GMP/GLP/ GCP QUALITY support
Biotechnology, Pharma
Drug & Device Development, Manufacture, Testing, Clinical Trial Materials
QUALITY Assurance, REGULATORY COMPLIANCE, CMC Review
Quality oversight of contract manufacture and testing, Experience and knowledge
Quality oversight of contract manufacture and testing, Experience and knowledge
Quality oversight of contract manufacture and testing, Experience and knowledge
Helena: Masters in Science, University of Guelph, Ontario, Canada, research thesis development HPLC methods for peptide separation
Bachelors in Chemistry, Biology
MBA Northeastern University
30 years USA, European, UK experience pharma & biotech GMP manufacture, testing
- Helena was Quality Director at Pfizer (Wyeth Biotech), senior positions a
Helena: Masters in Science, University of Guelph, Ontario, Canada, research thesis development HPLC methods for peptide separation
Bachelors in Chemistry, Biology
MBA Northeastern University
30 years USA, European, UK experience pharma & biotech GMP manufacture, testing
- Helena was Quality Director at Pfizer (Wyeth Biotech), senior positions at Biogen, Genzyme, Millipore, Cambridge Isotope Labs /Otsuka
- expert in Master Batch Record development
- Batch Record Review
- Investigations, Corrective Action and Preventive Action
- Technology Transfer
- Master Validation Plans, Process Validation, Protocols Reports Equipment Qualifica
- Test Method Validation
- Analytical Method Review
- Supplier qualification, Supply Chain Quality
- Expert on water systems
- Chemistry, Manufacturing Controls (CMC) review
- Hands on product development
- Wide QA, Regulatory Compliance experience drugs, medical devices
- Worked on many Clinical development programs to commercial launch, support commercial products
Helena's
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" – 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.
· 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/
· 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.
INFORMATION TECHNOLOGY, COMPUTER SERVICES
Quality oversight of contract manufacture and testing, Experience and knowledge
Quality oversight of contract manufacture and testing, Experience and knowledge
Ian Champion
BS Business Administration,
American University
- Systems administration
- IT, Software support
- Database support
- Software maintenance, testing,
- QA
- Systems Integration
- Troubleshoot, diagnose and solve issues
- FDA 21 CFR Part 11, Electronic Records expertise
- Data Integrity Compliance for Computerized Systems
- Security Expertise
Quality Systems, Regulatory Compliance
Quality oversight of contract manufacture and testing, Experience and knowledge
Quality Systems, Regulatory Compliance
- Lead GMP, GLP, GCP Audits
- FDA/ European/ global regulations
- GMP, GLP, GCP
- led over 80 Audits worldwide
- Active Pharmaceutical Ingredients (API)
- Drug Products
- Quality Agreements
- Quality Systems
- Standard Operating Procedures / SOPs
- Risk Assessment
- Training
- Pre-Approval Inspection prepare
- Inspection and Warning Letter Response and follow up.
- Consent De
- Lead GMP, GLP, GCP Audits
- FDA/ European/ global regulations
- GMP, GLP, GCP
- led over 80 Audits worldwide
- Active Pharmaceutical Ingredients (API)
- Drug Products
- Quality Agreements
- Quality Systems
- Standard Operating Procedures / SOPs
- Risk Assessment
- Training
- Pre-Approval Inspection prepare
- Inspection and Warning Letter Response and follow up.
- Consent Decree remediation
- Management controls, internal audits and performance metrics
- Meet new FDA and ICH expectations for management responsibility