Qualifications:
- Performed over 50 contract research organization, vendor, and software developer audits
- Pharmaceutical/biotechnology professional with over twenty-five years of experience.
- Hosted as Director of Quality Assurance a successful (no FDA-483 issued) four-day audit
of a newly constructed contract research facility
- Hosted four successful FDA audits (no FDA-483 issued) at Fortune 50 pharmaceutical research
facilities
- Hosted numerous Federal, State and client audits and inspections
- Experienced writer, author and reviewer of technical documents
- Lecturer on quality assurance and regulatory compliance topics
- Experienced in analytical methods development and validation
- Adjunct faculty in Community College level Quality Control, Quality Assurance,
Reliability
- Certified Quality Auditor, American Society of Quality
- Registered Quality Assurance Professional - GLP, Society of Quality Assurance