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- Audit and remediate
- - lead auditor for cGMP, QSR, PAI, PAS, mock, supplier (ASQ Certified Quality Auditor), revise QMS and SOPs in US, EU, and Asia
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Gap and risk assessment
- - identify and mitigate areas of potential concern/issue and suggest options as well as remediate
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Quality management systems
- - SOPs and GMP compliance per cGMP/QSR/ISO 13485 include set-up and train
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- Sterile DP CMOs from Fill Finish to commercial Packaging and Labeling
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CMC (PMA, IDE, IND, BLA/NDA)
- - CMC and BLA/NDA: IND module 2.3/3, manufacture, control, stability, CCI, MBR & release, process develop, packaging and labeling (P&L), QTPP, CMO source/select/manage, CDRH. Authored 2 BLA sections 3.2.P.2 and 3.2.P.7
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CMO
- - Site management & oversight, batch record review & release, investigation, compliance to GMP and internal requirements, tech transfer, process validation, GMP commissioning, quality agreement, PAI/HA inspection readiness
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- 15 years of drug-device combo product development, manufacturing, human factors, risk management and design control:
- - 10 PFS - Actemra, Lebrikizumab, Rontalizumab, aPCSK9, HA H, HA Filler L, Biobetter G, generic S, biosimilar D, Biobetter S (include BLA submission with 1 minor IR from FDA)
- - 5 Auto and Pen injector - Actemra, Nutropin, X, biosimilar S, biosimilar D
- - Nebulizer - Pulmozyme
- - Patch pump – Crenezumab
- - Class 3 device per EU/combo product per FDA (set, diluents, DP vials)
- - Implantable mini-pump (deliver GLP-1), placement tool, procedure kit
- - LED tip catheter and introducer (Talaporfin Sodium to treat solid tumors)