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It is difficult to keep up with changing Current Good Manufacturing
Practices (cGMP) and regulatory requirements. Our associates are
experienced professionals who keep pace with the ever changing
regulations as well as the state of the validation industry. We can
help you to plan, develop, and implement regulatory and compliance
programs including:
- Facility
/ System Design Review
- 21
CFR Part 11 - Electronic Records and Signatures
- Laboratory
Controls
- Documentation
Management and Control
- Regulatory
Submissions
- GMP
Drivers in Technology Transfer
- Validation
Management
- Internal
and Vendor Audits
- Training
Programs
- Environmental
Monitoring Program Development
- Microbiological
Assessment of Manufacturing Processes
- Development
of Quality Manuals and SOPs
- Batch
Record Review
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