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.

Steve Lynn

Principal Consultant/Owner
Lynn Consulting

Steve Lynn has more 20 years of quality and regulatory compliance related experience in the pharmaceutical, biopharmaceutical, medical device, blood, plasma and tissue industries. He served in executive leadership roles with global accountability in both the private sector, as well as at the FDA. Steve is an expert in cGMP compliance related matters and has significant experience with other GxP quality compliance and regulatory issues. Steve is currently the principal consultant/owner for Lynn Consulting, LLC, which provides expert GxP consulting services to the life sciences industry.

Michael J. Gregor

President and CEO
Compliance Gurus

Michael J. Gregor is the President and CEO of Compliance Gurus, a premier FDA compliance consulting firm. Prior to forming his own company, Michael acquired more 25 years of experience in the FDA regulated industry. His areas of compliance expertise include: medical devices, biological, OTC and pharmaceutical drugs, cosmetics, dietary supplements, tobacco and foods. Specifically, Michael is an expert with 21 CFR Part 11 compliance and has been actively interpreting, applying, and implementing the rule since it came out in 1997. Recently, Mr. Gregor was engaged by the FDA to serve as an Part 11 expert during their routine inspections for medical device companies.

Seyed Khorashahi

Executive VP of Medical Device and CTO
Regulatory Compliance Associates, Inc.

Seyed Khorashahi has more than 25 years’ experience leading R&D teams in all aspects of developing safety critical medical devices. He has held leadership positions at Covidien (Medtronic), Baxter, and Beckman Coulter, Inc., and has an extensive background in medical device product development, quality systems, regulatory affairs, and mergers and acquisitions. Other core competencies include engineering and business strategy. Returning to Regulatory Compliance Associates® Inc. in 2015 as COO, he works in conjunction with the CEO and the Board of Directors to define operational and technical strategy for RCA, as well as plan and develop the primary processes that support the delivery of RCA client services. Previously, Seyed served as a Director, R&D with Covidien. Prior to Covidien, he was RCA’s Director of Software Systems where he led teams to perform technical due diligence projects and for multiple implementations of medical device quality systems compliant with ISO 13485 and FDA Quality System Regulation (QSR). He was also responsible for design history file remediation for legacy products and led the assessments of product development to identify technical and regulatory gaps and recommended solutions.

Deborah Fizz

Principal Consultant & Project Manager
Validation Services, LLC

Deborah L. Fizz specializes in Regulatory and Quality System activities within the health care manufacturing industries. Ms. Fizz has functioned as Acting Directors of Quality Assurance, of Regulatory Affairs, and of Validation and Compliance. She has performed remediation activities for companies under judicial action by a regulatory agency, actively participating in eleven such cases. She conducts quality audits and regulatory assessments in the biologics, biotechnology, compounding pharmacy, contract and research manufacturing, cosmetic, dietary supplements, medical device, and pharmaceutical industries both domestically and internationally in accordance with the GMPs (Chinese, Health Canada, EU, Japanese, and US), ICH Guidelines, and ISO Standards. Ms. Fizz has a diversified background, spanning a 27+ year career that started in Research & Development as a Scientist for a world premier chemical and pharmaceutical company.

Richard F. Lindauer

Principal
Lindauer Analytichem, LLC

Richard F. Lindauer, PhD, specializes in pharmaceutical quality and analytical chemistry and has consulted on numerous pharmaceutical projects during the past 20 years as Principal of his own company. He is an expert on laboratory management, analytical method validation and development, OOS and deviation investigations, root cause analysis, CAPAs, technical writing, statistics, and batch-record review. He directed USP and Pfizer analytical and research laboratories for 20 years, with primary emphasis on developing analytical methods, testing reference standards, and solving production problems. Dr. Lindauer took his Doctor of Philosophy from the Polytechnic Institute of New York, with specializations in synthetic organic chemistry and analytical chemistry. He is an emeritus member of the American Chemical Society and was a Charter Member of the American Association of Pharmaceutical Scientists. He has authored or co-authored 22 papers (including five in refereed journals), 21 posters, and 24 lectures on pharmaceutical analytical methods, stability studies, and synthetic organic chemistry.

Kalah Auchincloss, J.D., M.P.H.

Senior Vice President, Regulatory Compliance and Deputy General Counsel
FDA

Kalah has more than a decade of food and drug legal, policy, and regulatory experience at the FDA, on Capitol Hill, and in the private sector. Kalah spent six years at FDA, most recently, as Deputy Chief of Staff for two FDA Commissioners: Dr. Robert Califf and Dr. Scott Gottlieb. As Deputy Chief of Staff, Kalah worked with senior FDA leadership to manage crises, develop policy decisions, implement communications strategies, and liaise with the Department of Health and Human Services, the White House, and other agencies. Kalah was also a primary point of contact in the immediate Office of the Commissioner for the six FDA Centers and other components of the Commissioner’s Office.

Prior to that role, Kalah spent time on Capitol Hill as the FDA detailee to the Senate Committee on Health, Education, Labor, and Pensions, working on the 21st Century Cures Act and other FDA-related legislation. She has also served in FDA’s Center for Drug Evaluation and Research (CDER) as a regulatory counsel in the Office of Regulatory Policy, and as Director of CDER’s Office of Unapproved Drugs and Labeling Compliance in the Office of Compliance, leading a team of more than 50 staff working on pharmacy compounding, unapproved drugs, over-the-counter drugs, and other enforcement issues.

Before joining FDA, Kalah was an associate at the law firm Foley Hoag LLP, in the firm’s health care practice group.
Kalah holds a B.A. with honors from Williams College, a J.D. with honors from Georgetown University Law Center, and an M.P.H. from Harvard University.