Sponsorship for PDA Chapter Dinner  $250.00 Two Available

Includes:

1 Admission

Table Top Display

2 Minute Podium Presentation about Company's Services/Products

PDA Midwest is delighted to present industry experts from ICU Medical and WuXi AppTec. Karen Sargis, Biocompatibility Manager at ICU Medical, will be presenting on biocompatibility requirements for product evaluation. Dr. Vanessa Hasse, Associate Director of Regulatory Toxicology at WuXi Apptec, will be presenting on Biocompatibility Testing as part of Biological Evaluation and ISO 10993.

Biocompatibility Requirements for Product Evaluation

Biocompatibility testing is a growing area of interest in the development and registration of combination products. This session will focus on the basic concepts of biocompatibility testing for device platforms, as well as the strategies to execute them in a meaningful way such that excessive animal testing is not required.

Biocompatibility Testing Methodologies

Biocompatibility testing is a critical part of the regulatory approval process for medical devices as even the best designed products can produce unintended complications if the materials used cause a biological reaction in the patient. Some common tests are cytotoxicity, sensitization and irritation tests; however, other test methods may be needed based on usage of the product. ANSI/AAMI/ISO 10993-1 describes the process for biological evaluation of medical devices and the tests that are required. This presentation will provide detail into the test methods.

This dinner meeting will consist of a networking hour, dinner and presentations from our guests.

Pricing:  $65.00 (non members)  $55.00 (with PDA membership)

VEGETARIAN MEALS AVAILABLE - PLEASE INDICATE DURING REGISTRATION

Meeting Details and Agenda:

Sponsorship Opportunities

2 Sponsorships - Click here for sponsorship

Join PDA Midwest on October 10th and 11th!

October 10th Welcome Reception (7pm):

This is a wonderful opportunity to learn more about PDA Midwest Chapter's latest activities, volunteer opportunities while networking with other industry colleagues and board members. Don't miss out on this opportunity. The event will take place at Ram Restaurant & Brewery in Indianapolis for some appetizers and drinks.

October 11th All Day Seminar (8am):

Once again,  Eli Lilly & Company will be hosting this all day event at the Eli Lilly and Company Manufacturing and Quality Learning Center (MQLC) on the near west side of Indianapolis. Breakfast will be served starting at 8:00 am along with registration for the event. Refreshments will be provided during two break periods, along with lunch for all attendees and presenters for this all-day event. Please join the PDA Midwest at the October 11^th All-Day Event held at Eli Lilly’s Manufacturing & Quality Learning Center in Indianapolis.  Speakers will discuss risk management associated with Environmental Monitoring, Cleaning Validation, Sanitization Validation, Quality Risk Management and Non-Sterile Manufacturing. 

Sponsorship Opportunities

Sponsors : 1 Networking Reception Platinum ($1000),  1 Event Platinum ($1000), 12 Silver ($500)

To Purchase a Sponsorship:

• Purchase Sponsorship

Pricing is $115 for Members, $125 for Non-Members.

VEGETARIAN MEALS AVAILABLE - PLEASE INDICATE DURING REGISTRATION.

Networking Event Platinum Sponsorship for Sterility Assurance & Risk Mitigation. $1,000. One available

Includes:

Company's Name Highlighted at Networking Event

2 Admissions

Table Top Display (at the All Day Event)

2-3 Minute Podium Presentation about Company's Services/Products

Platinum Sponsorship for Sterility Assurance & Risk Mitigation. $1,000. One available

Includes:

Company's Name Highlighted at Lunch Buffet

2 Admissions

Table Top Display

2-3 Minute Podium Presentation about Company's Services/Products

Silver Sponsorship for Sterility Assurance & Risk Mitigation. $500. Twelve available.

Includes:

1 Admission

Table Top Display