibes” to the troops, since we would not be able to have any without their dedicated service.

GCI would like to wish you a wonderful Thanksgiving filled with joy and delicious food!
11/24/2016

GCI would like to wish you a wonderful Thanksgiving filled with joy and delicious food!

GCIers come together across the country to celebrate the holidays! Check out this photo of our team members in Minnesota...
11/22/2016

GCIers come together across the country to celebrate the holidays! Check out this photo of our team members in Minnesota sharing a Thanksgiving meal.

Another GCI holiday celebration bites the dust! We are all grateful to work amongst such a wonderful group of people tha...
11/22/2016

Another GCI holiday celebration bites the dust! We are all grateful to work amongst such a wonderful group of people that make GCI’s office like our second home.

11/21/2016
11/03/2016
We had such a great time at IVT's 22nd Annual Validation Week that we were sad to see it go by so quickly. Thank you to ...
10/21/2016

We had such a great time at IVT's 22nd Annual Validation Week that we were sad to see it go by so quickly. Thank you to everyone who attended our SME presentations. Already looking forward to next year!

Please help us congratulate GCI president, Roberta Goode, for being selected as IVT’s Speaker of the Year for the second...
10/20/2016

Please help us congratulate GCI president, Roberta Goode, for being selected as IVT’s Speaker of the Year for the second year in a row! Thank you to John Kirchner and IVT Network for choosing our President out of 200 other thought leaders and 400 total talks. It's a great day to be a GCIer!

There's still time to join us for our free webinar at 1 PM EST on Risk Management and ISO 14971! Register now for access...
08/24/2016

There's still time to join us for our free webinar at 1 PM EST on Risk Management and ISO 14971! Register now for access: goo.gl/Lux370

This week we had to say goodbye to our amazing marketing intern, Erin, as she continues her studies at Villanova Univers...
08/19/2016

This week we had to say goodbye to our amazing marketing intern, Erin, as she continues her studies at Villanova University. She was such a great addition to the team! Are you looking for a new and exciting career? Check out our open positions here at GCI: https://goo.gl/7FFnaN

Meet Project Lead Will Brown. Read the full interview with Will here: goo.gl/ioFESe.
08/17/2016

Meet Project Lead Will Brown. Read the full interview with Will here: goo.gl/ioFESe.

Meet Quality Engineer Adrien Nicolas, the first GCI employee to be featured in our “Meet the Engineer” series. Read the ...
07/19/2016

Meet Quality Engineer Adrien Nicolas, the first GCI employee to be featured in our “Meet the Engineer” series. Read the full interview with Adrien here: goo.gl/sV8mwo.

Every GCIer's favorite part of volunteering at the Humane Society of Broward County was meeting this amazing fella right...
07/15/2016

Every GCIer's favorite part of volunteering at the Humane Society of Broward County was meeting this amazing fella right here. Rusty is the sweetest and most social dog we have ever seen. Throughout the entire evening, he was constantly going up to every GCI employee for a simple pat on the head or a big hug.

Check out our Yappy Hour photo album for multiple pictures of Rusty and all of his cuteness in action!

If you are interested in learning more about adopting Rusty, or know anyone who might be, check out his profile here: http://humanebroward.com/diamond-in-the-ruff-rusty/. You won't regret it!

This week's Diamond in the Ruff is Rusty.

Gentle lover boy seeking a forever home!

Rusty is the dog of your dreams! He is a 4 year old, Male, Boxer Mix. His big brown eyes and winning smile are enough to make anyone swoon and better yet, he loves to give hugs and kisses! Rusty is housebroken, knows basic commands and is great with people young and old! He is looking for a family that wants a dog who is sweet, gentle and attentive! (Good belly rubbers are a huge plus!) Rusty has simple dreams of owning a bed of his own and having a big chew toy to go along with it! Are you in the business of making dreams come true? Come meet Rusty and watch the magic happen!

For more information on Rusty contact the Humane Society of Broward County at 954-989-3977, Extension 6 for Adoptions. Also visit http://jrdunn.com/diamond-in-the-ruff to see other Dogs and Cats still available.

For our 2nd Goode Deeds event, GCIers had the amazing opportunity to volunteer at the Humane Society of Broward County. ...
07/14/2016

For our 2nd Goode Deeds event, GCIers had the amazing opportunity to volunteer at the Humane Society of Broward County. We spent the evening playing with the shelter animals for a good cause and learning more about HSBC’s mission, including the importance of adopting instead of shopping for pets. Together, we donated more than 100 items on the Humane Society’s wish list. We can only hope we brought as many “Goode Vibes” to the shelter as our four-legged friends brought to us!

GCI’s latest quarterly gift boxes have been assembled and are ready to be sent out! We have personalized them with exclu...
06/28/2016

GCI’s latest quarterly gift boxes have been assembled and are ready to be sent out! We have personalized them with exclusive GCI goodies to show how much we truly appreciate working with our clients.

At GCl, we treat our employees right! Today, we had a professional from Premier Mobile Spa come in and give the office 1...
06/24/2016

At GCl, we treat our employees right! Today, we had a professional from Premier Mobile Spa come in and give the office 10 min massages to reward everyone for their hard work. Happy Friday and hope everyone has a relaxing weekend!

Happy  ! Feeling the heat from   audits? Time to bring in GCI's   engineers!
06/20/2016

Happy ! Feeling the heat from audits? Time to bring in GCI's engineers!

Wrapping up another successful conference with some great   professionals. GCI is looking forward to returning next year...
06/16/2016

Wrapping up another successful conference with some great professionals. GCI is looking forward to returning next year for the 3rd annual Statistics in Validation. Philadelphia - you were great to us!

FDA encourages   manufacturers to increase transparency by sharing easy-to-interpret info with patients http://flip.it/H...
06/13/2016

FDA encourages manufacturers to increase transparency by sharing easy-to-interpret info with patients http://flip.it/H5tZm

As patients increasingly play a more active role in their own healthcare, the US Food and Drug Administration (FDA) on Thursday issued new draft guidance to clarify that medical device manufacturers...

We are so grateful for professionals who take the time to commend us for our work. Check out what a former FDA investiga...
06/09/2016

We are so grateful for professionals who take the time to commend us for our work. Check out what a former FDA investigator had to say after working with GCI on multiple projects!

Looking forward to hearing Roberta Goode speak at IVT's Stats in Validation conference in about a week!
06/08/2016

Looking forward to hearing Roberta Goode speak at IVT's Stats in Validation conference in about a week!

According to CNN, standing desks have been proven to boost work productivity by 46%. Here at GCI, we are constantly sear...
06/08/2016

According to CNN, standing desks have been proven to boost work productivity by 46%. Here at GCI, we are constantly searching for new ways to be more productive for our clients! http://buff.ly/1ZycDj2

We are excited to announce Roberta Goode as Chairperson of IVT’s Statistics in Validation! Please join us and enjoy 20% ...
06/06/2016

We are excited to announce Roberta Goode as Chairperson of IVT’s Statistics in Validation! Please join us and enjoy 20% off registration. Check it out here: http://buff.ly/25IGfBo

Just under a month away from the Statistics in Validation conference! GCI is sponsoring the event and Roberta Goode will...
05/17/2016

Just under a month away from the Statistics in Validation conference! GCI is sponsoring the event and Roberta Goode will be speaking there as well. We would love to have you join us; use this voucher for $500 off your registration - saving you almost 20% off the original fee! Reserve your seat here: http://goo.gl/H3Ugu1

  to when our President, Roberta Goode, won Faculty Member of the Year at the University of Miami for her work in mentor...
04/28/2016

to when our President, Roberta Goode, won Faculty Member of the Year at the University of Miami for her work in mentoring students and preparing them for the workforce! Her acceptance speech was even quoted in a UM news publication!

CORAL GABLES, Fla. (February 4, 2016)—Often it takes a village to get an internship, a job, and a career. That was the message behind the Toppel Career Center’s inaugural Toppel Awards, which were presented Thursday during a ceremony in the BankUnited Center’s Hurricane 100 room.

Wishing our employees with April birthdays a Happy Birthday!
04/21/2016

Wishing our employees with April birthdays a Happy Birthday!

04/12/2016

Steven Niedelman shared that CDRH has an initiative for 2016-2017 to identify external partnerships and mechanisms to support a sustainable 3rd party program to promote quality in the medical device industry. This initiative goes beyond simple compliance!

Kim Trautman is speaking at   about the ISO 13485:2016 changes which have "beefed up requirements for purchasing control...
04/12/2016

Kim Trautman is speaking at about the ISO 13485:2016 changes which have "beefed up requirements for purchasing controls & supplier quality." Trautman also confirmed that FDA will hold medical device manufacturers fully responsible for the content/robustness of their suppliers' PVs. As the manufacturer, "you OWN that process validation," Trautman continued.

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