2016 OMB Summer Meeting

AOAC OMB Meeting Book

108

J ANE W EITZEL 15 Park Royal Bay Winnipeg, MB R3P 1P2 mljweitzel@msn.com

Home: 204.488.2168

Cell: 204.298.3014

SUMMARY OF QUALIFICATIONS Over 35 years experience in analytical chemistry in highly regulated, fast paced companies with the last 5 years at the director/associate director level. Expertise includes managing labs compliant with ISO/IEC 17025, cGMP, and ALACC; use of measurement uncertainty; and improving lab system efficiency. Analytical decision maker with excellent people skills. Internationally recognized expert in laboratory management systems and lab accreditation.  Appointed to USP Expert Committee on Statistics for 2015 to 2020 cycle  Appointed to USP Expert Committee on Reference Standards for 2010 to 2015 cycle.  Past Chair of “Analytical Laboratory Accreditation Criteria Committee” of AOAC International. This committee publishes “ AOAC INTERNATIONAL Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food and Pharmaceuticals ”, the criteria that are used to assess laboratories for ISO 17025 accreditation.  Lead Auditor for Standards Council of Canada and A2LA for accreditation to ISO 17025 and ISO 17043.  Member of AOAC Statistics Committee. PROFESSIONAL EXPERIENCE Trainer and Consultant Provided training and presentations to both the United States Pharmacopiea (USP) and FDA on many aspects of Quality systems, specifically the use of Measurement Uncertainty to demonstrate compliance with specifications. This resulted in my being invited by the FDA to speak about the use of Measurement Uncertainty at the FDA’s Second International Analytical Methods conference in February 2011.  Wrote and maintained International Standards for lab accreditation.  Created and revised several international standards for accrediting laboratories. As a result labs around the world are using these standards in many industries.  Assisted in creating the Standards Council of Canada PALACN 1579 guide “Requirements for the Accreditation of Mineral Analysis Testing Laboratories” . This guide has been used for over 15 years now to accredit labs in countries such as Russia, Peru, Mexico, US, and Canada.  Responsible for Quality Systems to support lab operations and manufacturing operations.  Experienced in implementing, maintaining, and improving compliance with cGMP regulations of many regulatory bodies including US FDA, Health Canada, UK MHRA and others in drug and biologics manufacturing facilities.  Managed and mentored people effectively, enabling them to work at their potential and to develop self- directed teams, resulting in efficient work structures.  Learned new technologies quickly and worked with R & D scientists in order to apply Quality Systems in a wide variety of technical and scientific businesses such as transdermal manufacturing, solid dosage manufacturing, plasma collection, plasma fractionation, contract manufacturing, and the mining and environmental industries.  Changed Quality Systems in response to regulatory actions such as Warning Letters and Consent Decrees.  Led a project in response to an FDA consent decree to validate over 200 methods to today’s standards while maintaining normal lab operations and ensuring compliance with regulatory requirements. This resulted in all methods being validated to current standards, meeting a key requirement of the consent Decree.  Appointed to Chinese NIFDC Reference Standards Committee 2013 - 2016  Member of USP Expert Panel on Method Validation and Verification.