On September 19, 2019 join PDA Midwest at a new venue, Pinstripes, for an engaging and dynamic dinner meeting to discuss Cell & Gene therapy challenges and insights from the perspectives of both the client and the CMO. The agenda includes presentations from Ron Smith, Director, External Supply Integration Quality at the Janssen Pharmaceutical Companies and Steven Falcone, Vice President, Quality, ThermoFisher Viral Vector Services on current topics in Cell and Gene Therapy Quality and Manufacturing.

Location:

Pinstripes

1150 Willow Road

Northbrook, IL 60062

1-847-480-2323

Agenda:

5:00pm         Registration, cocktails, and networking

6:00pm         Dinner

7:00pm         Presentations

Silver Sponsorship: $250. Two available.

Includes:

1 Admission

Table Top Display

Join PDA Midwest on October 2nd and 3rd!

October 2nd 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 3rd 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 3^rd 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

The PDA Midwest Chapter is pleased to present two speakers for our November 2019 event to focus on topics related to the development and maintenance of the chemistry, manufacturing and controls (CMC) section of a drug application.

1. Anatomy of the CMC and its Life Cycle Management within the eCTD.

Presented by Daniel J. Hoch Ph.D. Vice President, Protocol Link Inc.

The presentation will focus on the composition and management of the Chemistry, Manufacturing and Controls (CMC) Section applicable to drug product submissions to the US-FDA. It will outline the structural elements of the Common Technical Document (CTD) as the framework for presentation of the CMC, as well as its life-cycle management.

The presentation will include:

• A summary of the origin of the Common Technical Document (CTD), established as the framework for presentation of the CMC, through its transition to the current electronic version (eCTD) associated with electronic publishing.
• An outline of the CMC anatomy (granularity, function, content and structure) as organized within the eCTD.
• Case-study illustrating multi-disciplinary collaboration activities associated with the preparation of the CMC and its life-cycle management.

2. CMC Post Approval Strategies for Biologics

Kathy Lee, Senior Research Advisor CMC, Eli Lilly and Company

The CMC post approval global regulatory landscape is an exciting and challenging space for biologics. This talk will focus regulatory requirements across the globe (EU, Japan, South American and South East Asia) and strategies for managing your global regulatory footprint.