Drug Quality Assurance, LLC

Drug Quality Assurance, LLC

Helena Champion, Principal Consultant

Practical Quality support for biotechnology and pharmaceutical drug development manufacturing, testing, commercialization

Helena Champion, Principal Consultant

Practical Quality support for biotechnology and pharmaceutical drug development manufacturing, testing, commercialization

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

offices near Boston, MA and Palm Beach, FL

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

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

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

Member:  Parenteral Drug Association and American Chemical Society.