Areas of Expertise

Quality Assurance Operations and System Support

System and Documentation development, review, and approval
Batch Record Review
Validation Protocol Review
Investigation and CAPA development and documentation

GMP Quality Auditing

Supplier GMP audits
Laboratory audits
For-cause audits
PAI Readiness assessment and support
Internal audits
Regulatory Agency audit support

Additional Expertise

Data Integrity Assessment and Remediation
Project Management
Vial Inspection
Cleaning Validation
Environmental monitoring and QC investigations
Quality project support for technical transfers and system migrations

For more details, please click my LinkedIn account below.