2016 OMB Summer Meeting

AOAC OMB Meeting Book

110

 Revised the Corrective / Preventive Action system which added notifications to people of their responsibilities and resulted in actions being closed on time.  Hosted, managed, coordinated and participated in regulatory inspections for many regulatory bodies including FDA, Health Canada, the Medicines and Healthcare Products Regulatory Agency (UK). This resulted in many successful audits and licensing of new products.

J ANE W EITZEL

P AGE T HREE

Quality Assurance Supervisor 1998 – 2000 Performed all tasks in the Quality Assurance department, such as approving change controls, validations, performing internal audits and releasing product. Supervised 4 staff.  Implemented an improved external audit program that improved standards of the audits and allowed many suppliers to be qualified. CANGENE CORPORATION (Continued) Good Manufacturing Practices Compliance Specialist 1997 – 1998 Performed all tasks in the Quality Assurance department, such as approving change controls, validations, performing internal audits and releasing product.  Learned the cGMP requirements quickly so that backlogs in approving change controls and validations were eliminated. BIOVAIL CORPORATION , Steinbach, Manitoba 1997 Validation Chemist, Lab Analyst

Analysed routine Quality Control lab samples and validated new lab methods.  Validated methods quickly, supporting the quick launch of a new product.  Tested samples with very little rework needed resulting in timely release of product. MANITOBA MINES LAB , Winnipeg, Manitoba

1976 – 1997

Chemist Analyzed mineral samples, developed and validated new methods as needed and qualified new ICP instrument, including developing and validating test methods.

Publications

Books

Application of ISO/IEC 17025 Technical Requirements in Industrial Laboratories: Method Validation, 2013, M.L. Jane Weitzel and Dr. Wesley M. Johnson, Friesenpress http://www.friesenpress.com/bookstore/title/119734000004601536/M.L.-Jane-Weitzel-and-Wesley-M.-Johnson- Application-of-ISO/IEC-17025-Technical-Requirements-in-Industrial-Laboratories Method Validation in Pharmaceutical Analysis: A Guide to Best Practice , Chapter 3 Establishment of Measurement Requirements – Analytical Target Profile and Decision Rules , ed Dr. Joachim Ermer, Dr. Phil Nethercote, 2015, Wiley-VCH

Papers