Lead Quality Systems and Compliance Consultant, King and Spalding LLP
Steve Niedelman serves as lead quality systems and compliance consultant to the FDA & Life Sciences practice team at King & Spalding, specializing in regulatory, enforcement and policy matters. He provides strategic advice, insight and guidance to the medical device, pharmaceutical, biologics and food industries to ensure FDA compliance. Steve retired from the FDA in 2006 after a 34-year distinguished career, where he served as the Deputy Associate Commissioner for Regulatory Affairs and as chief operating officer of the Office of Regulatory Affairs. He ensured consistent interpretation of FDA’s regulatory policies by directly overseeing offices at the headquarters of ORA, including the Office of Regional Operations, Office of Enforcement and Office of Criminal Investigations. Additionally, Steve assisted in the day-to-day management of FDA’s nearly 3,400 field staff responsible for investigative and laboratory operations. While at ORA, Steve served as the principle liaison to the CDRH, and was a member of the GHTF Steering Committee, FDA/Medical Device Industry Grassroots Initiative Steering Committee and the CDRH Post Market Initiative Steering Committee. He also served on the Steering Committee to the Pharmaceutical cGMP for the 21st Century initiative as well the Counterfeit Drug Task Force. Prior to joining the Office of the Associate Commissioner, he was the director and deputy director of FDA’s Office of Enforcement, where he was responsible for oversight and consistency of compliance policy, enforcement and recall activities. Steve currently participates as a member of the Medical Devices Committee at FDLI and as a member of the editorial review boards for FDAnews’ GMP publications.
David A. Borasky
Vice President of IRB Compliance, WIRB-Copernicus Group (WCG)
David A. Borasky Jr. serves as Vice President of IRB Compliance for the WIRB-Copernicus Group (WCG). In this role he is responsible for leading the quality and compliance activities for all of the WCG institutional review boards (IRBs). Borasky has 20 years of experience in managing IRBs in settings that include global public health organizations, large academic medical centers, and independent IRBs. He has facilitated training activities on basic research ethics and IRB operations and management for IRB staff and members for institutions and IRBs throughout the US and abroad. He has served as a consultant for the Office for Human Research Protections, the US Department of Energy, the World Health Organization, and numerous other institutions. He currently serves as co-chair of the Subpart A Subcommittee of the DHHS Secretary’s Advisory Committee on Human Research Protections. Borasky is a Certified IRB Professional and former member of the board of directors of Public Responsibility in Medicine and Research (PRIM&R). In 2018 he was named a Distinguished Leader of PRIM&R. He received his undergraduate education at Le Moyne College and his master’s degree in public health leadership from the University of North Carolina at Chapel Hill.
Executive Director of Medical Device Education and Training, International MDSAP Team Lead, NSF Health Sciences
Robert (Rob) Ruff joined NSF International as the Executive Director of Medical Device Education and Training in December 2017. Rob has over 30 years of experience in the medical device and public health sectors. Prior to joining NSF International, Rob worked in the orthopedic device manufacturing industry and completed a long, distinguished career with the US FDA. Rob was a highly regarded district Medical Device Specialist and Senior Investigator in FDA’s Office of Regulatory Affairs (ORA), where he conducted investigations for a broad range of device technologies. During this time, he was a member of the ORA Medical Device Investigator Certification Board, where he co-developed ORA’s Level II medical device investigator certification program. From ORA, Rob was recruited by FDA’s Center for Devices and Radiological Health to lead an international team of subject matter experts tasked with the development, implementation, and maintenance of the Medical Device Single Audit Program (MDSAP). Rob’s in-depth knowledge of the MDSAP now serves as a valuable asset to NSF clients marketing products around the globe. Rob’s extensive regulatory experience includes co-authoring the MDSAP Audit Model and the Quality System Inspection Technique (QSIT). Training has been a hallmark of Rob’s distinguished career, having developed FDA’s computer-based training for QSIT, the Quality System Regulation, and the Medical Device Reporting Regulation. Mr. Ruff received many awards for his honorable service with the FDA.
Fellow, Regulatory Compliance Associates, Inc.
Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. As a pharmaceutical quality assurance thought leader with 35 years’ experience, Sue has held leadership roles in industry at Allergy Laboratories, Inc., OsoBio Pharmaceuticals, LLC, Searle, Abbott and Hospira. She is a member of the PDA Board of Directors, and has served as PDA / FDA Joint Regulatory Affairs Conference Chair, conference presenter, and chair of the PDA’s Regulatory Affairs / Quality Advisory Board. Sue was awarded PDA’s Distinguished Service Award in 2008.
PRECONFERENCE WORKSHOP LEADERS
Managing Director and Principal, Cerulean Associates LLC
John Avellanet is the author of Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine (2010, Logos Press), and founder of the FDA compliance consulting firm, Cerulean Associates LLC. Prior to founding Cerulean, John was a former Fortune 500 combination device C-level executive who created, developed, and ran his company’s compliance programs to achieve ISO, FDA, DEA, and HIPAA compliance. During his career, he had to defend decisions to inspectors, auditors, and litigators alike. John is also an expert member of the ISPE Data Integrity Working Group. He now brings that real-world experience and practical advice to his consulting clients, his articles, and his speeches.
Susan Leister, PhD
Vice-President of Quality & Compliance of Technical Resources International
Dr. Susan Leister, Vice-President of Quality & Compliance of Technical Resources International, boasts 20-plus years of industry experience and holds CQA and CSSBB certifications from American Society for Quality. She serves on the ASQ Section 509 Executive Committee and served as a 2012 and 2013 Maryland Performance Excellence Award Examiner and a 2013 ASQ International Team Excellence Award Judge. She has served as a part-time faculty member of the University of Phoenix Undergraduate and Graduate School of Business for the past five years.
President, Ombu Enterprises LLC
Dan O’Leary has more than 30 years of experience in quality, operations, and program management in regulated industries, including aviation, defense, medical devices, and clinical labs. Dan is now president of Ombu Enterprises LLC, a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. He has a Master’s degree in Mathematics; is an ASQ-certified biomedical auditor, quality auditor, quality engineer, reliability engineer, and Six Sigma Black Belt; and is certified by APICS in resource management.