Quality Consulting
Experience and knowledge
Experience and knowledge
- 30 years USA, European, UK experience pharma & biotech GMP manufacture, testing
- Hands on product development
- Helena was Quality Director at Pfizer (Wyeth Biotech), held senior positions at Biogen Idec, Genzyme, Millipore, 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
- Bachelors in Chemistry, Biology
- MBA Northeastern University Boston
- Worked on many Clinical development programs to commercial launch, support commercial products
Quality Systems, Regulatory Compliance
Quality Systems, Regulatory Compliance
- FDA/ European/ global regulations
- GMP, GLP, GCP
- Led over 60 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
Quality oversight of contract manufacture and testing
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 Method Review
- Supplier qualification, Supply Chain Quality
- Expert on water systems
- Clinical diagnostic reagents
- Chemistry, Manufacturing Controls (CMC) review