FDA Compliance Boot Camp

Speakers

Denise DionDenise Dion

Denise Dion is a Vice President of Regulatory and Quality Services with EduQuest. She spent 18 years of her career with the FDA, where she served first as a field investigator and then as the Office of Regulatory Affairs (ORA) headquarters’ authority on agency-wide inspections and investigations. She developed many of FDA’s inspection guidance and training materials, including serving as the primary editor of the Investigations Operations Manual (IOM). In addition, she was one of the authors and trainers of the Quality System Inspection Technique (QSIT). For her EduQuest clients, Denise regularly conducts facility audits and delivers training to teach compliance with drug, medical device and biologics regulations.

Other members of the EduQuest training team include computer and compliance experts with extensive FDA experience plus decades more experience in engineering, software, quality, validation and manufacturing positions with leading FDA-regulated companies. They include:


Janis OlsonJanis V. Olson

Janis V. Olson is a Vice President of Regulatory and Quality Services with EduQuest. Previously, she worked at FDA for more than 22 years, where among other responsibilities, she conducted domestic and international inspections of FDA-regulated companies. Currently, Janis helps clients comply with GxP regulations and prepare for FDA inspections through training, writing and updating SOPs, and reviewing computer validation documentation. She has chaired PDA’s Industry Review Board for the Audit Resource Center (ARC) and was on the PDA task forces that wrote Technical Report 32 on Computer System Supplier Auditing and the Good Electronic Records Management (GERM) document. Jan is certified as an ARC/PDA auditor.


Sharon A. StrauseSharon A. Strause

Sharon A. Strause is a national authority on computer systems validation and a member of EduQuest’s global consulting and training team. She has more than 20 years of experience in the pharmaceutical and medical device fields, including seven years in the Quality Assurance Division at McNeil and Johnson & Johnson Merck Pharmaceutical.

Since 2004, she has been a consultant to the life science, consumer product, and software development industries. Previously, she worked 15 years at McNeil Consumer & Specialty Pharmaceuticals, a Johnson & Johnson Company. For seven of those years, she managed the Quality Sciences and Compliance Document Control Group that 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 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. She also worked with the cross-functional team that developed the current standard operating procedures for computer system validation at McNeil.

For six years, Sharon led the SAP Validation Networking Group, which was part of the SAP America’s User Group. She has developed several training courses on computer system validation, GMP training, testing, and “train-the-trainer”. She also is one of the co-instructors for EduQuest’s “FDA Auditing of Computerized Systems and Part 11/Annex 11” class and series of medical device quality system courses. She is a member of the PDA and ASQ organizations and serves on the advisory board of the Institute of Validation Technology (IVT). She also is the editor of the Computer Validation Forum published in the Journal of Validation Technology. Sharon received an Industry Recognition Award from IVT in 2004.


 

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