Data Integrity in the COVID-19 Era and Beyond
A Three-Part FDAnews/CenterWatch Virtual Conference Series

Meet Your Facilitator

Sue Schniepp

Distinguished Fellow
Regulatory Compliance Associates

Sue Schniepp, distinguished fellow at Regulatory Compliance Associates, is a data integrity expert who has served on the board of directors of the Parenteral Drug Association, as the PDA/FDA Joint Regulatory Affairs conference chair, and as chair of the PDA’s Regulatory Affairs/Quality Advisory Board. She has also been a PDA conference presenter and was awarded PDA’s Distinguished Service Award.

Sue Schniepp will be joined by an array of data integrity experts, including policy advisors, regulatory compliance experts, and medical product consultants.


Meet Your Speakers

Cynthia Schnedar

Executive Vice President, Regulatory Compliance
Greenleaf Health, Inc.

Cynthia has more than 25 years of experience as an expert in compliance issues – including more than 20 years in leadership positions in the government. Cynthia was formerly Director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research (CDER), where she led a staff of more than 300 doctors, scientists, manufacturing experts, pharmacologists, attorneys, and administrative staff. During her time at FDA, she spearheaded efforts to protect the American public from unsafe and ineffective drug products by ensuring that companies comply with federal standards for quality and safety. Among her many duties, Cynthia advised the FDA Commissioner, the CDER Director, and other senior FDA officials on significant enforcement issues.

John Avellanet

Founder
Cerulean Associates LLC

John Avellanet is an award-winning FDA compliance expert known for his business-savvy, pragmatic advice and engaging speaking style. Mr. Avellanet was the lead author of several certification courses on Good Manufacturing Practices (GMP) and Quality System Regulation (QSR) supplier management for the US Regulatory Affairs Professional Society.

Sarah Barkow

Lead GxP External Engagement
Bristol Myers Squibb
former Lead Consumer Safety Officer and Acting Director, Manufacturing Quality Guidance and Policy Staff
CDER, FDA

Sarah Barkow, PhD is the Lead for GxP External Engagement with Bristol-Myers Squibb Company, where she plays a key role in supporting and contributing to the execution of the GxP external engagement strategy.  This includes working closely with PhRMA, BIO, IFPMA and other trade organizations and tracking regulatory and policy developments across the GxP realm. Sarah is former Lead Consumer Safety Officer and Acting Director, Manufacturing Quality Guidance and Policy Staff in FDA CDER’s Office of Compliance. At FDA, she also served as a Special Assistant to Donald Ashley in the Office of Compliance, and as Senior Policy Advisor in Compounding. Sarah was instrumental in drafting multiple guidance and policy documents including the guidance for industry on Data Integrity and Compliance with CGMP and in developing internal processes and aids.

Beverly Lorell

Senior Medical and Policy Advisor
FDA and Life Sciences Practice, King & Spalding

Beverly Lorell, MD is the Senior Medical and Policy Advisor with the King & Spalding’s FDA and Life Sciences Practice in Washington, D.C. Dr. Lorell specializes in the areas of clinical trial design of studies for drugs, devices and biologics; review of pre-market submissions; recalls; and assessment of matters involving a risk to health. She also specializes in the area of physician and industry relations and the development of independent scientific panels to advise health industries.

David Elder

Executive Vice President, Regulatory Compliance
Greenleaf Health

David Elder brings more than 30-years of extensive regulatory experience to his role as Executive Vice President for Regulatory Compliance at Greenleaf Health. A 23-year veteran of the U.S. Food and Drug Administration (FDA) and U.S. Public Health Service (USPHS), David served as a senior FDA official with prominent roles in domestic and foreign inspections, recalls and emergencies, and compliance actions involving hundreds of situations. He has testified in federal court and before Congress, initiated and approved enforcement actions, and represented the FDA during national media events. Additionally, David has received numerous honors, including the Distinguished Service Medal. David began his FDA career as an investigator in the Boston District Office where he conducted domestic and foreign inspections and investigations in various program areas. He was selected as a compliance officer and later as the director of the compliance branch with responsibility for assessment of inspection reports, initiation of compliance actions and evaluation of compliance action effectiveness. David transferred to FDA headquarters when he was selected as the director of the FDA Office of Enforcement in 2003, a position he held for the next six years. In this senior executive service position, David led the Office with responsibility for agency enforcement policy, agency recall policy and operations, and enforcement strategy and case review.

David L. Chesney, MSJ

Principal and General Manager
DL Chesney Consulting, LLC

David L. Chesney, MSJ, is the Principal and General Manager for DL Chesney Consulting, LLC, providing GMP and GCP compliance consulting and training services to clients worldwide.  He served for over 20 years as Vice President, Strategic Compliance Services for PAREXEL Consulting.  Prior to joining PAREXEL Consulting, he served 23 years with the FDA, serving as an Investigator, Supervisory Investigator, Director of Investigations and ultimately as District Director in San Francisco, managing all FDA operations in Northern California, Nevada and Hawaii.  He also served as an Evidence Development instructor for FDA at the national level. 

Mr. Chesney has a Bachelor's degree in Biology from California State University, Northridge, plus three years of graduate study in Biology at CSU Northridge and CSU San Diego, and an MS in Jurisprudence, concentrating in Pharmaceutical and Medical Device Law from Seton Hall University School of Law.  Mr. Chesney is a member of PDA, where he serves on the faculty of the Training and Research Institute.  He is also an active member of the Food and Drug Law Institute and RAPS.