Team Leader

Jan Warner, President IQA Consulting Services
Jan Warner, MS, MBA
President

Jan Warner is an accomplished, broad-based quality and compliance professional with over 30 years of experience in: pharmaceuticals, medical devices, OTC and  Rx drugs, active pharmaceutical ingredients (API), cosmetic ingredients, personal care, homeopathic drugs, dietary supplements and cosmetics.  He has held senior management responsibilities in quality assurance, compliance and quality control at companies such as Pall Corporation, L’Oreal, Luitpold Pharmaceuticals, Axiom Pharmaceuticals and Nobel Biocare.  Jan leads a team that serves a range of companies, including Fortune 500 companies, mid-sized firms as well as start-ups.

His expertise encompasses:

  • FDA regulated product manufacturing, packaging, Quality Assurance, Laboratory Operations and Regulatory Affairs
 
  • Creation, implementation and management of Quality Systems for the following standards: GXP, ISO 13485, ISO 22716, ISO 15378, ISO 9001, ICH Q7 and EFfCI
 
  • Manufacturing, Quality and Complaint investigations
 
  • Training, technical writing and SOP development
 
  • CAPA and change control management
 
  • FDA Field Alerts, 483s, recalls and consent decree remediation
 
  • Supplier, API, contract manufacturing and packaging, internal and third party auditing

Jan received his B.S. in Biology from SUNY Stony Brook and an MS and MBA in Management of Technology from New Jersey Institute of Technology.  He can be contacted at Jan@IQAConsulting.com.
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