Expert Profile
Jamie Jamshidi
Quality and Regulatory Advisor, Karyopharm Therapeutics Inc
Jamie Jamshidi, Biotech-Pharmaceutical Quality & Regulatory Advisor has over 27 years of industry experience, including small molecules and large molecule biologicals.
Jamie has a broad understanding of the entire drug development process for both large molecule proteins and small molecules. She has extensive knowledge of U.S. Regulatory Filings through product life cycle, FDA Current Good Manufacturing Practices (CGMP), Current Good Laboratory Practices (CGLP) and Current Good Clinical Practices (CGCP), European and Japanese drug manufacturing regulations, ICH guidelines, and Qualified Person (QP) requirements under EU Directives, and World Health Organization (WHO) regulations.
Jamie also has extensive experience in the development and commercialization of pharmaceuticals and biotechnology at all process stages, including Drug Substance (API), Drug Product, Packaging, and Labeling. She has given numerous lectures and talks in the areas of Quality and Regulatory in several colleges, universities and conferences globally. She is well known in bio/pharmaceutical industry for her passion and respect for laws and regulations in ensuring product quality.
Trainings by Expert
Understanding CFR Part 210-211 Requirements for Drug Products
Category:
Drugs and Chemicals (Pharma)
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FDA 21 CFR Part 11
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Quality and Safety
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Supply Chain and Manufacturing
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Drug Development
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Drugs Regulations
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Research & Development
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Drug R & D
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Regulations & Guidances
,
Life Sciences
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Regulatory Affairs
Validation Requirements Based on ICH Q9
Category:
Drugs and Chemicals (Pharma)
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Quality and Safety
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Life sciences QA/QC
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Life Sciences
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QA/QC
Understanding the Current FDA Requirements for Raw Materials and Components
Category:
Drugs and Chemicals (Pharma)
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Risk Management
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All FDA Regulated Industry
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FDA Audit and Inspection
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Quality and Safety
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Risk Management & Controls
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All FDA Regulated Functions
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Audit & Inspection-Role
,
All FDA Reg. based Audit
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Life Sciences
NEW Guidance for Industry: CGMP for Phase I Investigational Drugs
Category:
Drugs and Chemicals (Pharma)
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All FDA Regulated Industry
,
FDA Audit and Inspection
,
Quality and Safety
,
Audit & Inspection-Role
,
All FDA Reg. based Audit
,
Best Practices & GXPs
,
Life Sciences
Auditing an Active Pharmaceutical Ingredient (API) Contract Manufacturing Organization (CMO)
Category:
Drugs and Chemicals (Pharma)
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Quality and Safety
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Audits & Inspections
,
Supply Chain and Manufacturing
,
Life Sciences
