Ling Lu

Ling Lu Email and Phone Number

Associate Director, Global Process Lead, Design Controls, Device Quality at Bristol Myers Squibb @ Bristol Myers Squibb
United States
Ling Lu's Location
United States, United States
Ling Lu's Contact Details
About Ling Lu

25+ years experience in device and drug development, manufacturing, quality & regulatory, Global Process Lead for design controls at BMS, Co-chaired Regulatory & Quality Device Network at Pfizer, Integrated Design Controls with QbD Principles, Led a group of pharma and device professionals to develop design history files, author device CMC contents for regulatory submission, respond to queries, prepare for internal audits and regulatory inspections.Specialties: Design control process development, submission strategy, audit/inspection, supplier quality, change controls, deviation/CAPA, complaint managementDevice regulatory: 510(k), IDE, PMA, Shonin, EU MDR, IVDRDrug regulatory: CMC, IND, NDA, BLA, CTA, MAARAPS RAC, ASQ CQA

Ling Lu's Current Company Details
Bristol Myers Squibb

Bristol Myers Squibb

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Associate Director, Global Process Lead, Design Controls, Device Quality at Bristol Myers Squibb
United States
Website:
bms.com
Employees:
38469
Ling Lu Work Experience Details
  • Bristol Myers Squibb
    Bristol Myers Squibb
    United States
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  • Bristol Myers Squibb
    Associate Director, Global Process Lead Design Controls, Device & Combination Product Quality
    Bristol Myers Squibb 2020 - Present
    Lawrence Township, Nj, Us
    21 CFR Part 4, 211, 820, EU MDR, IVDR, ISO 13485, ISO 14971, IEC 62366, ISO 11040, ISO 11608, FDA and EMA guidance;Innovative injection devices, IVD/CDx, combination products, packaging & labeling, transportation qualification, shipping validation
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  • Pfizer
    Sr Principal Scientist - Combination Product Design Control Group Lead
    Pfizer 2014 - 2020
    New York, New York, Us
    Combination product regulatory strategy, design control process incorporating QbD principles for PFS, drug kits, cross labelled drug delivery products;Led design control group, developed a dozen of design history files for combination products supporting regulatory submission for clinical trials and commercial licensures.
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  • Hospira/Pfizer Company
    Program Manager New Product Quality
    Hospira/Pfizer Company 2011 - 2014
    21 CFR Part 4 CGMP for combination products;Design Controls for device and combination productsHazard analysis, FMEAs, Complaint analysis, CAPA investigationDeviation and failure analysis & tracking system development
  • Medtronic
    Sr Regulatory Affairs Specialist, Sr Pharma/Device Quality Engineer
    Medtronic 2005 - 2011
    Minneapolis, Mn, Us
    Regulatory affairs, design controls, risk management, pharma and device quality, biocompatibility, leachables & extractables, device shelf life and drug stability, manufacturing and supplier quality, complaint analysis, CAPA, AE report process, product recall.Products: Intrathecal drug delivery, Neurostimulation, drug coated leads, cardiac surgery devices.Regulatory Affairs: 510(k), IDE, PMA supplements, CMC for IND, NDA.RAPS RAC
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  • 3M Health Care
    Sr Quality, Sr Development Chemist
    3M Health Care 1997 - 2005
    St Paul, Mn, Us
    Project lead, device development and drug formulation development.Device: Design control SOP, DHF, risk management, manufacturing and supplier quality, complaint analysis, CAPA management, clinical evaluationDrug: formulation, stability, method development, validation, transfer, GMP Lab SOP.Products: Surgical skin prep, surgical masks, transdermal drug delivery, aseptic drug formulation, sterilization assurance indicators, time indicators.Regulatory: 510(k), CMC, NDACQA, CQE, 6 Sigma
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Ling Lu Skills

Validation Design Control Capa Medical Devices Quality System Regulatory Affairs Iso 13485 Gmp R&d Fda Design Of Experiments Product Development Manufacturing U.s. Food And Drug Administration V&v Quality Auditing Six Sigma Iso 14971 Research And Development Fmea Verification And Validation Quality Assurance

Ling Lu Education Details

  • Illinois Institute Of Technology
    Illinois Institute Of Technology
    Polymer Science
  • Fudan University
    Fudan University
    Materials Science
  • University Of St. Thomas - Opus College Of Business
    University Of St. Thomas - Opus College Of Business

Frequently Asked Questions about Ling Lu

What company does Ling Lu work for?

Ling Lu works for Bristol Myers Squibb

What is Ling Lu's role at the current company?

Ling Lu's current role is Associate Director, Global Process Lead, Design Controls, Device Quality at Bristol Myers Squibb.

What is Ling Lu's email address?

Ling Lu's email address is li****@****hoo.com

What is Ling Lu's direct phone number?

Ling Lu's direct phone number is +176347*****

What schools did Ling Lu attend?

Ling Lu attended Illinois Institute Of Technology, Fudan University, University Of St. Thomas - Opus College Of Business.

What skills is Ling Lu known for?

Ling Lu has skills like Validation, Design Control, Capa, Medical Devices, Quality System, Regulatory Affairs, Iso 13485, Gmp, R&d, Fda, Design Of Experiments, Product Development.

Who are Ling Lu's colleagues?

Ling Lu's colleagues are Jesus Morgado, Ilira Dushku, Anthony Smith, Sylvie Loubieres, Deborah Browne, Kim Namsoo, Lynn Culotta.

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