BME416-2009-1-CatharineStrom-Supplemental

BME416-2009-1-CatharineStrom-Supplemental - Careers in...

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Unformatted text preview: Careers in Regulatory Careers in Regulatory Science with an Engineering Degree Catharine Strom Outline Outline My Background Benefits of Careers in Regulatory Science How I got interested in Regulatory Science How I used my engineering degree to progress my career Other regulatory careers where an engineering degree is beneficial – – – – – Patent Attorney FDA Inspector Regulatory Compliance Specialist Document Control Specialist Quality Assurance Specialist My Background My Background BS in Biomedical Engineering MS in Regulatory Science Regulatory Affairs Manager at Corepharma LLC­ generic pharmaceutical company Regulatory Affairs CMC Specialist at Allergan Inc­ brand pharmaceuticals Benefits of a Career in Benefits of a Career in Regulatory Variety Growth opportunities Visibility Resistant to outsourcing Growing industry How Did I Get Interested in How Did I Get Interested in Regulatory Affairs? BME 416!! How I used my engineering How I used my engineering degree to progress my career Introduction to regulatory science Enhanced critical thinking and problem solving skills Technical knowledge to understand – Product development – Manufacturing procedure – Test procedure – Validation procedures Regulatory Affairs CMC Regulatory Affairs CMC Specialist Responsible for maintaining current regulatory status for chemistry, manufacturing and controls section of global dossiers Technical knowledge to review protocols and reports to ensure compliance with regulatory requirements Technical knowledge to assess regulatory impact of CMC changes Technical writing skills Patent Attorney Patent Attorney Attorney who specializes in preparing, filing, defending and challenging patents Technical knowledge on a wide range of topics Critical thinking skills to assess patents Technical writing ability FDA Site Inspector FDA Site Inspector Inspect manufacturing site for compliance with current Good Manufacturing Practices Technical knowledge of equipment and analytical procedures Scientific thinking to identify weaknesses in procedures Attention to details Regulatory Compliance Regulatory Compliance Specialist Manage supplier and internal xGMP inspections. Leads FDA and customer xGMP inspections Many of the same qualities as FDA Inspector Ability to answer questions concise and clearly Document Control Document Control Specialist Coordinate the change control system including the creation, revision, approval distribution and control of controlled documents Attention to detail Ability to follow procedures Ability to prioritize and multi­task Quality Assurance Quality Assurance Specialist Ensures products are consistently produced and controlled to quality standards. Determines root cause of out of specifications and deviations and develops corrective action plans Critical thinking skills to develop scientific methodology to identify problems Attention to details Technical knowledge of manufacturing processes and analytical procedures ...
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This note was uploaded on 06/08/2009 for the course BME 416 taught by Professor Loeb during the Spring '08 term at USC.

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