cGMP and QSR Inspections Best Practices FDA and FDB Panel Discussion

by | Aug 6, 2023 | SDRAN Events

Event Agenda

DATE:       Wednesday, 27 September 2023

TIME*: 5:30 – 6:00 PM   Light Dinner and Networking (In-Person)

             6:00 – 6:05 PM  Welcome and Announcements (In-Person and Virtual)

            6:05 – 8:00 PM  Panel Discussion (In-Person and Virtual)

* Times are in Pacific Daylight Time (PDT)

LOCATION: This event is being offered both IN PERSON and VIRTUALLY. When you register, you will be able to choose how you will attend the event.  No walk-ins allowed. Please register for this event by the registration deadlines.

                  If you register to attend IN PERSON, please join us at:

      Neurocrine Biosciences, Inc.

12790 El Camino Real

San Diego, CA 92130

              •  Click here to register for this event (IN-PERSON attendance option)

                  If you register to attend VIRTUALLY, you will receive the Zoom link 1-2 days before the event.

              • Click here to register for this event (VIRTUAL attendance option)

Program Details

Fundamentals of Electronic Medical Device Reports (eMDRs) to FDA

Come hear directly from Food and Drug Administration (FDA) investigators and California Food and Drug Branch (FDB) supervisors on how they approach cGMP and QSR inspections, recent inspection observation trends, and managing inspections best practices.

Panelist Biographies:

Oscar I. Alarcon
Senior Environmental Scientist (Supervisory)
California Department of Public Health
Food and Drug Branch
Drug & Medical Device Compliance & Enforcement Section
Regulatory Compliance Unit-North

Dr. Raymond W. Brullo, DPM (Doctor of Podiatric Medicine)
Compliance Officer, Division 3/West Compliance Branch
Office of Medical Devices and Radiological Health Operations
OMDRHO|ORA|USFDA.

Katherine E. Jacobitz
Captain, U.S. Public Health Service
Director Investigations Branch
Division of Pharmaceutical Quality Operations IV
Office of Regulatory Affairs
U.S. Food and Drug Administration

April Lee
Supervising Drug and Medical Device Inspector
California Department of Public Health
Division of Food and Drug Safety
Food and Drug Branch
Drug and Medical Device Compliance Enforcement Section
Regulatory Compliance Unit-South

Harlan Loui
Section Chief
Drug and Medical Device Compliance and Enforcement
California Department of Public Health
Food and Drug Branch

 

Registration Information:

 No walk-ins allowed. Please register for this event by the registration deadlines.

Click here to register for this event (IN-PERSON attendance option)

Click here to register for this event (VIRTUAL attendance option)

Contact

[email protected]

Pricing Registration

Registrant Type

In-Person price

(Registration ends Sunday, 24 September 2023)

Virtual price

(Registration ends Tuesday, 26 September 2023)

Member

$25

$10

Lifetime

$25

$10

Non-member

$35

$15

Cancellation Policy

There will be no refunds for cancellations.