Craig A. White Email & Phone Number

Austin, TX, US

I perform functional reviews of contact lens care product documents and ISO 14155 & 11980 Gap Assessments of related Clinical Studies, all to EUMDR requirements.

I consult with Life Science firms under adverse regulatory scrutiny, those with self-identified compliance challenges and those with quality management systems requiring remediation or integration. Here are some of my recent clients.

Client manufactures and sells high performance laboratory refrigerators/freezers and plasma freezers, to EU Class IIa.I support Phase II of the client’s EUMDR compliance effort, assessing Client’s quality management system procedures, design documents and supplier processes against the requirements of EUMDR 2017/745. And ensure QMS’s conformity to ISO.

Assessed the Client's dialysis catheter product documents for conformity to the requirements of applicable new and revised Standards.

Facilitated the remediation of 11 CAPA arising from two FORM FDA 483s that resulted in a Warning Letter.

The Client designs, develops, manufactures and distributes minimally invasive medical devices for diagnostic and therapeutic procedures.I assess the Client’s Quality Management System procedures against the related requirements of the emerging European Union Medical Device Regulation, provide a written summary of my assessment results and discuss any.

The firm designs, develops, manufactures and sells surgical and non-surgical equipment to treat the leading causes of eye disease. 1) Prepared Client for compliance with the European Union Medical Device Regulation prior to the date of acceptance. 2) Generated regulatory pathway and milestones for direct product registration in Australia, Brazil and Japan..

Researched, documented and facilitated client response to FORM FDA 483 Observations regarding inadequate manufacturing processes that impact quality and inadequate CAPA documentation.

Validation project manager for emerging Greenlight Guru eQMS software. Wrote entirely new four document CAPA process, together with Work Instructions for Product Development and Internal / External Audits- all of which coordinated with and improved the related processes set forth in the emerging eQMS.

Guided the CAPA Team as part of a larger QMS transformation project. Supported the development of the team's detailed action plan and performed a gap assessment of the CAPA procedures against all applicable regulations and adopted standards. Evaluated for possible revision all CAPA Thresholds (aka Triggers, Feeders) to confirm their cross-referenced.

Supported preparation for the Medical Device Single Audit Program (MDSAP) inspections, in addition to the usual quality and regulatory compliance duties.

I consulted with Getinge's CAPA Retrospective Review against all requirements, provided a documented gap analysis and charted a path to remediation.

I reviewed, against the verification plan and design input requirements, the reports associated with an immunoassay design verification project and documented the changes necessary for report approval.

Irvine, California, US

I consulted with Biosense Webster, facilitating the Integration of their quality management system with parent Johnson & Johnson's standards.

I consulted with Medtronic Neurovascular, facilitating corrective & preventive action.

A confidential international imaging firm hired me to revise an acquired digital imaging software firm’s ineffective quality management system (QMS) to ten (10) corrective & preventive actions and to integrate the acquisition’s QMS with theirs. Audited the Design History Files and Device Master Records of three (3) software products the acquisition.

Audited their quality management system's design control processes for conformity to 21 CFR 820 QSR and ISO 13485 to inform the related remediation project. Audited the Master Design History Files for six (6) orthopaedic hip replacement product families against requirements and charted paths to remediation. Wrote or revised three (3) Health Risk.

Assigned ownership of ten (10) late, very late or nearly late corrective/preventive actions. Worked with Champions to refine their problem, containment and correction statements, and to investigate, perform root cause analysis and generate / implement their corrective / preventive action plans and effectiveness monitoring, to short dates.

Amsterdam, Noord-Holland, NL

Facilitated Philips' remediation of the quality system processes that support the production of their diagnostic imaging equipment to requirements. In addition, I provided quality and regulatory support to four (4) imaging product remediation projects, reviewing requirements, evaluating deviations, correcting defects and advising the related Change Review.

Raynham, MA, US

Facilitated Synthes’ compliance with their Corporate Integrity Agreement with the Office of the Inspector General, together with Synthes’ Global Remediation Quality Plan with Johnson & Johnson in the Product & Process Controls, Acceptance Activities-Calibration sub-system. Reviewed legacy calibration records to identify:1. Calibration failures without.

Worldwide, OO

I provided regulatory affairs and quality systems leadership to Deloitte & Touche, LLP's Life Sciences clientele:1. Facilitating the design, development and manufacture of safe and effective products2. Providing QSR and GxP quality assessment3. Implementing useful regulatory guidance4. Managing conformity to adopted standards5. Assuring compliance to.

Hycor Biomedical designs, develops and sells FDA Class 2 automated electromechanical in vitro diagnostic platforms, together with related allergy, urinalysis and autoimmune assay kits. During the original contract period ending 12/31/11, I performed gap analyses on the design history files of two diagnostic platforms and provided related design document.

After their acquisition by a private equity firm, Freedom Innovations, a prosthetic medical device firm and my direct employer for more than seven (7) years, hired me as a consultant to familiarize the new majority partner’s Regulatory Affairs and Quality Systems Manager with existing and emerging quality and regulatory issues.Projects and Results: In.

Freedom Innovations designs, develops, manufactures and sells lower-limb prosthetic devices. A. REGULATORY AFFAIRS MANAGEMENT1. I assured product and process compliance with all applicable national and international regulations and guidance, including:21 CFR 820 Quality System RegulationFDA Design Control Guidance, 1997Medical Device Directive, as.

Gunnison, Utah, US

On a consulting basis, I1. Performed final quality inspections on custom rifles for civilian and military applications.2. Performed BATFE compliance inspections to Form 4473 and provided training as corrective action.3. Developed our product performance reporting matrix.

On a consulting basis, I1. Wrote the company's original quality management system (QMS) to AS-91002. Performed and documented Internal Audits to AS-9100 and customer requirements3. Performed Management Review and defended QMS at external audit; customer and registrar4. Served as customer satisfaction specialist for a major customer

Evaluated existing manufacturing processes against related process documents and requirements. Identified performance anomalies, documented evolving efficiencies.