2016 OMB Summer Meeting

AOAC OMB Meeting Book

109

 Redesigned the Quality Systems of a Biologics company as a result of an FDA Warning Letter. This project resulted in a compliant Quality System and ensured no further regulatory action. J ANE W EITZEL P AGE T WO  Achieved registration to ISO 9001 at a pharmaceutical company in one year. This gave the company a competitive advantage and demonstrated the Quality Systems met the current standard. WORK HISTORY JANE WEITZEL CONSUTANT , Winnipeg, Manitoba 2000 – Present Consultant Consulted and trained on lab Quality Systems, both cGMP and ISO 17025, with specialization on Method Validation and the estimation and use of Measurement Uncertainty. Clients represent many industries including mining, pharmaceutical, environmental, food testing, etc. In all cases, the labs achieved ISO 17025 accreditation on the first audit enabling them to attract new business and meet requirements of both their customers and regulatory bodies.  Assessor A2LA  Auditor for Standards Council of Canada QUALITY ASSURANCE PERSON FOR MEDICAL MARIHUANA COMPANY 2014 - Present Responsible for all Quality Assurance Person duties regarding growing and selling medical marihuana in Canada Director, Laboratory Services Responsible for all activities of lab with over 70 staff to support commercial drug manufacturing, including method development, validation and routine QC testing, equipment qualification, calibration and maintenance. Also responsible for the stability program and the Annual Product Review. Managed the lab budget of over $5M.  Implemented use of Measurement Uncertainty which identified opportunity to reduce costs by $50K per month and reduce testing by 25%.  Reorganized lab documentation system and introduced use of lab worksheets with real time data review which is expected to reduce test turnaround time by 30%. WATSON LABORATORIES 2005 – 2010 Associate Director, Laboratory Operations , Corona, California 2007 – 2010 Responsible for remediation activities in response to Consent Decree. Handled all method development, validation, and transfer as well as all document control for the Lab. Oversaw Instrumentation Purchase, Qualification and Maintenance and annual budget of over $4M. Quality Assurance Manager , Salt Lake City, Utah 2005 – 2007 Responsible for Quality Assurance in the commercial and development transdermal manufacture plants and in the analytical labs  Oversaw the lot release program and redesigned the investigation process to eliminate delays in lot releases.  Improved the efficiency and effectiveness of the QA systems, by implementing a process audit program and streamlining the Batch Record Release process.  Reorganized the Quality Assurance department along function to improve GMP compliance and efficiency.  Mentored and developed staff resulting in people being promoted internally to supervisory positions. CANGENE CORPORATION , Winnipeg, Manitoba 1997 – 2005 Quality Assurance Manager 2000 – 2005 Responsible for cGMP and ISO 9001 Quality Systems in the plasma collection facilities around North America, and the plasma fractionation Manufacturing facility, including the aseptic filling line, contract manufacturing. according to the Marihuana for Medical Purposes Regulations (MMPR). VALEANT PHARMACEUTICALS INTERNATIONAL , Steinbach, Manitoba 2010 – 2011