Laurie Auerbach

Consultant

Results-driven professional with solid project management, technical and compliance knowledge, skilled in quality systems implementations, change controls, supplier management, inventory management, production and process controls, and regulatory affairs. Broad experience working for top global pharmaceutical, medical device, in vitro diagnostic, combination product, and biologics manufacturers. Background in coagulation disease therapeutics, transdermal products, blood gas and electrolyte analyzers, molecular diagnostic assays for infectious disease and inherited disease, coagulation antibody diagnostic assays, epinephrine injectors, obstetric and gynecological devices, fluorescent sensor chemistry, multi-channel injection molded platforms for assay delivery, LED optical reflectance technology, lyophilization, IVD equipment and reagent filling processes.

CORE COMPETENCIES

Project Management/Leadership
Supplier Management/Material Controls
Technology Transfer/Design Transfer
Change Control/Document Control
Packaging and Labeling Controls
Raw Material Qualification
Risk Management/Hazard Analysis
Stability Protocols/Reserve Sample Programs
Operating Procedures/Work Instructions
Inspection Procedures/Test Methods
Sampling Techniques/Sampling Plans
Design Controls/Design History Files
Computer Systems Implementation
Laboratory Controls/LIMS
Inventory Management/ERP
DHF Remediation/Gap Analysis
Production/Process Controls
Quality Assurance/Regulatory Affairs
Design Controls/Outputs/Reviews
Design Verification/Validation
Traceability Matrices
Quality Systems Development/Support/Auditing
Training/Training Materials/Assessments
21 CFR Parts 4/11/210/211/801/803/820
Council Directives 93/42/EEC; 98/79/EC
Device Software Validation/IEC 62304
Canada Medical Devices Regulations
ISO 9000/ISO 13485/ISO 14971/ISO 17025

SELECTED ACCOMPLISHMENTS

Developed Design Control process and conducted training for an IVD manufacturer of molecular diagnostic systems, including:
- Led 10-week effort with four (4) business units/contract manufacturers to establish harmonized design control approach
- Established phase gate process for a molecular diagnostics platform consisting of lab instrumentation, device software, consumables and reagents, including phase exit requirements, roles, responsibilities and required deliverables for each phase
- Helped establish and document a device software development life cycle (SDLC) using Agile methodology while ensuring compliance with IEC62304
- Created governing design control and risk management quality policies in compliance with ISO 13485, ISO 14971, 21CFR Part 820, IEC 62304, and Council Directive 98/79/EC
- Established DHF electronic binder templates and metadata requirements for assay product development projects including phase review checklists, design review templates, risk management templates, design inputs and output templates, traceability matrix, design verification and validation templates, and technical report templates.
Managed change control activities for a global “virtual” biopharmaceutical manufacturer of over 30 commercial and developmental pharmaceutical and nutraceutical products (mental health, respiratory, dermatology, urology, obstetrics, inflammatory disease, and cardiology) with outsourced manufacturing operations, laboratory testing and distribution at a total of 41 supplier locations and 34 unique suppliers, including:
- Led review and closeout (where applicable) of backlog of 50+ change controls from contract manufacturers and laboratories completed by team of 2 FTE’s in two (2) weeks.
- Oversaw subsequent project to initiate and drive to completion 38 of these changes in OEM quality system. Responsibilities included:
  - Project Management – determined critical path to ensure changes were implemented on time; managed timeline, milestones and resource allocation using Microsoft Project; served as liaison between all impacted functions including CMO Operations, Materials Management, Regulatory, Logistics, Warehouse, and Purchasing; mitigated and communicated any risks to minimize customer impact and delays; communicated project status and changes to stakeholders
  - Managed coordination and completion of associated implementation activities including:
    - Supplier Management – RFI/RFQ; COG Analysis; Capability Analysis; Supplier Qualification (Surveys, Onsite Audits, Manufacturing and Quality Agreements, First Article Inspections), Establishing Inspection and Sampling Plans; technology transfer to new suppliers and/or sites;
    - Inventory Management – BOM creation/updates, Master Work Order Creation/Updates; Material disposition of Raw Materials, Intermediates, Finished Goods and WIP; Rework Orders;
    - Distributor Management – Agreement creation/updates; Issuance of Technical and Customer bulletins;
    - Stability and Reserve Sample Program changes – Stability protocol changes, environmental chamber validations, inventory updates;
    - Raw Material Qualifications – Establishing and documenting release criteria for new suppliers and lots of critical raw materials, inventory cut-in, scrap control and rework;
    - QC Test Method Changes – Compendial updates; Test method transfers and validations; Reference standard changes;
    - Labeling and Artwork Changes – Coordinate with printing vendors, copy approval, inventory reconciliation (e.g. Scrap, Lot # cut-ins); regulatory agency approvals, language translation verification, barcode verification, labeling validation;
    - Packaging Changes – Bioburden testing; Packaging automation process changes and validation, ISTA testing, Shipping studies
  - Examples of Change control projects include:
    - Lead effort to review and update all applicable Raw Material Test Reports (RMTR) for five (5) product lines to ensure test methods and specifications aligned with current compendial and in-house developed test methods to be performed by three (3) different contract laboratories. Implementation of change control resulted in updates to 40+ RMTR’s, 18 Test Methods, completion of three (3) test method transfers, and five (5) test method validations.
    - Managed OEM change control for line extension of prescription topical lotion to add a new bottle size and change packaging design. Implementation activities included qualification of new suppliers, qualifying new bottle size, filling and packaging validation, developing and approving new labeling and artwork (primary and secondary labels, patient information leaflets), labeling validation, ERP updates – creation or revision of BOMs, SKU’s, and Master Work Orders; batch record updates, creating packaging material inspection plans, shipping studies, stability testing, and submission and approval of a CBE-30 with the FDA.
    - Managed OEM change control to add French labeling for distribution of prescription prenatal supplements in Canada. Change control activities included translation of all applicable labeling into French including Patient Information leaflets, carton and bottle artwork, and print mats for blister packs; coordinating artwork changes with printing vendors; execution of distributor agreements; labeling and translation validation; barcode verification; ERP updates, Creation of BOM, SKU’s, and Master Work Order; obtaining required regulatory approvals.
Led project to eliminate two (2) year backlog of open discrepancy and non-conformance reports changes for a global biopharmaceutical manufacturer of 18 outsourced commercial prescription and OTC pharmaceutical products.
- Responsible for conducting investigations, performing root cause analysis, risk assessments, product disposition, and CAPA initiation where applicable, resulting in closeout of over 200 reports in three (3) months
- Investigated 80+ OOS Stability results for marketed drugs resulting in 13 field alerts and two (2) product recalls
- Compiled annual product trending reports on 12 drugs for a two (2) year period and presented to corporate executive management to serve as input for operational process improvement changes.
Conducted a comprehensive audit of manufacturing and laboratory operations for compliance with 21 CFR Parts 210 and 211 for a large active pharmaceutical ingredient manufacturer. Based on findings made recommendations that led to:
- Creation of a validation department;
- Development and automation of a global change control process through implementation of TrackWise, and;
- Implementation of an inventory management system
Conducted a gap assessment of a chemical testing lab of a global combination product manufacturer of implantable products for cardiovascular therapy for compliance with pharmaceutical regulations including:
- Performed a gap analysis of SOPs and business processes against ISO17025, 21 CFR Part 211 and 820, start/stop analysis of current projects, 5-year project and IT systems roadmap, and implementation support requirements
- Created a matrix outlining the differences in the drug and device regulations for each applicable quality system to determine the requirements of each constituent part
- Results highlighted more stringent pharmaceutical requirements for chain of custody, OOS, data management, test method validation, and materials management than medical device requirements
- Provided recommendations for quality system improvements, including re-engineering of business processes and implementing automation systems to focus on meeting compliance needs for combination products (prior to FDA guidance on combination products)
Established the complete supply chain lifecycle process for a medical device manufacturer of a Class III non-invasive cervical neoplasia detection system including developing the following sub-processes and procedures:
- Sales order processing and production planning including receipt and creation of customer purchase orders, production forecasting, master work order creation and management;
- Supplier management program including RFI/RFQ, transfer and management of outsourced processes, supplier qualification process (risk assessment, capability analysis, pilot production and validation runs, survey and audit program, first article inspections, raw material qualifications), supplier performance reviews, approved vendor list management;
- Purchasing process including Engineering and Production purchase order process, PO change control, purchasing and manufacturing terms and agreements, purchased material classifications;
- Inventory management including creating a manual system for control of 450+ unique part numbers and 30+ product SKU’s to include BOM Management, stock quantities and status, and supplier information, scrap control, rework orders;
- Management of acceptance activities including first article, incoming, in-process, and finished goods receipt, inspection and release;
- Warehouse management including receipt of goods, handling and storage of materials to ensure segregation by status and to meet shelf-life requirements, environmental and contamination controls, FIFO, expiry date management, shipping and export requirements, and inventory reconciliation;
- Distributor management including distributor selection criteria, distributor agreements, determining country of distribution requirements, distributor training
Served as supplier quality lead on product development team for a medical device manufacturer of a Class III non-invasive cervical neoplasia detection system utilizing biophotonic technology, including:
- Managed first article inspection for backlog of 400+ machined, injection molded, electrical, optical, hardware, packaging and labeling materials eliminating existing backlog in three (3) months
- Led supplier qualification efforts for 40+ suppliers including performed critical supplier audits for fiberoptic, reference target material, and single use disposable suppliers, created quality agreements, performed risk assessments to determine supplier monitoring requirements, performed SPC analysis on inspection data, and established incoming inspection criteria
- Reviewed all packaging and labelling specifications for compliance with 21 CFR Part 801, 93/42/EEC (MDD), Canada Medical Devices Regulations (CMDR), ISO 15223, ES 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366, and ISTA
- Reviewed all packaging and labelling specifications for compliance with 21 CFR Part 801, 93/42/EEC (MDD), Canada Medical Devices Regulations (CMDR), ISO 15223, ES 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366, and ISTA
- Revised all quality system procedures and created new procedures in preparation for ISO 13485 certification to include removal of references to legacy products and processes, regulatory updates, alignment of design control and risk management requirements for Class III medical devices, and establishment of defect classifications and AQL levels for purchased product
- Served as management representative for ISO 13485 certification audit resulting in no non-conformances
Led Change Review Board (CRB) for multiple product development and technology transfer projects for a manufacturer of blood gas and electrolyte analyzers and consumables including:
- For a line extension of an existing electrolyte analyzer and consumables, established and drove the required changes and activities for the addition of a Lactate sensor including stability testing, packaging validation, algorithm verification, and change control of over 50 impacted documents, resulting in 510K approval (K093280) and an on-time product launch.
- Facilitated activities required to transfer the manufacture of fluoroionophore, the critical component used to manufacture electrolyte sensors, to a contract manufacturer. Responsibilities included assisting with capability analysis and onsite compliance audit of contract manufacturer to ensure continuity of supply chain to meet customer demand; review and approval of contract manufacturer’s raw material suppliers; managed transfer of test methods for incoming, in-process, and final release testing; oversight of pilot run and scale up studies to establish in-process and final release specifications; review and approval of batch manufacturing instructions; managed the raw material qualification of first three (3) lots received, established incoming inspection and release criteria, and implemented inspection plans. Transfer was completed for two (2) different sensors in six (6) months reducing production backlog by 75% and decreasing Sensor chemistry operations overhead cost by 35%.
Served as core team member on project team for development of a genetic analyzer system for Laboratory Developed Testing (LDT) for an IVD manufacturer. Responsible for oversight and/or execution of the following QA activities:
- QA Reviewer and/or Approver on all required DHF project deliverables
- Ensured design control requirements were met for the product development of:
  - Consumable cartridge with semi-conductor chip for sample management and assay performance using PCR (Polymerase Chain Reaction) and HRM (High Resolution Melt) technologies
  - Assay panel for detection of four (4) coagulation disease related mutations
  - Benchtop instrument and system software for delivery of assay reagents on cartridge, regulation of PCR and HRM cycles, and results display and analysis
  - Melt analysis software for sample genotyping
- Worked with critical suppliers to establish release criteria, quality system requirements in compliance with 21CFR Part 820 and ISO13485, and quality agreements
- Resolved quality issue of cross-well contamination in assay plates resulting in change in filling specifications.
- Authored Quality Plan, Master Validation Plan, Supplier Qualification Plan and performed DHF Audits
- Helped establish assay design inputs for stability, contamination, packaging, and performance
- Developed strategy for assay and cartridge stability, packaging, transport, and storage testing in accordance with FDA requirements, BS EN 13640, and ISTA standards

PROFESSIONAL EXPERIENCE

QSN Consultant, 4/16 – Present
Canon U.S. Life Sciences, Inc., Senior Manager, Quality Systems, 7/12 – 10/15
Guided Therapeutics, QA/QC Manager, 5/11 – 6/12
Shionogi Pharmaceuticals., Senior Quality Assurance Consultant, 1/11 – 5/11
OPTI Medical, Quality Assurance Manager, 9/08 – 1/11
Life Therapeutics, Quality Assurance/Regulatory Affairs Manager, Manufacturing, 8/07 – 9/08
- Clarkston Consulting, Life Sciences Consultant, 5/05 – 8/07
- Gen-Probe, Validation Manager, 3/07 – 8/07
- GE Healthcare, Validation Manager, 10/06 – 2/07
- Stiefel Pharmaceutical, Organizational Development/Change Management, 8/06 – 9/06
- Medtronic, Quality Assurance Strategy, 7/06 – 8/06
- Chiron, Quality Assurance Strategy, 4/06 – 7/06
- Shire Pharmaceuticals, Quality Assurance Strategy, 3/06 – 4/06
- Boehringer Ingelheim Pharmaceuticals, Inc., Quality Assurance Strategy, 10/05 – 2/06
- Boehringer Ingelheim Chemical, Inc., Validation Lead, 5/05 – 9/05

EDUCATION

Master of Science, Anatomic Pathology, University of Maryland School of Medicine, 5/96
Bachelor of Science, Biology, Ursinus College, 5/93

TRAINING

Management Essential Skills, Canon, 9/14
Application of Agile Practices in the Development of Medical Device Software, AAMI, 5/14
Design Control Concepts and Implementation, Oriel Stat-a-Matrix, 10/12
Risk Management and Analysis for Medical Devices, Oriel Stat-a-Matrix, 10/12
Understanding Basic and Statistical Process Control, Global Compliance Panel, 9/11
Technical Documentation Requirements for Device Approval in EU, TUV SUD America, 8/11
RoHs 2 – Compliance with the New RoHS Directive, Intertek, 7/11
DHF, DMR, DHR, Technical File and Design Dossier – Key Requirements and Future Directions, Global Compliance Panel, 6/11
Medical Device Recalls, First Quality, Inc., 6/11
Risk-based Validation Master Plan for a GMP facility, Medmarc, 6/11
Process Improvement with Statistical Process Control, Quality Assurance Solutions, 6/10
Creating Simple, Defensible Documentation to Prove FDA Compliance, Compliance Alliance, 9/09
The Art of Communicating with Tact and Skill, Dale Carnegie, 6/09
ISO 13485 Internal Auditor, Oriel Stat-a-Matrix, 5/07
ISO 19011 Auditing Fundamentals, ASQ, 3/07
Achieving Success Through Human Relations Skills, Dale Carnegie, 1/07
Business Consulting, Clarkston Consulting, 5/06
Process and Equipment Validation, Clarkston Consulting, 3/06
21 CFR Part 11 and Computer Systems Validation, Clarkston Consulting, 6/05
Basic Principles of Computerized Systems Compliance Using GAMP4, ISPE, 6/05

AFFILIATIONS

American Society for Quality (ASQ) (Member #64102800) – 10/07 – Present
Regulatory Affairs Professionals Society (RAPS) – 10/12 – Present

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