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Indiana Life Science Entrepreneur to Present at April INpact

April 19, 2013 By Leave a Comment

Indiana has a rich presence of medical device, pharmaceutical, and other life science companies. There is also a surprising number of startups and entrepreneurs in this space. On April 25, 2013, Catherine Tanner, one of Indiana’s life science entrepreneurs, will share her story with INpact, a medical device networking group. Be sure to RSVP.

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INpact – Preparing for FDA Audit

March 18, 2013 By Leave a Comment

There is a great opportunity this Friday (3/22) to hear from Scott Durlacher of Anson Group on preparing for a FDA audit. If you are part of a medical device company, I highly recommend you participate. Having worked with and knowing Scott, he has a ton of experiences and suggestions to assist you in being prepared.

Here is a link to the INpact event page.

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INpact Medical Device Network Meets February 21 at 5:30pm

February 20, 2013 By Leave a Comment

INpact is trying something new in February–an evening event at a cool space known as the Speak Easy. A local vascular surgeon, Dr. George Akingba will be speaking to the group, sharing some of his work and thoughts on healthcare.

Plenty of opportunities to network. Oh, and pizza and beer with your admission.

Check out the INpact Meetup page and RSVP.

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INpact January Event Registration Via QR Code

January 16, 2013 By Leave a Comment

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INpact Is Kicking Off 2013 on January 23, 2013

January 15, 2013 By Leave a Comment

INpact, an Indiana-based medical device network is kicking off 2013 on January 23 from 11:30 – 1:00 at the offices of Bingham Greenbaum Doll. We’re going to try a few new things this year, the first of which is creation of an INpact Meetup group.

Be sure to sign up to join us.

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Companion Diagnostics Webinar on October 30, 2012

October 29, 2012 By Leave a Comment

A colleague, Rob Packard is conducting a webinar on October 30, 2012 for those in IVD medical device industry. Specifically, the webinar is titled “Companion Diagnostics: Regulatory Updates for FDA, EU, Canada”. Rob knows his stuff, especially when it comes to analyzing impact changing regulations will have on bringing new medical products to market.

 

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Check Out Upcoming Medical Device Events

August 9, 2012 By Leave a Comment

Lots of exciting medical device events are approaching, including:

August 21, 2012 – IHIF Life Science Lunch: Stem Cell – R&D Update (Indianapolis, IN)

August 28, 2012 – FDA Public Workshop: Division of Cardiovascular (DCD) 30-Day Notices and Annual Reports Workshop (Silver Spring, MD)

September 6 – 7, 2012 – Medical Devices Summit Midwest (Minneapolis, MN)

September 28, 2012 – Indiana Life Sciences Collaboration Series: Lessons from the School of “Hard Knocks” (Indianapolis, IN)

October 22 – 23, 2012 – Indiana Life Sciences Summit

Be sure to check out these and more from the our Events page.

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Several Medical Device Events in July 2012

July 3, 2012 By Leave a Comment

There are quite a few interesting medical device related events throughout the Midwest, many in Indianapolis, in the month of July.

Check out the CQ Events page for all the details.

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June 7, 2012 – Venture Club of Indiana: Venture Capital Update

May 29, 2012 By Leave a Comment
VCOI_medium      Event Notice
On June 7, the Venture Club of Indiana will be presenting a Venture Capital Update featuring: 

Don Aquilano, Allos Ventures, Indianapolis and Cincinnati
John Diekman, 5AM Capital, Menlo Park, CA
Rob Smith, Petra Capital, Nashville, TN

If you have questions that you would like to submit to the panel, please emailinfo@ventureclub.org.

Sponsored by:

 T2 Systems Logo

Hosted by:

B&T Stacked
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June 15, 2012 – INpact: Navigating & Mitigating Risk for Emerging Technologies

May 29, 2012 By Leave a Comment
Join us at our June meeting when Insurance Management Group will lead a panel of experts on the
topic of “Navigating & Mitigating Risk for Emerging Technologies”.
DATE: June 15, 2012
TIME: 11:30 a.m. – 1:00 p.m.
LOCATION: Bingham Greenebaum Doll LLP
                 10 W. Market St.
                 Suite 2700
                 Downtown Indianapolis MAP
COST: Non-members $20
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May 24, 2012- MWDG Presents Play the Process Validation Game

May 21, 2012 By Leave a Comment
ASQ-Biomedical Division
MWDG Presents Play the Process Validation Game

Univ of Indianapolis Schwitzer Student Center Building #7 Room #013 Indianapolis, IN 46227

Thursday, May 24, 2012 5:30 PM  – 7:30 PM
Details

The MWDG of the ASQ Biomedical Division Presents: Play the Process Validation Game-A Team ExerciseThursday, May 24, 2012, 5:30pm to 8:00pm  

Attendees will be broken into teams. A deck of cards will contain the major steps and tasks of process validation. Each team will have identical decks of cards. Each player of the team will take cards and then sequence them in the proper order. There will also be cards that contain “Punishment” & “Reward” cards to slow down or speed up the teams’ progress. The goal of the game is to design and implement a process validation process by placing the cards in the proper sequence. The team must have the right process sequences to win.

 

Howard Cooper will introduce the project.  He is currently the chairman of the ASQ Midwest Biomedical Discussion Group.

 

 

Location: Univ of Indianapolis, Schwitzer Student Center Building No.7 Room No.013 (on lower level)

 

Food: Hot Buffet Dinner, Beverage and Dessert. 

ASQ Members $12.50-, Non-members $15.00- (0.3 R.U.s Awarded) Walk-ins welcome for $15- cash only at the door, however food and seating can not be guaranteed. To encourage interaction, seating is limited to the first 40 registrants, so sign up soon!   For more information, contact: Ann Stankiewicz at ann.stankiewicz@roche.com

(317) 521-2980

As volunteers in a not-for-profit professional organization ASQ Biomedical, MWDG (Midwest Discussion Group) is committed to providing low cost high value events for biomedical professionals and the local community. We are able to keep our costs low by utilizing a registration system that incurs minimal administrative overhead expenses and minimizes excess time and effort spent by our volunteers to bring you these events. Please help us continue providing low cost quality programs to you by using the system that works well for us. 

This Roundtable Discussion will utilize the synergy of our well-versed Subject Matter Expert along with your Regional Industry Peers.

 

 
Registration

Please indicate the quantity you would like for each type of registration shown below. Then click on “Continue” to confirm your order selections and total. After that we will ask for your name and address information and your payment information to complete your order on our secure server.
ASQ members
Order at $12.50 each
Price: $12.50 Processing: $0.00 Total: $12.50
Non member
Order at $15.00 each
Price: $15.00 Processing: $0.00 Total: $15.00

 

Activity Questionnaire

ASQ-Biomedical Division has requested that its customers provide the following information to better help it fulfill your order. Required questions must be answered in order to complete your order.
You may submit on-line questions for discussion at the event.

  

ASQ-Biomedical Division Purchase/refund policy: The default refund policy is to provide full refunds up to 14 days before the event, and future credits after that time. Individual events may have different refund policies, and these will be noted on the registration page. Normally, the $15-$25 discussion group meetings are non-refundable. ASQ Biomedical Division reserves the right to cancel, reschedule any event, or to change speakers. Please be advised that ASQ Biomedical Division or ASQ Headquarters is not responsible for any airfare penalties, or hotel charges that may be incurred due to sold out, cancelled, or rescheduled events.Acteva’s Purchase/refund policy: Refunds and cancellations are provided only at the discretion of the organization hosting or sponsoring this event. Acteva issues credits only when directed to do so by the sponsoring organization. Contact refunds@acteva.com or the sponsoring organization for further details.
Filed Under: Events

June 5, 2012- The State of STEM Education In Indiana: Challenges Today and Strategies for Future Success

May 14, 2012 By Leave a Comment

Hello,

Please join us for our next Frameworx session on Tuesday, June 5 at 8:00 a.m. – The State of STEM Education In Indiana: Challenges Today and Strategies for Future Success. In this session, Vince Bertram, CEO of Project Lead the Way, will start the discussion with a quick overview of the current state of science technology engineering and math (STEM) education in Indiana, the U.S. and throughout the world.

The keynote will be followed by a panel of STEM education experts representing Woodrow Wilson Fellows, New Tech High School, Conexus, National Math and Science Initiative, Indiana Department of Education, I-STEM Resource Network, Eli Lilly and Company, and Teach for America. The group will present the success of current programs as well as share the challenges and possible strategies for future success in Indiana.

D’Amore 48th floor, Top of Chase Building

Register here

Event Sponsors: Eli Lilly and Company and Cook Group

Printing Sponsor for the Series: Miles Printing
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May 23, 2012- 2012 FDA Regulatory 101 Course

May 13, 2012 By Leave a Comment

2012 FDA Regulatory 101 Course Wednesday, May 23, 2012

Approved for 5.3 Hours of CLE Credit

Presented by a host of Indiana Medical Device Manufacturing Sector Experts

Sponsored by Samco & Associates, Inc.

Stericycle ExpertRECALL

2 Sponsorships Available (Sponsorship includes promotions, signage at the event as well as a shared table for materials distribution. Sign up at the bottom of the Registration Form)

Program Agenda

8:30-9:00 am Registration / Continental Breakfast / Networking
9:00-9:15 Welcome Ralph Hall, Counsel, Faegre Baker Daniels
9:15-10:00 Clinical Trials and IDEs   21 CFR 50, 54, 812   Roles and responsibilities   FDA submission process   Informed consents, IRBs, etc.   European Issues Keli Hankee, Manager, Clinical Affairs, Biomet, Inc.
10-00-10:15 Break
10:15-11:15 Submissions   PMA requirements   Submission contents   Process and issues   510(k) requirements   Process and requirements   513(g) Russell Gray, Sr. Regulatory Consultant The Anson Group
11:15-11:45 Combination Products Suzanne O’Shea, Partner Faegre Baker Daniels
11:45-12:15 Complaint Handling/Corrections and Removals Part 806, Part 7   Part 803 Dale Miller, Manager, Regulatory Affairs Zimmer, Inc.
12:15-1:15 Lunch and Networking
1:15-2:15 QSR Overview   820   Design controls   Management responsibility   Process controls   Adverse Event Reporting   Other QSR topics Chris Kilander Regulatory Affairs Manager Cook, Inc.
2:15 Break
2:30-3:15 Advertising and Promotional Controls Danelle Miller, Global Regulatory Counsel Roche Diagnostics
3:15-4:00 Enforcement / Wrap Up Administrative, civil and criminal   Other Provisions (qui tam, 1001, 371) Ralph Hall, Counsel Faegre Baker Daniels

 

Register Online Now! Use your username and password to expedite registration by prefilling the registration form!

Registration Only: 8:30 am Program: 9:00 – 4:00 pm Location: Montage Catering Facility, 8580 Allison Pointe Blvd., Indianapolis, IN 46250
Members: $195 per person (Member discounts apply when registering more than 4 attendees at the same time)
Non-Members: $275 per person For more information or to join the IMDMC, please contact Blake Jeffery at IMDMCoffice@ameritech.net.

IMDMC.logo.gif Click here to join the IMDMC!

 

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May 18, 2012- GIIRT Breakfast: Make Organizational Change Happen with the “Patterns of Innovation”

May 13, 2012 By Leave a Comment
May 18 GIIRT Breakfast: Make Organizational Change Happen with the “Patterns of Innovation”
Where:

Suite D 40 Executive Dr. Ste D Carmel, IN 46032 Driving Directions

When: Friday May 18, 2012 from 8:00 AM to 9:30 AM EDT Add to my calendar
Overcoming organizational stagnation is exhausting and difficult…. unless you know how to make small changes in the right places.
It’s all about recognizing the “Patterns of Innovation,” key triggers and symptoms that are common among effective, innovative workplaces.  Instead of expending energy by fighting an uphill battle, you can use tipping point leadership and a “heads up” mindset to create lasting, effective change.  Dr. Jan Byars will help May GIIRT attendees understand these patterns and begin utilizing simple techniques that begin turning ordinary individuals into agents of change.

 

The event will take place on May 18th from 8:00-9:30AM at Suite-D in Carmel. Registration costs $20 per registrant and includes breakfast, relevant learning, and access to some of Indianapolis’s most innovative minds.

 

 
Get more information
Register Now!
I can’t make it
If you have any questions about the Greater Indy Innovation Roundtable or want to learn more about student or non-profit pricing, please call (317) 814-5294.

 

We appreciate your interest in GIIRT and we look forward to seeing you at our next event!

 

Sincerely,

 

Doug McColgin
Greater Indy Innovation Roundtable
Filed Under: Events

May 14, 2012- RAPS Indiana Chapter Event: Key Regulatory Trends in 2011 Biological Approvals

May 1, 2012 By Leave a Comment

RAPS Indiana Chapter Event: May 14th, 2012

 

Please join us for a lively discussion directed by Jody Roth about “Key Regulatory Trends in 2011 Biological Approvals” at the next RAPS Indiana Chapter event.  The event will be held on May 14th, 2012 from 4:00pm-6:00pm at the IUETC Ice Miller Room.  To register, click here.

Filed Under: Events
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