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Chemistry Extractables and Leachables

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PDA Midwest Dinner Event


Chemistry Extractables and Leachables

The PDA Midwest Chapter is pleased to have a lab tour and technical presentation at Nelson Labs in Itasca, IL for our June 2024 event to focus on topics related to Chemistry Extractables and Leachables testing for the pharmaceutical industry

Presentations:
Submissions to the FDA: What to Watch Out for From a CRO Perspectives
Presented by: Raymond Colton, Director of E&L Services, Nelson Labs

Two decades following the release of the FDA Draft Guidance on Container/Closure Systems for Packaging Human Drugs and Biologics, the FDA has recently communicated informal updates regarding common observations when reviewing submissions to the Agency (CDER). These communications include general advice and specific expectations aimed at optimizing study design, evaluation, and reporting—elements not addressed in the original 1999 Draft Guidance Document.

This presentation will highlight the major observations from the FDA, explaining the origins of these updated requirements and offering guidance on addressing them effectively. Case studies from a CRO perspective will be presented to bolster these new viewpoints. Furthermore, the revised expectations from the FDA will be examined, alongside recommendations on incorporating them into the design, interpretation, or reporting of a container/closure system qualification program, particularly from an extractables/leachables (E/L) perspective.

 

Agenda & Venue


Central Time Zone

Activity Time (CST)
Registration/Cocktails/Networking 5:00pm – 6:00pm
Dinner 6:00pm – 7:00pm
Laboratory Tour  7:00pm – 7:45pm
Presentation  7:45pm – 8:15pm
Q&A with Presenter / Closing 8:15pm – 8:30pm

Location

Nelson Laboratories
1500 W. Thorndale Ave.
Itasca, IL 60143
(630) 285-9121
 
 

Tickets


Pricing is $70 for General Admission

Tickets

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Nelson Laboratories General Admission
$ 70.00
19 available

 

Thank you sponsors


Annual Sponsors

Details

Date:
June 20
Time:
5:00 pm - 8:30 pm
Cost:
$70.00

Organizer

Mark Bogs

Venue

Nelson Laboratories
1500 W Thorndale Ave
Itasca, IL 60143 United States
+ Google Map
Phone
630-285-9121