Randy Anderson
Senior Director Quality Compliance at Chinook Therapeutics, A Novartis Company
Based in Los Angeles, United States
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Seniority
Director
Department
Engineering
Location
Los Angeles
Industry
Biotechnology Research
Company size
225
Contact information
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r•••••••@chinooktx.com
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Background
About Randy Anderson
Knowledgeable and versatile professional with extensive pharmaceutical and medical device regulatory operations experience and broad understanding of FDA programs and SOPs related to enforcement of Title 21 of US Code of Federal Regulations. Acquired Skills: Extensive work related experience with drugs, medical devices, quality and imported products. Specific work experience: Quality Systems Management oversight of electronic document management systems. CAPA deviations and resolutions, change control and direct work experience with Mastercontrol writing SOP. Hands on FDA Inspections involving cGMP, 21 CFR Part11, 21 USC 820 Quality Systems Regulations, Quality System Inspection Technique (QSIT). Knowledge of 510k, IDE and DE novo, IND, NDA and Post Market Surveillance.
Decision-makers
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Amy Edwards
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Sophia Zhang
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