LOGIN
Directory of Consultants
Bay Area Biomedical Consultants Network (BABCN)
Name and Educational Degree(s) Lison, Liz, BS
Business Name Advocea LLC
Certifications
Education

Liz has a BS in Medical Science from Bradford University, UK.

Business Address PO Box 1029
Mountain View, CA 94042-1029
Contact information
Telephone:
Fax:
Mobile Number:
Email address:
650 714 4696
650 887 0384
650 714 4696
lizlison@advocea.com
Specialties

Liz is an independent regulatory affairs and compliance consultant based in California.  She has over 20 years experience in the IVD industry, most recently working with early stage companies on cutting-edge diagnostics. These assignments have included working with and advising teams on the development of assay and instruments for SNP, gene expression and protein biomarker assays, including LDTs and IVDMIAs.

She is experienced in developing early stage regulatory strategy and quality system implementation for startup companies allowing them to build compliant operations and to shorten time to commercialization of their first product.  Liz has experience in implementation and compliance with ISO 13485, QSR and CLIA Quality Systems and has focused on how to integrate these various requirements into manageable systems for small companies.

Prior to setting up her own consultancy company, she was VP of Regulatory Affairs at Aviir, Director of Regulatory Affairs at XDx, VP of Operations at Naxcor and VP of Customer Service Operations at PharmChem.  She also held a number of sales and product management positions at Syva UK.

 

Experience
  • Over 15 years Quality and Regulatory experience (QSR, GCP, GLP, ISO, CLIA, SAMHSA) with 5 different companies in both the US and the UK.
  • 12 years of experience operating at Vice President or Director level in Quality and Regulatory Affairs.
  • Designed and implemented Quality Systems (QSR/ISO 13485/CLIA) in 5 different companies.
  • 7 years of direct interaction with the FDA with 3 different companies and with 4 clients as a consultant.
  • 2 years as a consultant working with more than 10 early-stage companies to develop their regulatory strategy.
  • 7 years of experience in medical device product development (Design Controls) and manufacturing operations in 5 different companies.
  • Established GMP compliant manufacturing at 3 different early-stage companies to support the commercialization of the first product.
  • Implemented GCP to support 4 multi-center (EU and US) clinical trials including IRB approval, site monitoring, adverse event reporting and data management. 
  • Extensive knowledge of FDA requirements for IVDMIA’s and various regulatory pathways to commercialization (510(k), de Novo 510(k), PMA, CLIA)
  • 13 plus years of leadership experience in Operations at 5 companies in both UK and US, including facility construction, staffing, and validation.
  • Maintained ISO, CLIA and SAMHSA certifications for 3 different companies with 6 successful inspections. Also participated in over 20 successful customer audits (government and private companies).
  • Resolved 42 deficiencies for a GLP laboratory within six month period culminating in a second inspection with only one minor observation.
  • Established HIPAA compliance in 4 different companies
Additional Consultant Information Links
Back to Directory of Consultants