Quality Consulting
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
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
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