Tony Lam
Retired Regulatory & Quality Executive
- Role
- Collector Classic Cars & Motorcycles at Car & Classic
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Tony Lam
Expert in IVD Regulatory Affairs, Quality Management, Clinical Affairs and Compliance in Molecular Diagnostics, Companion diagnostics, Pharmacogenomics, Immunodiagnostics, Clinical Chemistry, Pharma, Personalized Healthcare and Lab Developed Test (LDT)Advanced Cell Diagnostics - Innovative Molecular Diagnostics with novel tissue pathology technology. Establish ISO 13485 Quality Management Systems, CE Mark Diagnostics, FDA Quality Systems Regulations and FDA diagnostics marketing requirementsQiagen - Sample and Assay Technologies - Enabler in IVD, Molecular Diagnostics, Personalized Healthcare - Companion diagnostics, Genetics, Women\'s Health - Digene HPV, Infectious Diseases, Lab Automation, Drug and Biomedical Development, Life Sciences, Precision Therapeutics - Personalized Medicine - Cellular and Genetic Diagnostics for Cancer Therapeutics Selection - Lab developed TestThermo Fisher: Diagnostic Division - IVD, Instruments and Automation, Life Sciences, Clinical Chemistry, Lab reagents and supplies
Experience
Collector Classic Cars & Motorcycles
Apr 2020 — Present · US
Education
University of Oklahoma
BS, Microbiology, Molecular Biology
UC Santa Barbara
Management and Supervision Certificate
University of California, Berkeley
Post-graduate Courses in Biology and Business. MBA Candidate
University of Oklahoma Health Campus
MS, Microbiology, Genetics and Immunology
Skills
- Medical Devices
- Capa
- Clinical Affairs
- Vaccines
- Qsr
- Validation
- Design Control
- Personalized Medicine
- Polymerase Chain Reaction (Pcr)
- Biologics
- Regulatory Affairs
- Lifesciences
- Life Sciences
- Gmp
- Regulatory and Quality Systems Compliance
- Molecular Diagnostics
- Quality Management Systems
- Biotechnology
- Ce Marking
- Medical Diagnostics
- Biomedical Engineering
- Iso 13485
- Assay Development
- Oncology
- U.s. Food and Drug Administration (Fda)
- Hardware Diagnostics
- Pcr
- Diagnose
- Fda
- Quality Assurance
- Cell
- Laboratory
- Companion Diagnostics
- Personalized Healthcare
- Lab Developed Test/Clia Lab
- Quality System
- Pharmacogenomics
- Ivd
- In Vitro Diagnostics - Ivd
- Laboratory Automation
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.