Instructors

Martin Browning – Mr. Browning is the President and co-founder of EduQuest. He has over thirty years of FDA and regulatory experience.  He has and demonstrates extensive expertise in management consulting, FDA regulation, regulatory affairs, quality assurance, software and systems engineering, and auditing.  Specific experiences include quality systems design, system design assurance, verification and validation of production and medical systems, processes and software.  Mr. Browning is a well-known expert in FDA regulations having written or contributed to writing many during his FDA career.  He left the Food and Drug Administration in 1995 after 22 years as a local, national, and international expert Investigator and then as a Special Assistant to the Associate Commissioner for Regulatory Affairs.  While with FDA, Martin served as Vice Chair of the Electronic Record and Signature Working Group, which drafted the 21 CFR Part 11 regulations.  He also served as Chair of the U.S. Government ISO-9000 committee; on the Global Harmonization Task Force; and on the committee that developed the new medical device good manufacturing practice regulations, otherwise known as the Quality System Regulation (QSR).  He participated in the EduQuest Computer System Validation training courses presented to FDA.  Mr. Browning has an undergraduate degree in Aerospace Engineering and Political Science and a Masters Degree in Computer Science. 

Denise D. Dion – Ms. Dion is a Senior Regulatory Consultant for EduQuest and has been with the company since December 2002.  She left the Food and Drug Administration in 2002 after 18 years.  During her last eight years with FDA, she served in FDA headquarters as the medical device investigator liaison between the Office of Regulatory Affairs (ORA) and the Center for Devices and Radiological Health as well as between ORA headquarters and the field staff.  She was one of the designers, authors, and trainers of the Quality System Inspection Technique and training materials.  She served on FDA’s Design Control Inspection Strategy Team, was the editor of the Investigations Operations Manual for five years, and participated in FDA’s basic medical device and process validation training.  She was ORA’s final reviewer for on-line basic investigator training courses and worked on the development of FDA’s Risk Management and Computer System Validation on-line training courses.  Denise has performed expert-level inspections in the areas of medical devices, drugs, and biologics.  She has experience in regulatory requirements for foods, drugs, devices, biologics, clinical investigators, and institutional review boards (IRBs).  Ms. Dion has a Bachelor of Science degree in Biology and Environmental Studies and has completed post-graduate coursework in aquatic ecology, microbiology, genetics, and biochemistry.

Janis V. Olson – Mrs. Olson is a Senior Validation Consultant for EduQuest, Inc. She conducts audits of industry for compliance with FDA regulations and assists firms in interpretation of the regulations and implementation of compliant GxP systems. Industries audited include pharmaceutical, biological, biotechnological, and medical device firms; software developers (e.g., clinical trial software and blood bank system software, software driven medical device); contract laboratories; and clinical facilities including Clinical Research Organizations. She also trains and gives speeches on risk management, GxP compliance, preparation for audits, computer system validation, 21 CFR Part 11 (Electronic Records; Electronic Signatures) for Industry. Prior to EduQuest, Mrs. Olson (then Janis V. Halvorsen) worked for the U.S. Food and Drug Administration for over 22 years. Her last job was the Director of the Southeast Region’s Information Resources Management Office (SIRMO). She started in Orlando District in 1978 where she served as a general investigator and the Radiological Health and Medical Device Specialist. Her next job was a Supervisor overseeing the ANDA/NDA approval program in the Atlanta District Office and Computer Specialist making inspections of computerized systems in the US and overseas. As an investigator and supervisory investigator, Mrs. Olson conducted domestic and international inspections of FDA regulated industry including pharmaceutical, medical device, and biologics companies. As Director of SIRMO, she was responsible for providing computer (hardware and software) support as well as local and wide area network connections to the FDA Southeast Region. Mrs. Olson has been a leader in teaching computer use and computer system validation to FDA personnel since 1991. She was part of the national FDA training for Industry on Part 11 (Electronic Signatures; Electronic Records) in 1998 and 1999 including the satellite down-link in January of 1999. She has been giving presentations and training to industry on regulatory requirements, computer system validation, and 21 CFR Part 11 throughout her career. She was a member of the PDA task force that wrote the Good Electronic Records Management (GERM) document. She is certified as an ARC/PDA auditor. She was on the PDA task force that wrote Technical Report 32, Computer System Supplier Auditing and is chair of PDA’s Industry Review Board for Audit Resource Center (ARC). Mrs. Olson has a Bachelor of Science in Biology from Cornell University. She received her Masters of Science in Computer Systems (specialty in software engineering and development) from the University of Central Florida in 1992. Her interests include quality systems, risk management, computer-controlled manufacturing, software engineering, software quality assurance, and software safety. She is a member of the PDA, IEEE, and IEEE Computer Society.

Gordon B. Richman – Mr. Richman is Vice President, Strategic Compliance Consulting and General Counsel of EduQuest. He joined the company in January 2002. Mr. Richman brings a unique background and over 20 years of regulatory, legal, and corporate management experience to EduQuest, including more than 10 years in increasingly responsible senior management positions with leading pharmaceutical and medical device companies, first as Director of Worldwide Quality Strategy in GlaxoSmithKline’s Global Manufacturing and Supply operations, and then as Vice President of Regulatory Compliance at Fisher & Paykel Healthcare and Vice President of Regulatory Affairs at Masimo Corporation. Previously, he spent several years in FDA regulatory practice with major law firms in Washington, D.C., where he advised and defended pharmaceutical and medical device companies on a broad range of FDA regulatory issues, including both administrative and criminal enforcement matters. Mr. Richman has a broad base of experience in the complex, cross-functional issues faced by the FDA-regulated industries, including matters that span across Manufacturing and Supply (e.g., good manufacturing practices, internal auditing, product complaints and failure investigations, field alerts and recalls, process validation, change control, inspectional preparedness and responses, and regulatory enforcement); Research and Development (e.g., good clinical practices, good laboratory practices, adverse event reporting, medical device design, clinical data management, drug and medical device labeling, clinical protocol design, informed consent, toxicity assessments for child-resistant packaging, the inclusion of women of child-bearing potential in clinical trials, and FDA inter-center jurisdiction for combination products); and Information Technology (e.g., computer systems quality, compliance, and validation, software development, and compliance with regulatory requirements for electronic records and electronic signatures). He also has extensive experience in developing and providing training on FDA’s good practice requirements, regulatory compliance, and inspectional preparedness. Mr. Richman has a Bachelor of Science degree in Chemical Engineering (with a specialization in chemical process control) and a Juris Doctor degree.

Sharon Strause – Ms. Strause recently joined EduQuest as a full-time employee. She has been a consultant since 2004 to the LifeScience, Consumer Product, and Software Development Industries. Previous to her consulting, she had 15 years experience in the pharmaceutical field. She worked for McNeil Consumer & Specialty Pharmaceuticals, a Johnson and Johnson Company. Sharon worked for 7 years in the Quality Assurance Division managing the Quality Sciences & Compliance Document Control Group which established standards, policies and practices for documentation at McNeil and Johnson & Johnson Merck Pharmaceutical. In April 1996, she transferred to the Operations Department to take responsibility for the computer system validation on the McNeil/JJMCP SAP project. In June 1999, she transferred to the Information Management Department to become part of the CSV team at McNeil. She continued to manage the SAP work and also helped to establish Quality and Compliance in the Information Technology Department. Ms. Strause worked with the cross-functional team that developed the current standard operating procedures for Computer System Validation at McNeil. She has developed several training courses on Computer System Validation, GMP training, testing, and “train-the-trainer”. She led the SAP Validation Networking Group, which was part of the SAP America’s User Group, for 6 years. She is a member of the PDA and ASQ organizations and serves on the advisory board of the Institute of Validation Technology. She received an Industry Recognition Award from the Institute of Validation Technology in 2004.

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