DTVR SOPs

    Equipment
      D-DEZ-EQP-001 Nitrogen Gas Manifold System

      D-DEZ-EQP-002 Oxygen, Carbon Dioxide and Mixed Gas Manifolds

      D-DEZ-EQP-003Pe Biosperix - Processing Room East

      D-DEZ-EQP-003Pw Biosperix - Processing Room West

    Protocols
      D-DEZ-PRO-001 Dermal Biopsy Sample Collection

      D-DEZ-PRO-002 Plating Passaging and Freezing FBs from Dermal Biopsy Punch

      D-DEZ-PRO-004 iPSC generation

      D-DEZ-PRO-005 Eye Tissue Fix and Cryo-Protect Protocol

      D-DEZ-PRO-006 ICC Protocol for Pre-Fixed Ocular Tissue

      D-DEZ-PRO-009 DNA Ligation Subcloning

      D-DEZ-PRO-010 Preparation of Mounting Media

      D-DEZ-PRO-011 NEB 5 alpha transformation protocol

      D-DEZ-PRO-012 CRISPR cloning - 85nt scaffold

      D-DEZ-PRO-013 gDNA Isolation from cultured cells

      D-DEZ-PRO-015 Evaluation of CRISPR-mediated NHEJ

      D-DEZ-PRO-016 Eye-Tissue prep for cryo sectioning

      D-DEZ-PRO-018 RNEasy Total RNA isolation

      D-DEZ-PRO-019 SuperScript III First Strand cDNa synthesis

      D-DEZ-PRO-020 Transient lipofection in adherent cells

      D-DEZ-PRO-021 Reverse Transcriptase Reaction

      D-DEZ-PRO-023 Western Blotting Protocol

      D-DEZ-PRO-026 Whole Exome Sequencing Protocol

      D-DEZ-PRO-027 Whole Genome Sequencing Protocol

      D-DEZ-PRO-031 Sterile Products Room Classifications

    Computer Operation
      D-GLO-COM-001 Logging into Employee Self Service for Training

      D-GLO-COM-002 Logging onto ICON for GMP Training

    Global Equipment Operation
      D-GLO-EQP-001 2-8C Revco Refrigerator

      D-GLO-EQP-002 -80 Sanyo Freezer

      D-GLO-EQP-003 -80C Revco Ultra-Low Benchtop Freezer

      D-GLO-EQP-004 -20 Freezer

      D-GLO-EQP-005 Sorvall ST 8 Centrifuge

      D-GLO-EQP-006 Ultra Centrifuge

    Global Equipment Qualification/Verification
      D-GLO-EQV-001 Qualifications of New Equipment
    Global Operating Protocol
      D-GLO-PRO-001 Protocol for Standard Operating Procedure

      D-GLO-PRO-002 Standard Forms

      D-GLO-PRO-005 Personnel Responsibilities

      D-GLO-PRO-008 Outside Audits

      D-GLO-PRO-009 LabGuru

      D-GLO-PRO-010 DTVR Calibration and Preventive Maintenance Policy

      D-GLO-PRO-013 Investigating and Reporting Discrepencies and Performing CA PA

      D-GLO-PRO-014 Generating Unique GMP Identifiers

      D-GLO-PRO-015 Ordering, Incoming Material, Labeling, Release and Disposition

      D-GLO-PRO-016 Deviations to Approved Documents

      D-GLO-PRO-018 Generation, Review, and Archiving of Batch Records

      D-GLO-PRO-019 Record Retention Policy for DTVR

      D-GLO-PRO-021 Handling of Adverse Reactions and Patient Complaints

    Global Training
      D-GLO-TR-002 Competency Based Training Program Rev0
    QA Protocol
      D-QA-PRO-001 Quality Assurance Group

      D-QA-PRO-002 Guideline for Rounding Numbers and Determining Significant Figures

      D-QA-PRO-003 Definition of Raw Data and Acceptance of Electronic Documents

    QA Processes Validation
      D-QA-PVL-001 Initial Listing and Annual Update for HCTP Products
    QA Processes Operation/Procedure
      D-QC-PRO-001 Quality Control Group
    Facility Processes Operation/Procedure
      D-FAC-PRO-001 HEPA Filter Leak Testing For Sterile Suites