Pacific BioMed Consulting
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➢ Remediation / Regulatory Response
o Form 483 Response
o Warning Letter Response
➢ GXP AUDITING
o Clinical Laboratory Auditing
o Quality Control Laboratory Auditing
o Raw Material Supplier Qualification
o Contract Manufacturing Organization Compliance
o Internal Audits (Quality Systems Assessment)
➢ Compliance Gap Assessment for Quality Systems
o Production
o Facilities & Equipment
o Laboratory Controls
o Materials System
o Packaging & Labeling
o Quality
➢ GMP Facility Build Out Design & Planning
➢ Environmental Monitoring Plan Development
➢ Person in Plant Representation
➢ cGMP Training
o New Employee Training
o Focused Training (Specified Topics)
o Refresher Training
➢ Document Control System—Implementation & Maintenance
SERVICES
TEL: 858-245-8382