|
· Process Validation
· Technology Transfer and New Product Introductions
· Manufacturing Process Support
· Commissioning
· Factory Acceptance Tests (FAT)
· Equipment Qualification (IQ/OQ/PQ)
· Utilities Systems and Facilities Qualification
· Computer System Validation Life Cycle
· 21 CFR Part 11
· Packaging Validation
· Laboratory Equipment and System Validation
· Cleaning Validation
· Project Management
· Master Plans and Technical Documentation |
· Process Automation
· CAPA and Non Conformance Reports
· SOPs Development
· QA/QC and Compliance Support
· Support during FDA Inspections
· Responding to FDA Citations
· Laboratory Investigations and Out of
Specifications Evaluations (OOS)
· Implementation of Compliance Reports
· Analytical Method Transfers and Laboratory
Support
· Controlled Drug Substance Programs under
the DEA Laws and Regulations |
