June Event: Current Hot Topics within FDA and Inspection Preparation
June 4, 2018
Monthly Program:
Wednesday, 20 June 2018
Current Hot Topics within FDA and Inspection Preparation
Program Speaker:
Sarah B. Tanksley, M.S.
President & CEO, Tanksley Consulting Group
Event Agenda:
Date:
Wednesday, June 20th, 2018
Time:
5:15 – 6:00 PM Registration & Snacks
6:00 – 6:05 PM Welcome and Announcements
6:05 – 7:05 PM Program Presentation
7:05 – 7:30 PM Q & A
LOCATION:
BD (former CareFusion)
3770 Torrey View Court
San Diego, CA 92130
View Map
Program Topic:
The professional field of regulatory advertising and promotion has become increasingly essential to pharmaceutical companies. To ensure compliance with this progressive and continually changing field, a regulatory advertising and promotion professional must have a comprehensive understanding of laws and regulations governing prescription drug promotion.
Program Summary:
The Food and Drug Administration (FDA) conducts careful inspections of regulated facilities to determine a firm's compliance with regulations and the Food, Drug and Cosmetic Act. Inspections are one of the many ways FDA protects the public health. The prospect of inspections can be intimidating but being prepared and having your site ready can help reduce anxiety before FDA arrives.
This talk will provide the most recent updates on some of the challenges within the FDA today, including the following:
Enforcement actions and warning letter trends
Mutual recognition program for inspections
Cellular and gene therapy regulatory strategies
Regulation of laboratory developed tests
Status of the Quality Metrics reporting program
New serialization requirements
Also, Ms. Tankslwy will discuss how to prepare for an FDA inspection in today's regulatory environment. Topics will include:
Preparing your facility to face an FDA inspection
Training subject matter experts on how they should conduct themselves during questioning
Handling challenging topics and contentious conversations
Understanding specific behaviors that FDA investigators are trained to recognize and record
Speaker Biography:
Sarah Tanksley has been consulting in the area of pharmaceutical quality and compliance since 2011. She has led several remediation projects involving breaches in data integrity and has led audits which have detected both gaps and falsified data. She regularly lectures on the topic of data integrity to audiences worldwide. Prior to consulting, she was a Consumer Safety Officer in the Office of Compliance, Center for Biologic Evaluation and Research (CBER) at the Food and Drug Administration, where she reviewed new applications for approval and conducted prior approval inspections as well as routine GMP inspections. Sarah joined the FDA after several years as biologist in the laboratory at the National Institutes of Allergy and Infectious Disease, National Institutes of Health. Sarah has a MS in Biochemistry and Molecular Biology from Georgetown University, a MS in Regulatory Science from Johns Hopkins University, and a BS in Biology from the College of William and Mary.
Please make your reservation early. The online registration due date is Monday, June 18th 2018. Credit Cards are accepted online only. Cash and Check are accepted at the door.
Online Pre-registration (through Monday June 18th, 2018):
$15 SDRAN Member, $25 Non-Member
Onsite Registration:
$25 SDRAN Member, $35 Non-Member
For Questions Email: programs@sdran.org
DIRECTIONS:
From the North 5:
I-5 South toward San Diego
Exit toward Carmel Mountain Rd
Left onto Carmel Mountain Rd
Left onto Torrey View Court
Facility is on the right
From the South 5:
I-5 North toward Del Mar
Merge onto I-5 local Bypass
Take Carmel Mountain Rd exit (32)
Turn right onto Carmel Mountain Rd
Turn left onto Torrey View Court
Facility is on the right