Expert Profile
Yasamin Ameri
President, Quest International Consulting
Yasamin Ameri,MS. RAC, IRCA & RABQSA Lead auditor, is the president of Quest International Consulting in Lake Forest, California. Ms. Ameri has over 22 years’ experience in design and implementation of quality systems, compliance, and regulatory affairs for FDA regulated drug and device manufacturers. She is expert in dealing with all aspects of the FDA approval process for drugs, biologics, medical devices, and generic drugs. In 2006 she designed a course on regulatory requirement for pharmaceutical products for University of California Extension program and taught that course for 7 years.
She has also authored, reviewed, complied, and submitted numerous FDA submissions (IND, NDA, DMF, amendments, and supplements) on her client’s behalf. She is expert in assessing product and facilities and performs gap analysis relative to FDA requirements. She has hosted many FDA inspections for PAI and facility registrations and has helped clients with their compliance issues with FDA to respond to FDA warning letters and successful remediation with FDA.
Trainings by Expert
Site Preparation Strategy and Successful FDA Inspection
Category:
Drugs and Chemicals (Pharma)
,
Clinical Research
,
Audits & Inspections
,
Clinical Trial Regulations
,
Audit & Inspection-Role
,
Clinical Research Audit
,
Documentation and Policy Management
,
Lifescience process & Procedures
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Documentation and Data Management
Supplier Qualification Audit, A Risk Based Approach
Category:
Drugs and Chemicals (Pharma)
,
Medical Devices
,
Biotechnology
,
Testing and Validation
,
Documentation and IT
,
Quality and Safety
,
Audits & Inspections
,
QMS, ISO 13485, CAPA
,
Supply Chain and Manufacturing
,
Quality & Safety
,
Drugs Regulations
,
Biotech Regulations
,
Audit & Inspection-Role
,
Medical Device Inspection
,
Drugs Inspections
,
Documentation and Policy Management
,
Lifescience process & Procedures
,
Life sciences QA/QC
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Documentation and Data Management
,
QA/QC
