Pulmonary Function Accreditation Program

Compiled new drug submissions for medical gasesDrafted, reviewed and approved validation protocols for Air Liquide Canada’s and VitalAire’s medical gas filling plants • Determination of critical elements and risk assessments• Installation Qualification, Operational Qualification, and Process Validation protocols• Validation of analytical methods • Cleaning validation • Approved executed protocolsVice-Chair VitalAire Clinical Committee• Determined national clinical standards• Reviewed marketing literature, forms and standard operating procedure impacting clinical operations Performed internal GMP compliance audits, external vendor qualification audits, and GMP compliance audits of foreign sites fabricating medical gasesPerformed Risk Analysis of new procedures and equipment for respiratory therapy.Performed regulatory watch activitiesParticipated on Technical Review Committee for VitalAire’s Industrial Management System (IMS).• Reviewed new and revised Air Liquide Group procedures for their applicability to VitalAire CanadaDeveloped infection control, clinical practice and quality system proceduresManaged medical device recallsReviewed and approved medical gas fabrication, packaging and analysis procedures.Participated in non-conformance and incident reviewMaintained currency of Equivalency Certificates (permits) for the Transportation of Dangerous GoodsAssisted regional home care offices for preparing for, and participated in, Accreditation Canada surveys for home care accreditation.