Drug Quality Assurance, LLC

Drug Quality Assurance, LLC

Helena Champion, Principal Consultant

Practical Quality support - biotechnology, pharmaceutical drug development, manufacture, testing, clinical trials, commercial

Helena Champion, Principal Consultant

Practical Quality support - biotechnology, pharmaceutical drug development, manufacture, testing, clinical trials, commercial

Quality Consulting

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Experience and knowledge

  • 30 years USA, European, UK experience pharma & biotech manufacture, testing, CMC, hands on product development
  • Helena was Quality Director at Wyeth Biotech (Pfizer), held senior positions at Biogen Idec, Genzyme, Millipore and Cambridge Isotope Labs /Otsuka
  • Wide QA, Regulatory Compliance  experience drugs, medical devices
  • Helena has Masters in Science, University of Guelph, Ontario, Canada, research, thesis development HPLC methods peptides separation 
  • MBA Northeastern University Boston
  • Worked on many Clinical development programs to commercial launch, support commercial products
  • Led over 50 Audits worldwide
  • Chemistry, Manufacturing Controls

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Quality Systems, Regulatory Compliance

  • FDA/ European/ global regulations
  • GMP, GLP, GCP 
  • Quality Agreements
  • Standard Operating Procedures SOPs
  • Risk Assessment
  • Training 
  • Prepare for Pre-Approval Inspections
  • Inspection and Warning Letter Response and follow up.
  • Consent Decree remediation, impact
  • Management controls, internal audits and performance metrics
  • Meet new FDA and ICH expectations for management responsibility

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Quality oversight of contract manufacture and testing

  • Batch Record Review, Batch Release  
  • Investigations, Corrective Action and Preventive Action
  • Technology Transfer
  • Master Batch Record development, Device History Record, procedures
  • Master Validation Plans, Process Validation Protocols /Reports, Equipment Qualification
  • Test Method Validation, analytical
  • Supply Chain Quality
  • Expert on water systems
  • Clinical diagnostic reagents 

Pharmaceutical, Biotech Expert

GMP, GLP, GCP Support for Active Pharmaceutical Ingredients (API) and Drug Products

RECENT ARTICLES, PRESENTATIONS BY HELENA:

  • Drug Quality in a Global Economy, Contract Pharma May 2014
  • New England Chapter, Parenteral Drug Association speaker. March 2013 "Pharmaceutical Supplier Quality for the 21st Century" 
  • How to Overcome Industry Challenges of More Required Audits, IVT 3rd Supplier Quality Forum Nov 2012 Philadelphia, PA
  • Keynote speaker Informa Biopharmaceutical Raw Materials Conference June 2012, Cologne, Germany 
  • Chairperson at Viral Safety for Biologics Conference 2012 Cologne

Drug Quality Assurance, LLC, Helena Champion

drugqualityassurance@gmail.com

(781) 724-6812

Boston, MA and Palm Beach, FL

  • Small molecule synthesis, cell culture, fermentation, biotechnology, biologics and vaccines 
  • Drug product - aseptic processing, parenterals, transdermal 
  • Oral liquid, tablet, inhaled dosage forms and packaging