Atlanta Chapter Webcast: Annual Breakfast with the Atlanta Southeast District FDA Office

2.0
RAC Credits
Chapter EventsChapter Events
Friday, 02 December 2022 (9:00 AM) - Friday, 02 December 2022 (11:00 AM) Eastern Time (US & Canada)

Representatives from the Atlanta District/Southeast Region of FDA will engage directly with regulatory professionals in a virtual breakfast, presenting the latest compliance and enforcement related topics and asking attendees questions.

REGISTRATION FEES

Member: $0
NonMember: $25


LEARNING OBJECTIVES

Learn about current compliance and enforcement trends at the FDA


WHO SHOULD ATTEND

Regulatory Affairs, Quality Control, Quality Assurance, Manufacturing, Supply Chain


AUDIENCE LEARNING LEVEL

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.


Instructors:

Anne Johnson

Anne Johnson
FDA

Anne E. Johnson is the Program Division Director of the Office of Bioresearch Monitoring Operations, Division 1 within the Office of Regulatory Affairs (ORA) in the Food and Drug Administration (FDA). She directs field inspectional operations covering FDA-regulated clinical and non-clinical research, postmarketing pharmacovigilance and select pre-approval programs designed to ensure human subject protection, evaluate data quality and integrity in product approval applications, and assess industry conformance with laws and regulations. Her division covers the eastern third of the United States, including Puerto Rico and the U.S. Virgin Islands.

She is also the District Director of FDA’s Philadelphia Office and the senior FDA representative and point of contact for the states of Pennsylvania and Delaware. In this capacity, she is responsible for liaison, emergency response and collaboration activities with other federal, state, and local agencies, while maintaining oversight for employee support and safety, and FDA facilities located within the district.

Ms. Johnson began with the FDA as an investigator and promoted to compliance officer, specializing in enforcement and regulatory follow-up in biologics, biotech drugs and biological device industries worldwide. She then became a supervisory investigator and district food monitor, advancing as Deputy District Director prior to her current positions.

Ms. Johnson is active on the speaking circuit, presenting at conferences for regulators, industry, academia, and stakeholders. She has researched and provided briefing and background information for use in preparation for congressional hearings and testimony, worked on national special security events, and overseen the execution of federal contracts. She chairs several committees and is an FDA trainer for managers and supervisors. She holds a B.A. in Chemistry, from Rutgers University.

Ingrid Zambrana

Ingrid Zambrana
FDA

Ingrid Zambrana , HAFE3 PDD began her career with Food and Drug Administration as a Consumer Safety Officer in 2000.

She’s served as the District Director (DD) of the US Food and Drug Administration Atlanta District Office since April 2014. In 2016, Ingrid Zambrana leadership responsibilities expanded to add Program Division Director aligning operationally within the Office of Human and Animal Foods Operations (OHAFO.

In her current role, she has responsibility and oversight of the district cross- operational activities to include, emergency preparedness and response, federal-state programs covering States of Georgia, North Carolina and South Carolina, special emphasis programs, and leveraging activities for the District Office which includes fostering working relationships as the senior local field official with respective HHS region office, Atlanta Federal Executive Board and other federal agencies . In her current role as Program Division Director, Ingrid has implemented business process improvements in support of an Integrated Food Safety System, increased emergency preparedness and response. Her contributions have involved the development and implementation of the operational related to the legislative authorities related to the Food Safety Modernization Act (FSMA) more specifically the Produce Safety Rule. She serves in various committees and workgroup to include the ORA Human Food Committee, Rapid Response Team Advisory Committee among others. Ingrid’s contributions to the US FDA mission to protect public health have been recognized through numerous awards and publications. Prior to joining the FDA, she proudly served in the US Army in the military medical group, stationed domestically and abroad.

Mark Rivero

Mark Rivero
FDA

Mark W. Rivero is a Compliance Officer in the Office of Pharmaceutical Quality Operations (OPQO), Division 2 within the Office of Regulatory Affairs (ORA) in the Food and Drug Administration (FDA). He specializes in the enforcement and regulatory follow-up in pharmaceutical manufacturing and compounding drug industries worldwide. His division covers the southeastern third of the United States including Puerto Rico and the U.S. Virgin Islands.

Mr. Rivero began his career with FDA as an investigator in the New Orleans District (NOL-DO) during 1990. He was promoted to Resident Investigator in Charge of the Shreveport Resident Post, overseeing investigations in all program areas in the north Louisiana. He then became a Compliance Officer in NOL-DO where he handled regulatory actions in multiple commodity programs and then reassigned to OPQO during program alignment in ORA.

Mr. Rivero serves on several committees including Southeastern Incident Command and ORA’s compounding pharmacy program. He holds a B.S. in Biology from Loyola University New Orleans.

Salvatore Randazzo

Salvatore N. Randazzo
Compliance Officer, Compliance Branch
Office of Medical Devices and Radiological Health Operations

Salvatore (Sal) Randazzo joined the FDA, Office of Regulatory Affairs (ORA), Florida District Office in 2002, as part of a new hire initiative following September 11, 2001. As an Investigator in Florida District, Sal specialized in the medical device and drug program areas where he conducted complex inspections involving high-risk products and processes. In 2009, he joined the Florida District Compliance Branch as a Compliance Officer processing cases involving medical device and drug manufacturers that were found non-compliant with Agency-enforced laws and regulations. In 2017, following ORA’s program alignment, he continued his work as a Compliance Officer in the Office of Medical Devices and Radiological Health Operations, Division 2 - Central, Compliance Branch. He also serves as Technical Expert for FDA’s AAMI Standards Workgroup 1, Industrial EO Sterilization. Sal is a recipient of the FDA Outstanding Service Award.


Cancellations

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

All cancellation requests must be submitted in writing to raps@raps.org.  RAPS is unable to accept cancellations by phone.

To transfer a registration, email raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.


Questions

For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshophttps://www.raps.org/website/virtual-event-help

For account support, contact the RAPS Support Center: +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.

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