Consultants with years of experience in Quality Assurance, Quality Control, Compliance and Regulatory. Extensive industry knowledge with domestic and international experience in Biotechnology, Pharmaceutical Sterile manufacturing, CAR-T, Nutraceuticals, Food, USDA and Contract manufacturing sites such as Pfizer, Eli Lilly, Sanofi and more. Areas of expertise also include Laboratory Operations, Inspection Readiness, Quality Systems, and Process Improvement. Skilled at conducting laboratory and facility audits, compliance training, batch assessments, playing a key role in the implementation of Quality Systems & ensuring completion of regulatory commitments.
Involved successfully in consent-decree, NDA, lifting of import alert, remediation of warning letters, batch assessments for release to the US market & Pre-Approval Inspection projects ensuring completion of commitments.
Involved successfully in consent-decree, NDA, lifting of import alert, remediation of warning letters, batch assessments for release to the US market & Pre-Approval Inspection projects ensuring completion of commitments.
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Dr Loay Alikhan
CEO & Senior Consultant |
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Learn From the Best
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• FDA audit readiness.
• Batch certification and batch assessment. • Deviations and investigations review. • Documents review. • Data integrity audit • Technical writing. • Laboratory Audit. • Training and remediation. • Media Fill. |
•Deviation investigations and CAPA management.
•Quality Assurance and Quality Control Documents,Forms and Testing Procedures. •Environmental Monitoring Protocols |
•Disinfectant efficacy testing protocol, media qualification protocol
•Trend reports. •Risk assessment . •Document review. •Training of microbiology analysts on the protocols. •QC Story board. •Effectiveness checks •Exception report rubric assessment. |
