AFDO Drug & Medical Products Conference

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Conference Dates

Dates: April 13-14, 2021
Location: Virtual Conference
Time: 1:00pm – 4:00pm ET Each Day

Free Registration

About the Conference

2021 continues to be a year of change and innovation on the heels of a year that required it.  This year, AFDO and the U.S. Food and Drug Administration will co-sponsor the Drug and Medical Products Virtual Educational Conference as it returns to the learning and networking event calendar. The conference will be the premier place to get updates from key regulatory leaders from the U.S., Canada, and industry in the Drug and Medical Products arena in this time of change.

The information-packed virtual event will take place in two three-hour sessions you can join at your computer on April 13 and 14 from 1:00 to 4 p.m. EDT each day. All you need to invest is your time to get the full benefit of this opportunity because the event is free. Registration is required.

AFDO members and stakeholders play a critical role in formulating law, regulations and best practices related to drugs and medical products. The annual conference is just one of the ways you can be involved. To learn more about the AFDO Drug and Medical Products Committee work or to join click here

Co-sponsorship of this event by the FDA does not imply an endorsement of the general policies, activities, or products of AFDO or any of the event’s additional sponsors.

Sponsors

Additional support for the event comes from Ceutical Labs and BioTeknia.

Agenda

Tuesday, April 13, 2021

1:00 – 1:10pm ET  Welcome and Survey of Participants

  • Steven Mandernach, Executive Director, Association of Food and Drug Officials

Session Moderator: Nancy Singer, President, Compliance-Alliance, LLC

1:10 – 1:40pm ET  FDA – Where We Are and Where We May Be Going in the Area of Drug Quality in 2021 and Beyond

  • Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, Office of Regulatory Affairs, U.S. Food and Drug Administration

1:40 – 2:10pm ET – The Opportunities and Challenges of Using Real World Evidence to Support FDA’s Regulatory Decisions in the Area of Drug, Biologics and Devices

  • John Concato, Associate Director for Real-World Evidence Analytics, Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
  • Pablo Morales, MD, Chief Medical Officer, Office of Clinical Evidence and Analysis, Center for Devices and Radiological Health, U.S. Food and Drug Administration

2:10 – 2:20  – Break

Session Moderator:  Cynthia Culmo, Principal Consultant, CC Consulting

2:20 – 2:50pm ETManaging and Preventing Drug and Device Shortages

  • Emily Thakur, R.Ph., Team Leader Drug Shortages Staff, U.S. Food and Drug Administration

2:50 – 3:20pm ET   –   Managing and Selling Medical Devices in the UK and Northern Ireland

  • Kimberly Trautman, Executive Vice President, Medical Device International Services, NSF Medical Devices

 3:20 – 3:50pm ET   –   Update on Canadian Regulation of Drugs and Medical Products

  • Mary Morgan, Director, Health Product Compliance Risk Management, Regulatory Operation Enforcement Branch, Health Canada Ottawa
  • Chad Sheehy, Acting Director, Medical Devices Compliance Program, Regulatory Operations and Enforcement Branch, Health Canada

3:50 to 4:00pm ET – Closing Remark

  • Megan Snyder, Manager, Drugs and Medical Devices, Texas Department of State Health Services, AFDO Co- Chair of Drugs, Devices & Cosmetics Committee

Wednesday, April 14, 2021

1:00 – 1:10pm ET   –   Welcome and Survey of Participants  

  • Steven Mandernach, Executive Director, Association of Food and Drug Officials

Session Moderator:  Nancy Singer, President, Compliance-Alliance, LLC

1:10 – 1:40pm ET   –    FDA Inspections and Enforcement Actions in This New Environment

  • Elizabeth Miller, Pharma.D., Assistant Commissioner for Medical Products And Tobacco Operations, Office of Regulatory Affairs, U.S. Food and Drug Administration

1:40 – 2:10pm ET –  Update on Products Coming into the United States

  • Dan Solis, Assistant Commissioner for Import Operations, U.S. Food and Drug Administration

2:10 – 2:20pm ET –   Break

Session Moderator:  Ballard Graham, Retired, U.S. Department of Food and Drug Administration

 2:20 – 2:50pm ET –   CDRH Quality Pilot – Voluntary Medical Device Manufacturing and Product Quality

  • Daniel Walter, Policy Analyst, Center for Devices and Radiological Health, Office of Product Evaluation and Quality, U.S. Department of Food and Drugs Administration

 2:50 – 3:50pm ET – Compliance/Interactive Session Get Your Questions Answered

Moderator – Julie Larsen, Principal, Director of Inspection Readiness, BioTeknica

  • Mary Morgan, Director, Health Product Compliance Risk Management, Regulatory Operation Enforcement Branch, Health Canada Ottawa
  • Dawne Hines, Division Director, Division of Northeast Imports, Office of Regulatory Affairs, U.S. Food and Drug Administration
  • Daniel Walter, Policy Analyst, Center for Devices and Radiological Health, Office of Product Evaluation and Quality, U.S. Department of Food and Drugs Administration
  • Chad Sheehy, Acting Director, Medical Devices Compliance Program, Regulatory Operations and Enforcement Branch, Health Canada
  • Armando Zamora, Senior Advisor to the Associate Commissioner for Partnerships and Policy, Office of Partnerships and Operational Policy and Acting Director for the Division of Enforcement, Office of Partnerships and Operational Policy’s Office of Strategic Planning and Operational Policy, Office of Regulatory Affairs, U.S. Food and Drug Administration

3:50 – 4:00  –   Closing Remarks

  • Mark Sestak, AFDO President, Deputy Director, Division of Food, Milk, & Lodging, Alabama Department of Public Health

Speaker Information

Alonza Cruse

Alonza Cruse is Director, Office of Pharmaceutical Quality Operations (OPQO) within the FDA Office of Regulatory Affairs (ORA).  His office is responsible for all pharmaceutical quality inspections and investigations, working in conjunction with FDA’s Center for Drug Evaluation & Research (CDER) and Center for Veterinary Medicine (CVM). Additionally, Mr. Cruse continues to lead ORA’s pharmaceutical collaboration efforts under the program alignment initiative. 

From 2013 – 2015 Mr. Cruse served as the Director (Acting) of the Office of Medical Products & Tobacco Operations (OMPTO) within ORA, overseeing activities such as Generic Drug User Fee Amendments (GDUFA) implementation, pharmacy compounding, and the development of a New Inspection Protocols Program (NIPP).  From 2000 – 2015, Mr. Cruse was the Director, FDA’s Los Angeles District Office, where his responsibilities included providing executive leadership to implementing, managing and evaluating FDA’s regulatory operations. Mr. Cruse first joined ORA in 1983 as a microbiologist.  He received his Bachelor of Science degree in Medical Technology from York College (City University of New York).

John Cancato

John Concato is the Associate Director for Real-Word Evidence Analytics in the Office of Medical Policy (OMP) at the Center for Drug Evaluation and Research (CDER), US Food and Drug Administration. In seeking to enhance policies related to drug development and regulatory review, his responsibilities involve coordinating CDER’s real-world evidence (RWE) Program, serving as Chair of the RWE Subcommittee, supporting RWE guidance development and demonstration projects, interacting with external stakeholders regarding RWE, and developing internal Agency processes related to RWE. He also supports other activities and initiatives in the Office of Medical Policy Initiatives (OMPI). Prior to joining FDA in 2019, his career focused on generating research as an independent investigator and research center director at Yale University School of Medicine and the U.S. Department of Veterans Affairs (VA), including serving as one of two founding principal investigators of the VA Million Veteran Program. He received M.D. and M.S. degrees from New York University and an M.P.H. degree from Yale University.

Dawne Hines

Dawne Hines became the Division Director of the Division of Northeast Imports on February 18, 2018.  She is responsible for the investigations and compliance staff who ensure that the FDA regulated products entering the country through the airports, seaports, and International Mail Facilities from Maine to Virginia are in compliance with FDA regulations.

Ms. Hines became the Director of Investigations Branch for the Division of Northeast Imports in May 2017 following the standup of FDA’s Program Alignment initiative: FDA Program Alignment  

From March 2017 until the standup of Program Alignment, Ms. Hines was the Director of Import Operations Branch (Downstate) of New York District, responsible for the oversight of the investigational staff at the New York and New Jersey airports and seaports.

From May 2012 until March 2017, Ms. Hines was the Director of Investigations Branch for the Atlanta District located in College Park, GA responsible for the oversight of all inspectional activities throughout the states of North Carolina, South Carolina, and Georgia, including both domestic and import operations.  There she established and strengthened relationships with various Partner Government Agencies, Port Authorities, and State counterparts to improve communication and collaboration.

In 2008, Ms. Hines was a Supervisory Investigator in Miami and then in Port Everglades in 2009 with the Florida District.  There she supervised the Miami International Mail Facility, the opening of the Port Everglades Resident Post, and the construction of the Port Everglades Screening Station.  She led a team of ten investigators, and she worked closely with CBP at Port Everglades to develop a joint tailgate and CES inspection procedure to maximize limited government inspectional resources.   

Ms. Hines began her FDA career in 2002 in Miami as an Investigator.  She gained knowledge and skills in the following areas: import field examinations; sample collections; filer evaluations; seafood and juice HACCP; international mail examinations; and entry review of processed foods, drugs, medical devices, cosmetics, and biologics.


Ms. Hines holds a BS in Biology and a BA in Spanish from Dickinson College in Carlisle, PA.  She also obtained a Lean Six Sigma Green Belt from Villanova University.  Prior to joining FDA, Ms. Hines was a high school Spanish teacher.

Kim Trautman

EXPERIENCE

Kimberly A. Trautman is an experienced Medical Devices and InVitro Diagnostics Executive Vice President with over 30 years of experience. She worked at the US Food and Drug Administration (FDA) for 24 years and continues to work with Regulatory Agencies around the globe. Industry experience as well as regulatory agency experience. Demonstrated history of working collaboratively with industry, regulators and patient groups for the betterment of public health. Executes several medical device regulatory services and developed a formal Education/Training business. Established an Authorized Medical Device Single Audit Program (MDSAP) Auditing Organization and a new Notified Body for EU IVDR/MDR Designation.

Expert in global medical device regulations, wrote and harmonized the current US FDA Quality System Regulation and was on the international authoring group of ISO 13485 since inception. Conceived and developed the Medical Device Single Audit Program and its consortium of five Global Regulators. Twenty-year veteran of the Global Harmonization Tasks Force (GHTF) and foundational member of the International Medical Device Regulators Forum (IMDRF). Recognized International Medical Device expert with a Master’s Degree in Biomedical Engineering.

EDUCATION

M.S. of Biomedical & Medical Engineering, University of Virginia, Charlottesville, VA

B.Sc. of Molecular Cell Biology and Engineering Sciences, Pennsylvania State University, State College, PA

Elizabeth Miller

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Dr. Elizabeth Miller recently rejoined the US FDA in March 2020.  In her role as the Assistant Commissioner for Medical Products and Tobacco Operations, Dr. Miller provides leadership and managerial direction to ORA’s Office of Biologics Products Operations, Office of Pharmaceutical Quality Operations, Office of Medical Device and Radiological Health Operations, Office of Bioresearch Monitoring Operations, and the Tobacco Operations Staff.

Dr. Miller comes returns from the U.S. Pharmacopeia (USP) where she helped guide USP’s working relationship with the FDA.  At USP, Dr. Miller was vice president, US Public Policy & Regulatory Affairs, with responsibility to deliver executive leadership for developing and achieving USP’s US regulatory science and intelligence, government affairs, and public policy programs’ goals. She also created strategic change focused on impacts and results resulting from engagement with federal, state, and international regulators, as well as senior leadership in industry, academia, and patient-focused alliances.

Before rejoining USP in 2016, Dr. Miller began her federal career with FDA’s Center for Drug Evaluation and Research (CDER) in 2007 in the Office of Unapproved Drugs and Labeling Compliance (OUDLC).  She began her CDER career working on online pharmacy and health fraud issues, and ultimately served as the director for OUDLC’s Division of Nonprescription Drugs & Health Fraud.

Prior to federal service, Dr. Miller worked at USP as a scientific liaison on medication safety standards for nomenclature, labelling, and packaging, and as the director of drug information for the USP Drug Information publication.  She started her pharmacy career working as a clinical pharmacist at MedStar Washington Hospital Center in Washington D.C.

Dr. Miller holds a bachelor’s degree in biology from The Johns Hopkins University and received her Doctor of Pharmacy degree from the University of Maryland.

Pablo Morales

Pablo Morales, MD, is the Chief Medical Officer in the Office of Clinical Evidence and Analysis in the Center for Devices and Radiological Health (CDRH) at FDA. Dr. Morales received his MD from Universidad Pontificia Bolivariana, Colombia, South America. He trained in vascular and endovascular surgery at Guy’s and St Thomas’ Hospital in London, UK, where he also completed a research fellowship in interventional radiology.  He joined the FDA as a medical officer in 2008, after working in endovascular research at the Cleveland Clinic for two years. He serves as the clinical authority in providing support to FDA device specific offices in reviewing and evaluating clinical and research findings, real-world clinical evidence, analyses, laboratory and clinical behavior, and the impact of these factors and properties on the safety and effectiveness of medical devices.

Mary Morgan

Mary Morgan is currently the Director of Health Product Compliance & Risk Management at Health Canada. Mary oversees the compliance and enforcement activities across Canada for prescription drugs, over the counter drugs and natural health products both domestically and at the border. Mary has been with Health Canada for approximately 18 years and held various regulatory, policy and operational roles across the organization in both pre-market and post-market environment. Mary completed a Master of Public Health from the University of Massachusetts and Bachelor of Science at the University of Ottawa.

Chad Sheehy

Chad Sheehy is the Acting Director of the Medical Devices Compliance Program of the Regulatory Operations and Enforcement Branch at Health Canada. He is responsible for Medical Device Establishment Licencing, Inspection, Compliance Monitoring and Enforcement. Chad has over 15 years experience in compliance and enforcement with Health Canada in the areas of pharmaceutical good manufacturing practices (GMP), clinical trials (GCP), blood, cells/tissues/organs, medical devices, assisted human reproduction and pharmacovigilance. He has represented Canada at the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and has worked collaboratively with international regulators in Europe, Asia, Australia, Africa and with the US to harmonize regulatory systems and practices.

Chad holds a Bachelor of Science Degree from Dalhousie University and a Doctor of Naturopathic Medicine (ND) from the Canadian College of Naturopathic Medicine. He is based in Calgary, Alberta.

Dan Solis

Biography: Dan Solis, MHA
Mr. Solis is a recognized expert in FDA import operations who has served as the acting assistant
commissioner and director of ORA’s Office of Enforcement and Import Operations (OEIO) since
March 29, 2020. During this time, he has provided leadership and direction to all OEIO field
import divisions as well as the Division of Food Defense Targeting and Division of Import
Operations at FDA HQ. He brought about the leadership and stability needed during the
COVID-19 Pandemic. Mr. Solis was selected as the Assistant Commissioner for Import
Operations on November 22, 2020 and prior to that he was the Division Director for the Division
of West Coast Imports since February 9, 2018.


He started his career with FDA in 1998. Prior to working in FDA, Mr. Solis worked in the
Bioresearch field focusing on Medical Device and Drug Application Products after graduating
from the University California of Irvine and the University of La Verne. Mr. Solis has held many
positions within FDA that includes working at the FDA lab in Irvine, Ca. as a Microbiologist,
HQ position within the Division of Import Operations in Rockville, MD, working as an Import
Compliance Officer and working in the FDA Los Angeles District Office as a Director of Import
Operations Branch.


Mr. Solis is an experienced collaborator who has played an integral role in FDA operational
activities with other federal agencies, partnering with Customs and Border Protection,
Homeland Security Investigations, U.S. Department of Agriculture, U.S. Fish and Wildlife
Service, Drug Enforcement Agency, and state and local law enforcement agencies. Additionally,
he conducts local and national training on imports, is a member of the National Leadership
Development Workgroup at FDA’s Office of Training and Education Development, and has
served as a mentor for the Federal Executive Board in Los Angeles and ORA’s Potential
Supervisors Program.
In his new role, Mr. Solis serves as the principal advisor to Associate Commissioner for
Regulatory Affairs and report to the Deputy Associate Commissioner for Regulatory Affairs
(DACRA) on all import matters. This includes providing direction and oversight to FDA field
import operations, reviewing prior notice and intelligence data on human and animal food, and
leading the development and implementation of new import programs and procedures.


Mr. Solis has had many accomplishments within FDA and these are a few notables:
Implementation of PREDICT at all ports in the US, the implementation of electronic
communications and paperless transactions initiatives with the Trade Associations, formation of
the CBP/FDA Teams including the Opioid Task Force, formation of the West Coast Import
Advisory Council, formation of Federal and State Task Forces, conducting Federal Operations,
streamlining the refusal process in the Ports of LA, San Francisco and Seattle, and development
of strong partnerships with the filers, brokers and importers in the Pacific Region.


Mr. Solis is nationally recognized as a subject matter expert in the program area of Import
Operations and gives local, as well as, national training on Imports Investigations. He is a
member of the National Leadership Development Workgroup at FDA’s Office of Training and
Education Development, has served as a mentor for the Federal Executive Board in Los Angeles
and the Potential Supervisor Program within FDA. He also has had integral roles in FDA
Operations with other Federal Agencies, working with CBP, HSI, USDA, FWS, DEA and State
and local law enforcement agencies. Currently, aside from his duties at the port, Mr. Solis is also
a member of the FSMA – Foreign Supplier Verification Program (FSVP) Implementation Team
as well as the Associate Commissioner’s IT Advisory Workgroup, the Associate Commissioner’s
Import Advisory Panel, member of AFDO, WAFDO, ASQ, OCRA and the Pacific Island Health
Officers Association (PIHOA).

Mr. Solis holds a Masters Degree (MS) in Healthcare Administration from the University of
LaVerne and a Bachelor’s Degree (BS) from University California of Irvine.

Emily Thakur

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Daniel Walter

Daniel Walter has recently joined the Compliance and Quality Staff in the Office of Product Evaluation and Quality’s Immediate Office within the Center for Devices and Radiological Health (CDRH), FDA, as a member of the Case for Quality. The Case for Quality is an ongoing strategic priority for CDRH to improve access and outcomes for patients and improve device quality by engaging industry, payers, providers, and patients to focus on the quality and performance of medical devices.

Daniel began his career at FDA as a compliance officer in, then was promoted to the branch chief of, the Vascular and Circulatory Support Branch in the Office of Compliance at CDRH. In subsequent organizations, he was the chief of the Foreign Enforcement Branch in the Division of International Compliance Operations. Daniel’s branches oversaw the compliance efforts for medical device manufacturers, including inspection review, recall classification, and administration of allegation of regulatory misconduct, as well as assisting the office, Center, and Agency for cross-cutting initiatives, for most device types.
Following CDRH’s reorganization to the TPLC model, Daniel was the Assistant Director of the Obesity and Hepatobiliary Team in the Office of Health Technology 3. Daniel worked with reviewers, clinicians, epidemiologists and Medical Device Reporting analysts, to develop cross-cutting mechanisms to enhance patient outcomes through information sharing by developing “benefit-risk” based evaluation processes, in addition to reviews of regulatory submissions.
Prior to working with FDA, Daniel was a Validation Engineer, which lead to becoming a Lead Quality Auditor and Director of Quality for several contractors in the pharmaceutical industry. Daniel’s experience includes facility, utility, equipment, and process validations for automated and non-automated systems, including for steam and compressed air distribution validations, cleaning validations, and self-contained automated manufacturing lines.

Armando Zamora

Armando Zamora is currently serving as the Senior Advisor to the Associate Commissioner for Partnerships and Policy (OPOP) assuming the position on December 2019. From March to November 2019, he served as the Acting Deputy Director in OPOP’s Office of Strategic Planning and Operational Policy (OSPOP). Prior to transferring to OPOP/OSPOP, Armando was the Deputy Director for the Office of Enforcement and Import Operations (OEIO) and held the position from January 2011 to February 2019. Armando joined the Office of Regulatory Affairs in April 2008 where he served as the Team Leader for the Recall Operation Staff within OEIO (formerly, the Office of Enforcement). Armando came to ORA from the Division of Case Management, Office of Compliance and Biologics Quality, at the Center for Biologics Evaluation and Research (CBER) where he began his FDA career as a Consumer Safety Officer in June 1993. Prior to joining FDA, Armando worked at the Washington Hospital Center, Washington, D.C., as a medical technologist in the clinical laboratory’s Immunohematology department. Armando earned his Bachelor of Science degree at Towson State University, Towson, Maryland, where he disciplined in chemistry, biology, and the health sciences and holds aBoard of Certification from the American Society for Clinical Pathology (ASCP).

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