MARSQA

Events

Upcoming Events

13 June 2024
MARSQA June Lunch and Learn Webinar: Laboratory Developed Tests (LDTs) and FDA’s Final Rule to Change the Status Quo

Presented by: Gowri Somayaji

According to FDA, LDTs are in-vitro diagnostic products (IVDs) that are intended for clinical use and are designed, manufactured, and used within a single clinical laboratory that meets certain laboratory requirements. Many clinical labs and biomarker companies have developed such tests that are used for diagnosis and treatment of subjects. LDTs were allowed be used without evidence of clinical validation and/ or FDA review of their design and manufacturing due to FDA’s general enforcement discretion. A new rule is looking to change all that. This seminar will talk about the changes and the potential impact to LDT developers and their customers.

Gowri Somayaji is a QA Auditor at Johnson & Johnson. She currently manages the external clinical lab audit program at J&J and has been interested in LDTs for the last few years of her auditing career. She has been involved with MARSQA since 2017, actively on the MARSQA BoD from 2018 to 2023. She has also been presenting on topics of her interest at MARSQA and SQA over the years, with her main focus being research data integrity and clinical labs. Gowri is an alumni of Temple University RA/QA MS program and has been in the pharmaceutical industry for almost 2 decades.

Register Online

24 October 2024
MARSQA Membership Meeting

Peddler's Village - Cock' n Bull Restaurant - Lahaska, PA

Mark your calendar for our fall MARSQA Membership Meeting. Registration will be available at a later date. The registration rate for MARSQA members will be $80 and $100 for nonmembers.

MARSQA CVC Activities

MARSQA Members, join us for these upcoming CVC activities! The MARSQA CVC has some exciting activities planned this year. For more details, or to receive meeting access information, reach out to Denise Botto at denise.botto@syneoshealth.com.

  • CVC Monthly Meeting: First Tuesday of the month from 9:00-10:00 AM ET

Recent Events

23 May 2024
MARSQA May Lunch and Learn Webinar Series
CLIA-Accredited Labs: History and Importance – Where Are We Now? - Erica Falcon
14 May 2024
MARSQA CVC Roundtable Event
17 October 2023
MARSQA CVC Roundtable Event
14 September 2023
MARSQA Membership Meeting
27 July 2023
MARSQA Lunch & Learn Webinar Series
FDA Inspection Interactions - Melissa Hochhaus and Julia Roberts
28 June 2023
MARSQA Lunch & Learn Webinar Series
A Crash Course on Pharmacovigilance - Larry Thomas
18 May 2023
MARSQA Lunch & Learn Webinar Series
FDA BIMO Sponsor Compliance Program Update - Nicole Victoria
9 February 2023
MARSQA Lunch & Learn Webinar Series
Cyber Security Essentials - Jason Kentner

Stay tuned for future event information.