Due Diligence Evaluation for Quality Systems (cGMP)
Development of Quality Strategy and Quality System (cGMP)
Preparation for FDA pre-approval inspections
Pre – FDA inspections
Audits of vendors and service providers
Development of manuals: Site Master File (EU requirement), Quality Manual, Quality Policy Manual (ISO 9001:1994, ISO 9001:2000, ISO 13485:1996, ISO 13485:2003)
Regulatory Compliance
Evaluation of Quality Systems
Site and Product Registration
Internal GMP Audits
SOP Preparation
Analytical Laboratories Audit
Drug Master File Preparation for
Drug Master File (DMF) in CTD
Certificate of Suitability (COS) Dossiers in CTD
Prepare responses to regulatory queries
Correct Adverse Findings
Pre-Approval Inspections
Risk Assessment of Supplies
Training
GMP Basics
Regulatory Compliance
Technical/Scientific Issues
In-house Seminars
Validations
Installation and Operation Qualification
Validation Procedures
Cleaning Validation
Process Validation
Prepare Validation Protocols
Protocol Implementation
Data Collection/Analysis
Analytical Methods Validation
Process Development
Scale-Up from Pilot to Production
Process Optimization
CMC Documentation
Technology Transfer
Risk Analysis Study
Relevant Documentation
CMC (Chemistry Manufacturing Controls)
Stability Studies
Equipment Validation
Process Validation
Test Method Validation
Reviews of compliance documents and records:
Production batch records
Test results
Cleaning protocols and reports (facility and equipment)
