Concept, interpretation, implementation
Benefit from my broad expertise in GMP, Quality Assurance and Quality Management in the Pharmaceutical Industry - identify and fix your cGMP deficiencies before Inspectors do, develop sustainable and compliant concepts and comply with new requirements (FDA, EU, Swiss, ICH).
Routine GMP, Inspection, Specific Topics
Train the trainer, classroom or individual training, specific topics, routine GMP training, inspection readiness / behaviours in inspections training, cGMP practices, etc.
Supplier and CMO Audit, Mock Inspection, Preparation
Get support with your Inspections and Audits: Gap Analysis, Mock Audits, Training, Strategy, Remediation Plan, Authority Response, CMO and Supplier Audits and Supplier Qualification.
Hire a Professional to bridge your staff shortages
Get support with all your Quality Assurance tasks, e.g. Quality Oversight, Quality Projects, Batch Record Review and Technical Release, Change Management, Deviation and OOS Management, CAPA, Technical Quality Agreement, SOP, Contamination Control Strategy).
Quality Strategy, Quality Manual, Quality Processes and Procedures
I help you to develop and implement your QMS or close the gaps in your existing QMS. Get your QMS Processes right (OOS and Discrepancy Management, Complaints, CAPA, Change Control, Process and Quality Monitoring, Training, Management Review, Validation, etc.)
Strategy, Project Management, Support
Validation Strategy, Validation Masterplan, Project Management, Requirements Engineering (URS), GMP Risk Assessment, Qualification of Equipment, Consulting with regards to Qualification / Validation, Process Validation, Cleaning Validation
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GMP Swiss Services
My range of services for the pharmaceutical, chemical, biotech industries includes GMP compliance consulting, audit & inspection management, quality assurance, quality management, quality systems, GMP training, GMP routine support and qualification & validation.
You decide whether you would like a consultancy, have a project implemented or book my expertise on a temporary basis for routine support in the areas of GMP, quality assurance or quality management.
After 30 years in the pharmaceutical industry in various local and global roles, I bring a very broad experience to efficiently support you in safely achieving your compliance goals.
I am very experienced with FDA, EMA, Swissmedic regulations and ICH and pharmacopeia requirements.
If you are interested, please contact me via e-mail, contact form or by phone.
Silvana Frey Owner, GMP Consultant
“With 30 years of experience in the Pharmaceutical Industry and GMP Consulting in various positions in Quality Assurance and Quality Management, Engineering and Project Management you will benefit from my extensive experience. I am very engaged, flexible and customer oriented and passionate about Quality and Solutions Excellence.”
Silvana Frey Owner, GMP Consultant
Your GMP Expert
in Switzerland and Europe
GET IN TOUCH
Please fill in the contact form for additional information or if you have a project which needs expertise and/or resources. I will be happy to provide my support.