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Helena Champion, MS, MBA

DRUG QUALITY ASSURANCE, LLC

 

Member profile details

Photo
First name
Helena
Last name
Champion, MS, MBA
Organization
DRUG QUALITY ASSURANCE, LLC
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Contact information

City
Winchester
State or Province
Massachusetts
Zip Code
01890
Country
United States
Phone
(781) 724-6812
 

Specialties and Services

Fields of Expertise
  • Analytical
  • Biochemistry
  • Biotechnology
  • High Performance Liquid Chromatography
  • Licensing and Technology Transfer
  • Manufacturing
  • Pharmaceutical
  • Product Development
  • Quality
  • Regulatory Affairs
  • Separations and Purification
  • Synthesis
  • Technical
  • Technology Transfer
  • Validation
Other Fields of Expertise
Drug Development.
Pharmaceutical Manufacturing
Aseptic Fill and Finish, Sterile Processing
API Manufacturing (cell culture, fermentation, small molecule synthesis)
Medical Device.
Clinical Diagnostic reagents and calibrants.
Quality and Regulatory Compliance support of Contract Manufacturing
Summary
Principal Consultant
DRUG QUALITY ASSURANCE, LLC

Offices in Winchester, MA, near Boston and Cambridge, MA and in Palm Beach, FL.

Practical, efficient Quality Assurance and Regulatory Compliance support for manufacturing, testing pharmaceuticals, drug development and medical device development and commercialization. Expert on FDA and global current Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) regulations.
Services
QUALITY ASSURANCE

- Audits - GMP, GLP, GCP due diligence - manufacturers, laboratories, suppliers, CRO's and Clinical Trial sites
- GMP Quality Systems and Procedures, Standard Operating Procedures (SOP’s)
- Quality Agreements
- Quality Assurance oversight of contract services, quality person in plant
- Risk Assessments
- Batch Record Review, Disposition, Batch Release
- Investigations, Corrective Action and Preventive Action
- Review Master Batch Records, Device History Records, manufacturing procedures
- Review Master Validation Plans, Protocols /Reports for Process Validation, Equipment Qualifications
- Test Method Validation Protocols/ Reports, review analytical methods
- CMC Review (Chemistry, Manufacturing, Controls)
- Preparation for Pre-Approval Inspections
- Consent decree remediation
- Training - SEMINARS AVAILABLE ON SITE

DEVELOPMENT

- Quality support for all aspects of drug substance, drug product and device development
- Chemistry, Manufacturing and Controls (CMC)
- Master Batch Record development
Test Method Qualification and Validation
- Technology Transfer
- Clinical Trial Materials
- Implement Phase appropriate GMPs and quality systems
- Commercial launch preparations
- Contract Manufacturing Organization Selection and Support globally
- Supplier Qualification – FDA, European global expectations.

REGULATORY COMPLIANCE

- GMP regulations for clinical development and clinical trial material – FDA, EMA, global
- GMP compliance for commercial drug manufacture and testing.
- Inspection and Warning Letter Response and follow up – FDA, European, Global
- Consent Decrees - recovering from them, understanding their impact
- Implementing management controls, including internal audits and performance metrics
- Meeting new FDA and ICH expectations for senior management responsibility for quality
- Assessing and enhancing quality assurance and controls
- Prevent and resolve compliance problems
- Evaluation of written procedures and standard operating procedures
- Reviewing and enhancing competence of quality units, production, laboratory
More Services
Consulting about Healthcare Companies:
Interpret and Explain Issues with Drug and Device Quality, Manufacturing, Regulatory Approval
 Expert on the issues and procedures relating to FDA 483’s, Warning Letters and Consent Decrees
 Expert on European and Global Regulatory issues
 Assess the significance, impact of operational and quality issues and how long it may take to correct them
 Manufacturing and regulatory expert speaker on many Street calls
 Helena has consulted to Fund Managers, Analysts worldwide on Biologics, Biotech, Small Molecule Drug, Device Companies and the impact of quality and regulatory issues. Keynote speaker at Cowen Health Care Conference in Boston.
 Helena has the scientific background and hands on experience to understand healthcare technology and operations and enjoys explaining issues at the company of interest!
 

Additional Information

Additional Info
MEMBER: Parenteral Drug Association (PDA), American Chemical Society, Regulatory Affairs Professional Society.

Download my brochure: https://chemconsultants.org/resources/Documents/Helena%20Champion%20DQA%20LLC%20Quality,%20Regulatory%20Compliance%20_%20IT%20expertise,%20services.pdf
Experience
Helena has over 25 years of U.S. and international experience in pharmaceutical and biotechnology manufacturing and testing and product development. She was a Quality Assurance Director at Wyeth Biotech and before that held senior positions at Biogen, Genzyme, Millipore and Cambridge Isotope Laboratories/Otsuka Pharmaceuticals.

Helena brings you expertise based on wide QA, Regulatory Compliance and hands on product development experience in pharmaceuticals and medical devices, also developing and testing clinical diagnostic reagents, working with CMO’s and suppliers worldwide. Helena has worked on numerous clinical development programs through to commercial launch and ongoing quality support of commercial products.

Helena has extensive experience leading Quality Audits and due diligence audits. She is also experienced evaluating and remediating FDA Consent Decrees, Warning Letters and 483s.

Helena’s active pharmaceutical ingredient (API) experience includes small molecule synthesis, cell culture, fermentation, biotech, biologics and vaccines. Her drug product experience includes aseptic processing of biotech drugs, parenterals, oral liquid, tablet, inhaled dosage forms and packaging. Her device experience includes quality support for various devices and drug device combinations and she is familiar with numerous manufacturing technologies for devices. Helena provides a practical approach from years of hands on product and process development and analytical chemistry laboratory and device testing work.

A Masters in Science graduate from the University of Guelph, Ontario, Canada, Helena did her research and thesis on development of HPLC methods for separation of peptides. She did her MBA at Northeastern University, Boston, MA. Her scientific background is in analytical chemistry, organic synthetic chemistry, protein chemistry, biology, microbiology and biochemistry.

Helena advises Fund Managers, Venture Capital groups - explains technology and regulations and evaluates the operational capabilities and vulnerabilities of drug and device companies.
More Experience
2008 – present Drug Quality Assurance, LLC.
PRINCIPAL CONSULTANT
Quality & regulatory compliance support for all stages of clinical development & commercial manufacture.
• Set up Quality Systems, standard operating procedures, Quality Agreements, support technology transfer
• QA and regulatory compliance for small molecule cancer therapeutics, biotechnology cell culture and microbial fermentation, biologics, vaccines and parenteral, transdermal, oral, topical drug products
• Develop, review Master Batch Records, Test Method Validation, Process Validation Protocols, Reports.
• Create procedures for Batch Record review, product release, disposition and perform review and release.
• Perform GMP, GLP, GCP internal audits and external audits, write reports, evaluate responses. Audit small molecule and biologics API manufacturers, drug product manufacturers of all types - oral dosage forms, inhaled, aseptic fill and finish, devices; contract testing labs, excipient, packaging suppliers
• Create external and internal audit programs and schedules, train personnel in performing audits.
• Supplier risk assessment, Supplier Qualification for drug, device, components, distribution, testing labs.
• QA, regulatory compliance for devices. Advise clients on 2011 changes in medical device regulations.

2006 – 2008 Wyeth Biotech, Biotech External Supply, Wilmington, MA.
QUALITY ASSURANCE DIRECTOR.
Directed the External Supply Quality group – responsible for quality oversight of cell culture and small molecule drug substances (API’s), vaccines made by contractors, and aseptic fill and finish drug product.
• Managed quality oversight of multiple contractors, collaborated with contractors to improve compliance.
• Prepared for and hosted FDA and other Agency Inspections, wrote responses to observations.
• Implemented Management Controls, led Management Review meetings, global regulatory compliance.
• Identified, remediated Quality Systems issues, performed Risk Management.
• Consent Decree remediation. Evaluated Internal & External Audit results. Improved Quality Agreements.
• Streamlined Batch Record review and Product Release and Disposition procedures.
• Mentored QA Managers to enhance control of contractor quality performance.
• Led and resolved complex investigations, improved Corrective & Preventive Action (CAPA) management.
• Developed Contractor Risk assessment tools, Bioburden Risk Assessment procedures.
Honors and Awards
RECENT PRESENTATIONS:
• New England Chapter, Parenteral Drug Association speaker. March 13, 2013 "Pharmaceutical Supplier Quality for the 21st Century" – global update.
• How to Overcome Industry Challenges Posed by Requirements for More Supplier Audits, IVT 3rd Forum on Supplier Quality, 8 November 2012, Philadelphia, PA.
• Keynote speaker at Informa Biopharmaceutical Raw Materials Conference, 27-28 June 2012, Cologne, Germany, topic: Effectively Managing Raw Materials throughout the Product Lifecycle.
• Chairperson at Viral Safety for Biologics Conference (Informa) 27-28 June 2012, Cologne.
• Faculty speaker, “Assess the Current GMP Standards for Supplier Quality” at the Second Annual West Coast Forum on Supplier Audits, San Diego, CA, September 13 – 15, 2011 (CBI/Institute of Validation Technology).
• Led Workshop on "Establish Risk Assessment Programs for Supplier Quality Management" at the Supplier Audits Congress, San Diego, CA, November 15-17, 2010 (CBI/Institute of Validation Technology).
Education
MBA (1985), Northeastern University, Boston, MA.
MS (1981), Food Chemistry, University of Guelph, Ont., Canada. Thesis: Development of HPLC methods for peptides.
BS Honors, Plant Biochemistry, Rhodes University, South Africa.
BS, Biological Science & Chemistry, Natal University, Durban, S.A.
IRCA certified Pharmaceutical Quality Management Systems Lead Auditor /GMP Lead Auditor. ISO 9001 Auditor.
Qualified IPEA Excipient GMP Auditor.
Patents
European patent: Multiwell filtration device (patent assigned to Millipore Corporation)
Publications
RECENT ARTICLES AND PRESENTATIONS:
• Ensuring Drug Quality in a Global Economy, Contract Pharma May 2014. http://www.contractpharma.com/issues/2014-05-02/view_features/ensuring-drug-quality-in-a-global-economy/
New England Chapter, Parenteral Drug Association speaker. March 13, 2013 "Pharmaceutical Supplier Quality for the 21st Century".
• How to Overcome Industry Challenges Posed by Requirements for More Supplier Audits, IVT 3rd Forum on Supplier Quality, 8 November 2012, Philadelphia, PA.
• Audit-Sharing Can Lead to Fewer Supply Chain Headaches, PDA Letter, October 2012, www.pda.org/pdaletter
• Shared Supplier Audits - A new day for supply chain quality, Contract Pharma, September 2012, http://www.contractpharma.com/issues/2012-09/view_features/shared-supplier-audits-275514/
• Keynote speaker at Informa Biopharmaceutical Raw Materials Conference, 27-28 June 2012, Cologne, Germany, topic: Effectively Managing Raw Materials throughout the Product Lifecycle.
• Chairperson at Viral Safety for Biologics Conference (Informa) 27-28 June 2012, Cologne.
• Supply Chain Focus: Global Quality Issues - Hope is not a Supplier Qualification Strategy, Contract Pharma, October 2011 http://www.contractpharma.com/issues/2011-10/view_features/supply-chain-focus-global-quality-issues/
• Hope is not a Supplier Qualification Strategy! http://www.contractpharma.com/contents/view_expert-opinions/2011-05-19/quality-in-the-global-supply-chain-for-pharmaceuti/
More Publications
• Quality in the Global Supply Chain– Lessons learned from the Heparin scare - FDA and European approaches to supply chain security, Contract Pharma, October 2011 http://www.contractpharma.com/issues/2011-10/view_features/supply-chain-focus-global-quality-issues/
• Faculty speaker, “Assess the Current GMP Standards for Supplier Quality” at the Second Annual West Coast Forum on Supplier Audits, San Diego, CA, September 13 – 15, 2011 (CBI/Institute of Validation Technology).
• Led Workshop on "Establish Risk Assessment Programs for Supplier Quality Management" at the Supplier Audits Congress, San Diego, CA, November 15-17, 2010 (CBI/Institute of Validation Technology).
• “Global Supply Chain Quality Problems – What Next,” page 21, PDA Letter, March 2010.
• “Assuring Quality in the Global Supply Chain - Measuring risk in sourcing”, in Contract Pharma, September 2009.
• 'Global Supply Chain Quality Problems-What Next?', in the Parenteral Drug Association New England Chapter Newsletter, October 2009.
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