Discussion: View Thread

​Lindsey,

Thanks for getting some communication going in the group here.  I am fairly new to the CO-Denver area and work as a Director of Quality for a small medical device company, PharmaJet, in Golden.  I moved from Saint Louis where I was the Director of Quality & Regulatory for companies called Surgical Instrument Manufacturers (SIM) (Contract Manufacturing) and CoreLink (Specification Developer).  My current company is very active with CDRH, CBER and the international regulatory space.

I am looking forward to developing a Regulatory and Quality network here in Colorado.  Thanks for connecting me to this group discussion!

Regards,

Steve Jones

------------------------------
Stephan Jones
Arvada, CO
United States
------------------------------

Welcome Steve!

Thanks much for telling the group about your background and where you sit today. I look forward to seeing where this discussion leads into the future. If you have any ideas about timing/locations for the group to meet for an initial discussion, please let us know.

Have a great weekend,
Lindsey

------------------------------
Lindsey Summers, MBA
Director, Pharmaceutical Consulting Division Green Key Resources, LLC
Denver, CO
Direct: 720.543.8692
Mobile: 303.437.0391
lsummers@greenkeyllc.com
www.linkedin.com/in/lindseysummers

http://www.greenkeyllc.com/ph/

Regulatory Affairs / Medical Writing & Publications / Medical Communications & Information / Clinical Operations / Clinical Quality / Drug Safety / Data Management / SAS Programming / Biostatistics / Drug Development Project Management / Medical Affairs & Monitoring / Epidemiology / Health Outcomes

*Receive up to1500 for referring a colleague*

Please note that in the state of California, Green Key conducts business under the name GK Pacific, LLC.
------------------------------

Original Message:
Sent: 24-Jul-2018 10:32
From: Stephan Jones
Subject: Introduction

​Lindsey,

Thanks for getting some communication going in the group here.  I am fairly new to the CO-Denver area and work as a Director of Quality for a small medical device company, PharmaJet, in Golden.  I moved from Saint Louis where I was the Director of Quality & Regulatory for companies called Surgical Instrument Manufacturers (SIM) (Contract Manufacturing) and CoreLink (Specification Developer).  My current company is very active with CDRH, CBER and the international regulatory space.

I am looking forward to developing a Regulatory and Quality network here in Colorado.  Thanks for connecting me to this group discussion!

Regards,

Steve Jones

------------------------------
Stephan Jones
Arvada, CO
United States
------------------------------

Hello,

I would love it if our Colorado Group could meet up, perhaps sponsor some trainings and/or workshops.  I was in Chicago for training and happen to be in town when the Chicago RAPS chapter was having a training, so I attended.  It was great and they do it regularly.  I would be willing to help with such an event.

------------------------------
Kathaleen DeBarris, RAC
RAQA Analyst
Boulder CO
United States
------------------------------

Original Message:
Sent: 03-Aug-2018 18:13
From: Lindsey Summers
Subject: Introduction

Welcome Steve!

Thanks much for telling the group about your background and where you sit today. I look forward to seeing where this discussion leads into the future. If you have any ideas about timing/locations for the group to meet for an initial discussion, please let us know.

Have a great weekend,
Lindsey

------------------------------
Lindsey Summers, MBA
Director, Pharmaceutical Consulting Division Green Key Resources, LLC
Denver, CO
Direct: 720.543.8692
Mobile: 303.437.0391
lsummers@greenkeyllc.com
www.linkedin.com/in/lindseysummers

http://www.greenkeyllc.com/ph/

Regulatory Affairs / Medical Writing & Publications / Medical Communications & Information / Clinical Operations / Clinical Quality / Drug Safety / Data Management / SAS Programming / Biostatistics / Drug Development Project Management / Medical Affairs & Monitoring / Epidemiology / Health Outcomes

*Receive up to1500 for referring a colleague*

Please note that in the state of California, Green Key conducts business under the name GK Pacific, LLC.

Original Message:
Sent: 24-Jul-2018 10:32
From: Stephan Jones
Subject: Introduction

​Lindsey,

Thanks for getting some communication going in the group here.  I am fairly new to the CO-Denver area and work as a Director of Quality for a small medical device company, PharmaJet, in Golden.  I moved from Saint Louis where I was the Director of Quality & Regulatory for companies called Surgical Instrument Manufacturers (SIM) (Contract Manufacturing) and CoreLink (Specification Developer).  My current company is very active with CDRH, CBER and the international regulatory space.

I am looking forward to developing a Regulatory and Quality network here in Colorado.  Thanks for connecting me to this group discussion!

Regards,

Steve Jones

------------------------------
Stephan Jones
Arvada, CO
United States
------------------------------

HI Kathaleen,

Wonderful suggestions and happy you had a great experience in Chicago. This is something we are looking to duplicate here locally. Would you be available for the September 6th meet-up to tell us more about what you enjoyed and add your insight?

Would love to see you there!
Lindsey

------------------------------
Lindsey Summers, MBA
Director, Pharmaceutical Consulting Division Green Key Resources, LLC
Denver, CO
Direct: 720.543.8692
Mobile: 303.437.0391
lsummers@greenkeyllc.com
www.linkedin.com/in/lindseysummers

http://www.greenkeyllc.com/ph/

Regulatory Affairs / Medical Writing & Publications / Medical Communications & Information / Clinical Operations / Clinical Quality / Drug Safety / Data Management / SAS Programming / Biostatistics / Drug Development Project Management / Medical Affairs & Monitoring / Epidemiology / Health Outcomes

*Receive up to1500 for referring a colleague*

Please note that in the state of California, Green Key conducts business under the name GK Pacific, LLC.
------------------------------

Original Message:
Sent: 06-Aug-2018 11:09
From: Kathaleen DeBarris, RAC
Subject: Introduction

Hello,

I would love it if our Colorado Group could meet up, perhaps sponsor some trainings and/or workshops.  I was in Chicago for training and happen to be in town when the Chicago RAPS chapter was having a training, so I attended.  It was great and they do it regularly.  I would be willing to help with such an event.

------------------------------
Kathaleen DeBarris, RAC
RAQA Analyst
Boulder CO
United States

Original Message:
Sent: 03-Aug-2018 18:13
From: Lindsey Summers
Subject: Introduction

Welcome Steve!

Thanks much for telling the group about your background and where you sit today. I look forward to seeing where this discussion leads into the future. If you have any ideas about timing/locations for the group to meet for an initial discussion, please let us know.

Have a great weekend,
Lindsey

------------------------------
Lindsey Summers, MBA
Director, Pharmaceutical Consulting Division Green Key Resources, LLC
Denver, CO
Direct: 720.543.8692
Mobile: 303.437.0391
lsummers@greenkeyllc.com
www.linkedin.com/in/lindseysummers

http://www.greenkeyllc.com/ph/

Regulatory Affairs / Medical Writing & Publications / Medical Communications & Information / Clinical Operations / Clinical Quality / Drug Safety / Data Management / SAS Programming / Biostatistics / Drug Development Project Management / Medical Affairs & Monitoring / Epidemiology / Health Outcomes

*Receive up to1500 for referring a colleague*

Please note that in the state of California, Green Key conducts business under the name GK Pacific, LLC.

Original Message:
Sent: 24-Jul-2018 10:32
From: Stephan Jones
Subject: Introduction

​Lindsey,

Thanks for getting some communication going in the group here.  I am fairly new to the CO-Denver area and work as a Director of Quality for a small medical device company, PharmaJet, in Golden.  I moved from Saint Louis where I was the Director of Quality & Regulatory for companies called Surgical Instrument Manufacturers (SIM) (Contract Manufacturing) and CoreLink (Specification Developer).  My current company is very active with CDRH, CBER and the international regulatory space.

I am looking forward to developing a Regulatory and Quality network here in Colorado.  Thanks for connecting me to this group discussion!

Regards,

Steve Jones

------------------------------
Stephan Jones
Arvada, CO
United States
------------------------------

I'd be willing to attend. Can you email me the particulars?  My email address is kat.debarris@gmail.com

Thank you

------------------------------
Kathaleen DeBarris, RAC
RAQA Analyst
Boulder CO
United States
------------------------------

Original Message:
Sent: 09-Aug-2018 12:34
From: Lindsey Summers
Subject: Introduction

HI Kathaleen,

Wonderful suggestions and happy you had a great experience in Chicago. This is something we are looking to duplicate here locally. Would you be available for the September 6th meet-up to tell us more about what you enjoyed and add your insight?

Would love to see you there!
Lindsey

------------------------------
Lindsey Summers, MBA
Director, Pharmaceutical Consulting Division Green Key Resources, LLC
Denver, CO
Direct: 720.543.8692
Mobile: 303.437.0391
lsummers@greenkeyllc.com
www.linkedin.com/in/lindseysummers

http://www.greenkeyllc.com/ph/

Regulatory Affairs / Medical Writing & Publications / Medical Communications & Information / Clinical Operations / Clinical Quality / Drug Safety / Data Management / SAS Programming / Biostatistics / Drug Development Project Management / Medical Affairs & Monitoring / Epidemiology / Health Outcomes

*Receive up to1500 for referring a colleague*

Please note that in the state of California, Green Key conducts business under the name GK Pacific, LLC.

Original Message:
Sent: 06-Aug-2018 11:09
From: Kathaleen DeBarris, RAC
Subject: Introduction

Hello,

I would love it if our Colorado Group could meet up, perhaps sponsor some trainings and/or workshops.  I was in Chicago for training and happen to be in town when the Chicago RAPS chapter was having a training, so I attended.  It was great and they do it regularly.  I would be willing to help with such an event.

------------------------------
Kathaleen DeBarris, RAC
RAQA Analyst
Boulder CO
United States

Original Message:
Sent: 03-Aug-2018 18:13
From: Lindsey Summers
Subject: Introduction

Welcome Steve!

Thanks much for telling the group about your background and where you sit today. I look forward to seeing where this discussion leads into the future. If you have any ideas about timing/locations for the group to meet for an initial discussion, please let us know.

Have a great weekend,
Lindsey

------------------------------
Lindsey Summers, MBA
Director, Pharmaceutical Consulting Division Green Key Resources, LLC
Denver, CO
Direct: 720.543.8692
Mobile: 303.437.0391
lsummers@greenkeyllc.com
www.linkedin.com/in/lindseysummers

http://www.greenkeyllc.com/ph/

Regulatory Affairs / Medical Writing & Publications / Medical Communications & Information / Clinical Operations / Clinical Quality / Drug Safety / Data Management / SAS Programming / Biostatistics / Drug Development Project Management / Medical Affairs & Monitoring / Epidemiology / Health Outcomes

*Receive up to1500 for referring a colleague*

Please note that in the state of California, Green Key conducts business under the name GK Pacific, LLC.

Original Message:
Sent: 24-Jul-2018 10:32
From: Stephan Jones
Subject: Introduction

​Lindsey,

Thanks for getting some communication going in the group here.  I am fairly new to the CO-Denver area and work as a Director of Quality for a small medical device company, PharmaJet, in Golden.  I moved from Saint Louis where I was the Director of Quality & Regulatory for companies called Surgical Instrument Manufacturers (SIM) (Contract Manufacturing) and CoreLink (Specification Developer).  My current company is very active with CDRH, CBER and the international regulatory space.

I am looking forward to developing a Regulatory and Quality network here in Colorado.  Thanks for connecting me to this group discussion!

Regards,

Steve Jones

------------------------------
Stephan Jones
Arvada, CO
United States
------------------------------