Quality to Market

Project Management, Software Quality, and FDA-regulated validation services for pharmaceuticals, medical devices, biologics, and biotech organizations.
Investment Strategies for Stock Option Trading.

   Providing order to complex challenges
   

     Consultants

 Consultants
D. Norman Perkins

Chief Investment Strategist and Principal Consultant Mr. Perkins is a PMP certified project manager and certified software quality engineer with over 20 years experience in leading major projects, especially in FDA regulated Pharmaceutical, medical device and biotech companies. He has special emphasis and expertise in computerized laboratory and quality systems. Proven ability to direct successful projects and programs. Strong technology and change management background, highly familiar with business development and business process re-engineering operations. As the co-author of the "LIMS Workbook -- A practical guide"., with book sales in five countries and used in part by the American Society for Testing and Materials (ASTM), co-authored the "LIMS Workbook -- A practical guide", Norman has extensive experience in all phases of Laboratory Information Management Systems. Providing internal process consulting on international trade, computer science, chemistry and e-Business for Sociètè Gènèrale de Surveillance (with projects in the U.K., Switzerland, USA, Russia, Ukraine, Netherlands, Spain and Cameroon),

     Project/program management (GMP and non-GMP environments), PMP certified
     Information systems project and program management
     Software quality and validation, ASQ CSQA certified
     Quality systems and compliance consulting for medical device and pharmaceutical industries
     Strategic and tactical organizational consulting to senior managers
     Business progress re-engineering
     Laboratory Information Management Systems (LIMS), including LabWare certification
     Manufacturing equipment and facility qualification
     Computer systems and automated process controls validation and training
     Laboratory instrument qualification, calibration, and maintenance
     Vendor and supplier audits
     Gap assessments

Norm's extensive professional career has included work and study in over 30 countries. Norman received his Master of Business Administration (MBA) from the University of Colorado and BSc in computer-aided Chemistry
   softwarevalidation.com , Hounds Tooth Inn

Mike Hadaway
30+ years experience in the design and application of industrial control systems and instrumentation in multiple industries, DCS system hardware, software development & configuration, FDA validation, regulatory oversight, and remediation.
Technical Skills-Industrial Control System Configuration:
     Emerson DeltaV
     Siemens S7, PCS7
     Honeywell TDC 3000
     Moore Procidia
     Intellution, Wonderware HMI
Specialties:
     Relational databases
     DCS System hardware, bus topology
     Ability to scope projects and successfully deliver on schedule

John M. Rogers, Chief Development Officer
John Rogers has an extensive awareness of and experience in B2B e-commerce and trade services in international multicultural and risk management environments.
Formerly, John was President & CEO of the Bermuda based TradeTrust Ltd. And prior to that, Senior Vice President of Societe Generale de Surveillance S.A., Geneva. His extensive career with the SGS Group included senior
executive positions in Canada, Colombia, South Africa and Japan related to commodity trade and risk management services. Prior to SGS, John was employed in various capacities with Rio Tinto (CRA) and Broken Hill Pty Ltd, in the
areas of mining and steel manufacturing. He received his degree in Chemical Engineering from the University of New South Wales, Australia.

Pete Smeal, Chief Technology Officer
Over 22 years professional experience in the field of computer technology. Skillful in trouble shooting, analysis, design and modification of software and database products. Have worked on all aspects of the software life cycle;
from conceptual documentation and analysis, prototyping and component testing, final production, alpha and beta testing and final release. Methodical and tenacious when trouble shooting and maintaining mature software. Clients
include Unocal Molycorp, Lear Siegler, Mishra and Associates, Custom Instrumentation Services Company, Food Manufacturing Processes Inc., American Council of Independent Laboratories (ACIS), Insurance Shopping Network
(ISN), Gates Rubber Company, SoftRisk Technologies Inc., Coors Brewery, Kebbler Company, and Nine One One Inc. Pete received his BSc Chemical Engineering from the University of Colorado at Denver.

Alfonso C. Fuller, Jr
Affiliated Consultant Mr. Fuller specializes in quality system, regulatory, enforcement and compliance matters for FDA regulated medical device, pharmaceutical and biotech manufacturers, suppliers, importers and vendors. Having practiced in Washington, D.C., Mr. Fuller is highly experienced in communicating with FDA headquarters and field staff. Mr. Fuller has specialized in regulated industry for over 25 years.

Quality System Consulting

cGxP, GMP, GLP, GCP, GAMP audits, compliance and remediation
Program and project manager for many Fortune 500 manufacturers
Interpretation and implementation of 21 CFR Part 11, 58, 210, 211, 820, etc
Seminar speaker and trainer (public and on-site training available)
Vendor / supplier audit and training
Computer Systems / Software Validation
Computer systems programmer, tester, validation engineer
Systems inventory, audit, gap analysis, implementation, remediation
Software quality auditor, reviewer, SQA manager
FDA Compliance and Enforcement
Response and prevention regarding FDA compliance and enforcement matters
Pre-audit preparation and post-audit response
FDA enforcement and compliance expert: FDA-483, warning letter, consent decree, seizure
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ADVISORY BOARD OF DIRECTORS

Len Cordiner

Leonard Cordiner - Management Consultant. Len was the Chief Executive officer for Meet World Trade and Senior Vice President and Head of E-Commerce for Societe Generale de Surveillance (SGS), the world's largest third-party
quality assurance company. Prior assignments with SGS included Director of the SGS Project Resourcing Services Sector; Chief Executive Officer SGS Australia Pty., Ltd.; Chief Executive Officer SGS Nigeria Pty., Ltd.; and Vice
President SGS Far East Ltd. He is a member of the Royal Australian Chemical Institute and a Fellow of the Australian Institute of Company Directors. He was President of the Swiss Australian Chamber of Commerce, a
member of the Australian Prime Minister's Supermarket to Asia Task Force, and Sydney Coordinator of the Agenda 2000 Forum.
   Len Cordiner - TIME ,Worldhotel-link.com

Jerry Hellmann
Jerry Hellmann is the Senior Vice President for DeVry Institutes. Jerry's prior assignments include Chief Development Officer for Global Fiduciary Trade Services, Vice President and Program Director for Bank One. He has
twenty years experience in developing and directing multimillion-dollar programs in the financial services industry across a broad range of architectures and offshore facilities.

Norman Powell
Retired President of SGS Control Services, Inc / SGS Redwood Petroleum and Petrochemical Services; Regional Sector Manager, Americas; National Chief Executive Saudi Arabia, Management at Elles Mere Port, U.K. and
others.

D. Norman Perkins
Managing Director. See above.

John M. Rogers
CDO Q2 Marketsite. See above.

Rowan Smith
Rowan Smith has a mining and financial background with 16 years collective experience in the minerals management and merchant banking sectors. Rowan previously worked for Rand Mines as a mine valuation
geologist. He then joined SGS where he held position as General Manager for their South African resource operations and was later seconded to join SGS's minerals management team in Switzerland. Rowan then joined
Investec Bank's Resource Finance division nearly four years ago and holds a Bachelor of Science in Geology with Honours and a Bachelor of Commerce with Honours.


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