QA/QC experience working with FDA ICH and Japanese regulations 21 CFR reviewing Writing editing submission documentation SOPs Protocols Reports. Product/Project analytical requirements evaluation budget in-house vs. out-source estimation. Upgrading of R&D laboratories to GLP/GMP level.

Highlights:

Companies I like:

small start-up company

• methods transfer validation
• phase I, II, III protocols and reports
• GMP GLP
• Laboratory management
• hiring training budgeting
• FDA ICH regulations
• validation monitoring transfer
• medical devices
• Consulting
• Document Review
• Documentation
• DSC
• High Performance Liquid Chromatography (HPLC)