Areas of Practice
Quality Systems implementation
- New quality management systems from the ground up and upgrades of existing systems
- Lean documentation systems
quality system audits
- Regulatory compliance mock audits
- Internal audits
- Supplier audits
- Third party audits
- Variable-scope process audits
regulatory compliance
- Remediation and compliance turnaround
- Warning letter response and correspondence
- FDA form 483 responses
- Compliance correspondence and meeting support with regulatory agencies
investigations and CApa support
- Non-conformity and Complaint investigation training.
- Non-conformity and Complaint management systems
- CAPA implementation and project management
quality systems training
- FDA GMP
- FDA QSRegulation
- ISO 13485
international quality systems
- US
- EU
- SA