Tabitha Davis, Rac Email & Phone Number

Airdrie, Ab, Ca

Calgary, Alberta, Canada

An advocate for regulatory reform and industry maturation in the regulated product space. Responsible for developing and executing the Regulatory Strategy and associated Government Relations activities and for providing internal interpretation and guidance regarding applicable legislation and regulations.

Responsible for Sundial's regulatory relationships and licensing, directing of analytical activities, leading research initiatives, and supporting all phases of product lifecycle management.

Alberta, Canada

Alberta, Canada

Responsible for Regulatory and Compliance, including: license management, product notifications (NNCPs) and lifecycle management, quality systems, research and development, qualifications, stability and supporting programs.

Olds, Alberta, Canada

Maintain regulatory compliance and support business initiatives. Ensure activities align with regulatory requirements in an evolving industry.

Support overall facility compliance and audit readiness; responsibilities include internal audit program, CAPA system and other continuous improvement initiatives.

Assess and evaluate the current Stability programs in place for both OTC and NHP products. Maintain all aspects of the Stability Program including policies, procedures, study protocols and reports. Perform statistical analysis and trending to evaluate and interpret stability study data as per ICH Q1E and make conclusions regarding product shelf life. Apply theory from ICH Q1D to optimize the program through bracketing and matrixing where scientifically justified. Assess product and packaging changes to determine what stability studies are required to support shelf life.

Ensure compliance to HC GMP Guidelines relating to testing requirements of RMs, purchased bulks and in house manufactured FPs and assist in maintaining vendor classification programs.Review raw material specifications for compliance with evolving HC requirements for both OTC and NHP products. Maintain these specifications in compliance with current USP/Ph. Eur. requirements. Ensure that necessary raw material controls for contaminants are in present and effective to provide assurance of quality in the finished product and improve process efficiency.Assesses the impact of specification changes for additional vendor testing requirements and enforcement of Quality Agreements.Assign necessary testing and manage batch records, raw data, COAs and investigation reports.

Bachelor Of Science (Bsc)

Qa/Qc In The Pharmaceutical Industry

Cell Biology And Anatomy

High School Diploma