Regulatory Compliance
FDA design and manage turnkey projects for the Pharmaceutical and Healthcare industry; from initial front end feasibility studies through to final handover including:
q User Requirement Specification
q Validation Master Plan
q Validation matrix
q Criticality Analysis
q Validation protocols
q Validation report execution
q Standard Operating Procedures
q Engineering Operating Procedures
q Clean In Place / Sterilise In Place
q General cleaning
q Maintenance strategy
q Training
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