June Event: Current Hot Topics within FDA and Inspection Preparation


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


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


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