2016 OMB Summer Meeting

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 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.
JANE WEITZEL PAGE THREE
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
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
AOAC OMB Meeting Book 110