SAMUEL LAINEZ profiles

  • 5 of 5 profiles
  1. Samuel Lainez

    Title
    Owner, confinis usa
    Demographic info
    Orlando, Florida Area | Medical Devices
    Current
    Partner at confinis, Independent Consultant at Medical Device Industry
    Past
    Corporate Electrical Engineer at Kendall Healthcare, Automation/Process Engineer at Ethicon
    Education
    St. Mary's University, Louisiana State University and Agricultural and Mechanical College
    Summary
    Regulatory Expertise: Design Controls, Electronic Records & Electronic Signatures/ 21 CFR Part 11, ISO13485, GAMP4, GAMP5, Quality System Regulation, System Development Lifecycle, Quality System/SOP Development, Training. Technical Expertise: Engineering - Process, Medical Devices - Durable, PLC Programming, Project Management, Sterilization - ETO, Validation: CSV, Software, Process, Utility/Facilities, SAP (MM, PP, QM) Working with clients in the pharmaceutical, medical device, biologic, and biotechnology industries to develop quality assurance and regulatory strategies for compliance with FDA and EMEA regulations by: ·Conducting assessments of client studies, procedures, and programs to determine compliance. ·Assisting with development and implementation of quality systems and validation programs. ·Developing and implementing corrective action plans to address deficiencies. ·Presenting GMP/QSR training. ·Developing quality policies and procedures as related to validation
    Samuel Lainez
  2. Samuel Lainez

    Title
    Asistentes ─░stanbul ├ťniversitesi
    Demographic info
    Honduras
    Education
    İstanbul Üniversitesi
    Samuel Lainez
  3. Samuel Lainez

    Title
    --
    Demographic info
    United States
    Samuel Lainez
  4. Samuel Cruz lainez

    Title
    --
    Demographic info
    Honduras
    Samuel Cruz lainez
  5. Samuel Ramos Lainez

    Title
    Catedratico en Instituto Tecnico Abelardo R. Fortin
    Demographic info
    Honduras | Primary/Secondary Education
    Current
    Catedratico en Instituto Tecnico Abelardo R. Fortin
    Samuel Ramos Lainez