Name:
Helena Margaret Champion
Country:
USA
City:
Palm Beach
State/Province:
FL
ACS Member:
Member
Local Section:
L409,South Florida
International Chapter:
Technical Division Membership:
Technical Division Membership Emeritus:
Subdivision Member:
ACS Activities:
Company/Institution Name:
Career Stage:
Professional
Research and Special Interests:
Area of Expertise:
Quality Assurance Consultant - Biotech/Pharmaceutical.
Over 20 years of U.S and international experience in pharmaceutical and biotechnology manufacturing and testing. Drug development, commercial. Audits, FDA Inspection preparation and support, Biotech/Pharma Technology Transfer, Validations.
I have wide Quality Assurance, Regulatory Compliance and product development experience in both drug substances and drug products and implementation of the new Pharmaceutical Quality System Q10 Guidance in a practical manner.
My API experience includes small molecule synthesis, cell culture and vaccines. My drug product experience includes oral liquids and tablets, inhaled and parenteral dosage forms, and aseptic processing of biotech drugs and packaging. I provide a practical approach derived from years of GMP and GLP manufacturing and hands on product and process development and analytical chemistry laboratory experience. I am expert on the regulatory requirements for good manufacturing practices for clinical development and commercial drug manufacturing and testing. I provide a dynamic and strategic approach to QA for drug development and commercialization and developing and maintaining Quality Systems.
I have extensive experience performing Quality Audits on drug substance, drug product and medical device manufacturers in the USA and throughout Europe. I led and participated in CRO/vendor qualification audits to support activities for drug development programs. Created audit plans, coordinated GMP, GLP, GCP Audits. I performed GLP audits at CRO"s, evaluated significance of audit findings, coordinated responses with CRO"s regarding preclinical testing and managed processes for noncompliance corrective action plans.
Years of Expertise:
21-25