ISO 14155 and FDA Requirements – Trials Conducted at the Research Site

Join this live webinar program as we delve into medical devices and investigational medical devices.

The presenter will provide information on FDA regulations and ISO requirements along with the similarities and differences for device trials conducted at the research site.

Date: December 5, 2023
Time: 12:00 – 1:00 PM ET

Upon completion of this continuing education program, participants should be able to:

• Define what is considered a medical device.
• Define and provide examples of an investigational medical device.
• FDA regulations and ISO requirements for device trials conducted at the research site.

Speaker:

Pranali Wandile, MS, CCRP
Clinical Research Manager
South Carolina Clinical Research LLC

Pranali Wandile, MS, CCRP currently works as the Clinical Research Manager at South Carolina Clinical Research LLC, in Orangeburg, SC. She has been in Clinical Research for the past 15 years. Pranali received a master’s degree in clinical research administration from Eastern Michigan University. She has successfully managed clinical trials of several therapeutic areas and is very passionate about medical science and quality conduct of clinical research. Her research interests include: Clinical Research, quality assurance, clinical trial regulation, ICH-GCP guidelines, Clinical trial conduct, clinical trial protocols, clinical trial compensation, clinical trial design, study participant enrolment and retention, FDA regulations for the clinical research conduct, Cardiology, Nephrology, Oncology, and Infectious Disease.

Approved for 1.0 ACRP Contact Hours

The WebEx service used for ACRP webinars includes a feature that allows audio and any documents and other materials exchanged or viewed during the session to be recorded. By joining this webinar, you automatically consent to such recordings. If you do not wish to participate in the live recording, we recommend that you register to receive the link to the webinar replay.