FDAGlobal

President and owner of a scientific consulting company, focusing on the scientific and regulatory aspects of the health care industry. Nationally recognized in the field of Ethylene Oxide Sterilization and sterilant residue analysis for medical devices. Various projects have focused on the development of scientific position papers and data evaluation systems for optimizing decision making, designing of paperless documentation systems, and strategic assessment of regulatory submissions to FDA. Extensive experience in GMP/ QSR/ GCP/ GLP audits of Companies and suppliers (vendors), both nationally and internationally, specifically for preparation of FDA audits. Experience includes various national position papers and development of guidelines for the sterilization of medical devices, the design of drug stability studies, DMF/IND/NDA/510k/IDE/PMA submissions, and clinical protocol development projects.

Recognized expert and lead auditor in sterilization and sterilization protocols and studies, in conformance with EC (EN)/ ISO / FDA guidelines and requirements, including extensive knowledge and lead auditor experience in ISO 9000, EN 45001, ISO 13485, and 93/42/EEC (Medical Device Directive). (Refer to section below).

Albert Rego, Ph.D. also operated as a defacto scientific advisor to ISO TC/194 WG-11with regard to the elements and guidelines of Ethylene Oxide Residues through his advisory capacity in AAMI and his efforts in the revision of the ISO 10993:7 Residue Guidelines.

Ownership: 100%

Albert Rego, Ph.D. has been teaching two courses in support of professionals in the medical device and pharmaceutical industries on a steady basis since 1999. The two courses include - Quality Control Systems in the Medical Device Industry and Manufacturing in the Medical Device Industry.

Currently the course Quality Control Systems in the Medical Device Industry is provided as a lecture format as well as an on line course offering. The course Manufacturing in the Medical Device Industry has been provided in a lecture format and is undergoing conversion for use as an on line course.

One recent course has been offered in 2006 concerning Combination Products (products that have the features of both a medical device as well as a pharmaceutical, where two different sets of Federal Regulations can apply to the product approval and legal sales/ distribution in the United States and its possessions).

Vice President Regulatory Affairs/ Quality Assurance and Science Applications, with responsibility for all aspects of NIOSH, EPA, Health Canada, Australia, EU, and FDA filings of antimicrobial devices, including respirators, catheters, gloves, and surgical apparel. Active corporate sites include Mirabel, Canada; Burlington, Vermont; Ipoh, Malaysia; and San Diego, CA (headquarters). Achieved two EPA site licenses, EPA registration (FIFRA exempt antimicrobial) at Federal level and in 49 of 50 States (sans CA due to excessive testing costs). Achieved 510k approval of respirator and seven different respirator N95 NIOSH approved (certified) configurations. Obtained European CE Mark for medical device respirators. Achieved three sites (manufacturing) license registrations with Health Canada. Achieved mask and respirator filings and approvals from Health Canada.

Responsible for maintaining all aspects of Quality Control and Quality Assurance for all corporate sites, under BSI Certified ISO 13485:2003 Quality System. Achieved enterprise wide ISO 13485:2003 certification in 2008.

Responsible for 'edge of the art' applications of antimicrobial with medical devices, with current result of patent application for urinary catheters with antimicrobial and biofilm control/ reduction.

Continued involvement with the ASTM in conjunction with FDA (Infection Control) representatives on glove/ antimicrobial committee D11.40.

Albert Rego, Ph.D. is a Principle Founder, Board Member, and Chief Regulatory Officer for QSOne, Inc., an Arizona based Corporation based in Mesa, Arizona.

QSOne's mission is to open medical device markets to our clients. Our services are comprised of all the steps needed to reach worldwide markets. From FDA and EU regulatory assistance to contract manufacturing to EU warehousing and representation, QSOne, Inc. is an all-inclusive partner. Our services include: Establishment Registration, FDA regulatory assistance, Device registrations, quality systems, contract manufacturing and Tooling and Engineering in Injection Molding arena.

Ownership: (none - recently divested ? continuation through Single Activity Agreements only)

Albert Rego, Ph.D. is aligned with 'medical device certification' GmbH (mdc), a notified body located in Munich, Germany, as a lead auditor for the Council Directive (93/42/EEC). The company 'mdc' GmbH is certified to all annexes of the European Medical Device Directive 93/42/EEC and is certified to provide CE Mark certification for all non active medical devices. Albert Rego, Ph.D. has performed over 100 audits for various companies including Johnson and Johnson and Becton Dickinson, to name a few.

Albert Rego, Ph.D. is a recognized lead auditor for ISO 9000:2000, ISO 13485:1996/2003 (ZLG Certifying Body ? QZert Moody, Munich- Germany: #DE812169576) and the Medical Device Directive - 93/42/EEC ('mdc' GmbH - Germany) and is a key contact for all North American activities for 'mdc'.

Albert Rego, Ph.D. may operate as a consultant to assist organizations in the preparation of systems and documents in accord with the requirements of the EEC, or can operate as an extension of 'mdc' in the certification process. In order to avoid all conflicts of interest, Albert Rego, Ph.D. can only engage in activities with a given Company in one, but not both of these activities.

As a lead auditor, Albert Rego, Ph.D. is directly responsible for reviewing certification to ISO 9000, and the MDD (CE Mark) for over fifty company product families. As a consultant, Albert Rego, Ph.D. has successfully prepared over fifty company documentation packages/ files for certification, without a single denial of certification.

Ownership 100%

President and owner of a laboratory involved in the clinical, chemical, microbiological, and regulatory affairs support functions to the health care industry. Major clients throughout the United States utilize our services for purposes of studies and submissions to the Food and Drug Administration in the area of Pharmaceuticals and Medical Devices. Regulatory affairs support includes International audit participation for certification of various facilities to International Standards Organization (ISO 9000), European standards (EN46000), and for certification to the European CE mark through compliance with the European Medical Device Directive.

Ownership: (none - recently divested)

Group Manager of Divisional Laboratories with all scientific responsibility for chemistry, toxicology, microbiology, and sterilization for a $500M - $600M sales division. Promoted from Manager of Chemistry. Implemented paperless information technologies, refined medical device testing protocols, established chemical hygiene programs, and established all chemical and biological specifications for manufacturing sites both domestically and internationally.

Held three positions with two promotions from Manager of Materials Research through Director at CILCO, an intraocular lens manufacturer. Directly responsible for achieving approval of the first UV absorbing Intraocular lens. Recruited directly into Ioptex Research as Vice President of Research and Engineering. Championed the first flexible PMMA lens for the industry, resulting in a major lens patent. Responsibilities included all lens research programs and engineering developmental projects for manufacturing.

Held three positions with two promotions from Staff Chemist through Research Section Manager. Responsibilities included pharmaceutical stability programs, direct support for regulatory submissions, and analytical chemistry research for new product concepts. Achieved the first three dimensional representation of chromatographic peaks, now used as a direct method for validating stability study specificity. Responsible for the implementation of a dual promotional ladder for managers and scientists. Direct involvement of planning for 27,000 sq. ft. chemistry research facility. Championed and implemented the purchase of over $1MM in research grade chemical instrumentation.

Staff chemist, for the Bar Soap and Household Division with responsibility over new method development for direct marketing support and research projects.

Level: Pre and Post BA, BS

Multidisciplinary course designed to consolidate all previous MBA courses in a single management project (Research study/ report)

Director and Vice Presidential level Corporate personnel in Medical Device Companies -(Executive Training Course) Co-developed a complete multiple course outline. Lectures on multiple courses for Regulatory Management throughout the United States.

International scientists and International Corporate Officers - "How to Comply with Different GMP Regulations: Practical Experience with Different Inspection Systems"

Management and Professional level - President/CEO and direct reports - Primarily focused on corporate preparation for ISO 9001 and CE Mark certification

Director and Vice Presidential level representatives from various national and international medical device companies - multiple lectures on Ethylene Oxide to National Committee Forum.