- American & Canadian drug Good Manufacturing Practice audits
- Quality Systems
- Pre-approval inspections
- Good Laboratory Practice reviews
- Vendor audits
- FDA medical device Quality System Regulation audits
- Training in GMP & QSR
- Advice on chemistry and microbiology laboratory practices and method
validation
- Advice on manufacturing systems including purified & water for injection
systems
- Advice on sterile product manufacturing and quality control
- Development of process and method validation protocols
- Functioning as the qualified Person in Charge of the quality control department
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