Who is QIS: Representative QIS Associates
John Wiskerchen, retired from U.S. Food and Drug Administration; 1961-1998, Laboratory Director, Seattle District; 1979-1998. John now consults on behalf of FDA regulated industries including compliance and Mock FDA Inspection audits of drug and biologic manufacturing firms, drug contract labs, clinical laboratories and animal testing laboratories. He provides formal training on laboratory cGMPs, and cGLPs regulations and assists with corporate Lab OOS Investigations. As Laboratory Director with USFDA, he managed a staff of approximately 65 chemists, biologists, microbiologists, entomologists, and other lab personnel. John was awarded the Commissioners Distinguished Career Service Award, 1/99, Hammer Award, as a member of the team that developed the regulatory fish encyclopedia, 1997, FDA Group Recognition Award as a member of the Law and Evidence Development Cadre, 1993, FDA Group Recognition Award for exceptional contributions to the FDA mission in response to the discovery of widespread domoic acid contamination in seafood along the Pacific Coast, 1993, Award of Merit for the design and construction of the Seattle lab/office building, 1989 and, Commendable Service Award for co-founding the Northwest Section of the Association of Official Analytical Chemists and for the District’s research accomplishments, 1984.
Wendy Hollett, RAC, retired U.S. Food and Drug Administration; 1972-1993, Consumer Safety Office/Investigator, FDA Award of Merit recipient. After an extensive 21 year career with the FDA, Wendy worked in industry for several large medical device firms and has consulted for the past 9 years in large IVD manufacturers, pharmaceutical manufacturer and mid-size medical device companies. Her focus is performing QSR, cGMP, cGCP and cGLP audits, remediation of CAPA programs, complaint handling and MDR reporting. She enjoys QSR training and applying her practical knowledge from both an FDA and industrial background. Wendy also assists with 510(k) submissions, ISO 9000 implementation and has specialized FDA training in computer and clinical investigations and Hazard Analysis of Critical Control Points (HACCP).