Consultant

  (610) 462-4090

  info@qualitysolutionsnow.com

Professional with strong experience in quality assurance, regulatory affairs, program management, and laboratory management. Highly credentialed with years of experience in top drug, biologics, and medical device manufacturing industries. Background in biologic/drug/device combination products (topicals, transdermals, inhalers, pre-filled pens and cartridges, and implants), biologics, sterile drug products, and solid oral dosage forms (solutions and suspensions), over-the-counter drug products, pumps, patches, nebulizers, and various other medical devices (sterile and nonsterile), including software-controlled devices.

CORE COMPETENCIES

  • Quality Assurance/Quality Control
  • Purchasing Control/Supplier Control
  • Quality Engineering/Regulatory Affairs
  • CAPA/Root Cause Investigation
  • Design Control/Design History Files
  • Management Review/Medical Device Reporting
  • Project Management/ Technical Writing
  • 21 CFR Parts 4/210/211/803/820
  • Corrective Action/Preventive Action
  • Risk Management/FMEA/Hazard Analysis
  • Change Control/Change Management
  • Quality Systems/Procedural Development
  • Pre-Approval Inspections/Audits
  • Council Directive 93/42/EEC
  • ISO 13485/ISO 14971
  • Process Improvement/Quality Initiatives

SELECTED ACCOMPLISHMENTS

  • Managed device-related pre-approval readiness activities for two drug-device combination products, including:
    • Led design reviews and risk management reviews.
    • Prepared design history file (DHF) indices
    • Conducted retrospective review of product design history files and completed compilation of associated DHF records.
    • Completed retrospective investigation, resolution and documentation of unresolved quality issues.
  • Managed various project activities for pre-commercial drug/device manufacturer implantable product, including:
    • Led internal writing and review process for New Drug Application, Chemistry, Manufacturing and Controls (CMC) modules for two products; identified drug and device-specific content gaps, participated in risk assessment and supported identification and implementation of remedial actions to ensure FDA approval.
    • Led internal writing and review process for Investigational New Drug (IND) Annual Report and CMC amendments to support device modifications for to-be-marketed (TBM) product.
    • Co-developed device usability study protocol for TBM.
    • Supported preparation of Pre-NDA meeting briefing package and meeting rehearsals for meeting with CDER and CDRH.
    • Authored and implemented quality system procedures for design controls, risk management, purchasing controls, quality audits, management review, medical device reporting, CAPA, complaint handling, and handling of recalls in compliance with applicable 21 CFR Part 4, 210/211, 803 and 820 regulations. –
    • Audited DHF and provided guidance in addressing compliance gaps.
    • Provided support for conducting investigations of out-of-specification product.
    • Provided support for design and implementation of device-specific stability studies.
    • Served as member of combination risk management team, and draft final labeling review team.
  • Managed remediation activities involving approved drug products, subject to FDA consent decree for multi-national pharmaceutical company, including:
    • Led process validation assessment, and retrospective validation strategy development and implementation for all commercial products, subject to FDA review.
    • Ran re-engineering of batch record review and lot release procedures, leading to cessation of third party batch release as part of consent decree.
    • Directed re-engineering/process improvement efforts for design of master batch records for bulk manufacturing and packaging and labeling operations.
    • Headed re-engineering/process improvement of analytical laboratory operations.
  • Served as process validation, independent third-party independent assessor for multi-national pharmaceutical company under FDA consent decree, subject to FDA review.
  • Provided quality and regulatory support for biologic/drug/device manufacturer, from Phase 1 through Phase 3 clinical development, including:
    • Resolved Complete Response Letter (CRL) issues pertaining to Phase 2 analytical method validation for biological assay.
    • Established and implemented drug-specific quality systems to address 21 CFR Parts 210/211.
    • Conducted device constituent design verification and design validation testing.
    • Prepared and submitted device master file (MAF) for device constituent. – Audited contract manufacturers, suppliers, clinical research organizations, and clinical sites.
    • Completed CMC IND Amendments to support drug substance (DS) and drug product (DP) changes, including site change, process changes, formulation changes, specification changes, and analytical method changes.
    • Served as member of CMC/product development team, supporting transfer and scale up of DS and DP manufacturing.
    • Provided support in obtaining State of CA facility license, including cGMP training and handling of inspections.
  • Led ISO 9001 registration and Medical Device Directive to allow CE marking of software-controlled device for a device and drug-device manufacturer, including:
    • Established quality manual and quality system procedures in compliance with 21 CFR Parts 4, 210, 211, 803, and 820.
    • Prepared and submitted device 510(K)s, Clinical Trial Applications (CTAs), and INDs.
    • Served as program manager for inhalation drug/device combination product development, including Pre-IND meeting.
  • Served as Acting Quality Director and supported implementation of commercial procedures to support launch of biologic/device autologous product, including establishment of returned drug product and biologic drug product reporting systems.
  • Served as quality lead for pre-approval readiness, quality system improvement initiative for a drug/device manufacturer of a software-controlled inhalation product, including: ­
    • Audited quality systems and conducted gap analysis. ­
    • Planned and implemented corrective actions. ­
    • Established design control, risk management, management review, CAPA, label control, master production record, and re-design of format and content procedures.

PROFESSIONAL EXPERIENCE

  • Medicines360, RA/QA Consultant – 2013 to 2014
  • SteadyMed, QA Consultant – 2013 to 2013
  • Christine Flahive Consulting, Consultant – 2009 to Present
  • Alexza, QA Consultant – 2008 to 2010
  • LexaMed Consulting, Consultant – 10/2007 to Present (Client Projects: AAP, Merck, Watson, Eli Lily, Dendreon)
  • Signature Therapeutics, QA Consultant – 2007 to Present
  • Revance Therapeutics, RA Consultant – 2007 to Present
  • Intermmune, Sr. Director, CMC Regulatory Affairs – 2006 to 2007
  • Titan Pharmaceuticals, Sr. Director, Quality – 2004 to 2006
  • Alpharma, QA Consultant – 2002 to 2004
  • Aerogen, Sr. Director, Quality/Regulatory, Program Management – 2000 to 2002
  • Cholestech, QA Consultant – 1999 to 2000
  • Shaklee Corporation (Yamanouchi Shaklee Pharma) Compliance Officer – 1998 to 1999
  • InSiteVision, Sr. Director, Quality/Regulatory – 1996 to 1998
  • Syntex, Manager, Quality – 1993 to 1996
  • Genentech, Sr. Quality Specialist -1991 to 1993
  • Johnson & Johnson, Sr. Quality Specialist -1988 to 1991
  • Shaklee Corporation, Microbiology Laboratory Manager – 1979 to 1988

EDUCATION

  • Bachelor of Science, Microbiology, South Dakota State University – 1979
  • Master of Business Administration, Golden Gate University – 2002

CERTIFICATION

  • Certified Quality Engineer (CQE), American Society of Quality – 1988
  • Certified Quality Auditor (CQA), American Society of Quality – 1990

AFFILIATIONS

  • American Society for Quality (ASQ), Former Fellow member (2003). Former Certification Board Member; Quality Engineering Certification (CQE) – former exam chair (1995 to 2000).
  • Malcolm Baldrige National Quality Award (MBNQA) for Performance Excellence; Former Senior Examiner; Team Leader; Feedback Writer.
  • Itnl. Standards Organization (ISO), Former US voting member; ISO quality management standards.

PUBLICATIONS AND PRESENTATIONS

  • American Society for Quality (ASQ), Quality Audit Division, Annual Conference. Speaker, Quality Management Systems.