Dr. Michael J. Dreikorn is an Aviation, Space and Defense industry Quality and Regulatory Compliance Expert. Dr. Dreikorn has extensive experience, having held positions such as VP Quality and Product Integrity at Pratt & Whitney; Deputy Division Manager of the Production and Airworthiness Division of the FAA, and other notable leadership and technical positions. His aircraft familiarization includes space vehicles, general aviation, commercial transport, and military aircraft, for both fixed and rotor wing applications.

Areas of Expertise Include:

Accident Analysis / Investigation / Prevention / Reconstruction Aircraft Maintenance / Manufacturing Alternative Dispute Resolution AS9100 and quality standards Business Organization Document Examiner DoD Procurement Rules Due Diligence Engineering Quality Assurance Evidence Protection

Expert Witness Testimony FAA Regulations False Claims Against the Government Human Factors Laboratories Management Responsibility Professional Malpractice Professional Responsibility Regulatory Compliance Safety Management Systems

Siegfried Guggenmoos, B.Sc.(Agr.), P.Ag., Principal of Ecological Solutions, Inc. is a Professional Agrologist, with over 30 years of experience in the electric/gas utility corridor vegetation management business.

Mr. Guggenmoos has designed, implemented and provides assessments of utility vegetation management programs. In evaluating the prudence of vegetation management programs Mr. Guggenmoos has developed methodologies to assess their efficacy by predicting the impact of vegetation management program as practiced, on the future costs and reliability of electric systems.

Areas of Consultation:

• Storm hardening electric transmission and distribution systems to quantitatively manage tree-caused service interruptions
• Advise and develop protocols for assessments of power line tree exposure and mitigation
• Advise on least cost vegetation management by synchronizing economics and ecology
• Advise on impacts of vegetation management program alternatives, modifications
• Provide context for vegetation management, greenhouse gas mitigation measures in a competitive energy market
• Facilitate for management, staff, contractors and stake holders an actionable understanding of ecological principles and their impacts on vegetation management needs and costs
• Provide project management; expert review of programs and proposals
• Develop and advise on quantification, monitoring and verification of biotic greenhouse gas mitigation measures

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Michael H. Anisfeld has over 35 years experience with pharmaceutical and healthcare manufacturing companies in the US and overseas, working in all aspects of Production, Quality Control/Quality Assurance, Regulatory Affairs and Supply Chain Management He provides expert testimony relating to all aspects of compliance to Good Manufacturing Practices (GMPs) impacting the manufacture and testing of pharmaceuticals, biotechnology products, and Active Pharmaceutical Ingredients (APIs).

Mr. Anisfeld has provided articulate "expert" testimony in federal and state courts as well as in international courts/arbitrations on GMP and Supply Chain Management related cases. He has a thorough knowledge of FDA regulatory enforcement activities, and has worked with companies in trouble with FDA and other authorities to strategize quick and cost-effective recovery.

An active member of several key pharmaceutical industry professional groups (FIP, ISPE, PDA, RAPS, TOPRA) in the USA and Europe. Having served on their boards and management committees, he is very well known and respected in the industry and with regulatory agencies worldwide.

Mr. Anisfeld is a regular columnist on GMP-related matters for US and European professional journals, as well as being an author and a frequent lecturer on GMP topics.

mdi Consultants, Inc - Experts in FDA regulatory affairs, quality assurance and ISO 9000 certification. With 6 years in the FDA and 26 years consulting to the industry, mdi Consultants, Inc. has been an invited Speaker worldwide on FDA regulations and policies and has obtained FDA expert status as third party auditors.

OUR APPROACH

We utilize the following three part approach to providing high quality services to our clients:

Unsurpassed consultant experience – we identify and recruit only top quality consultants with deep industry knowledge to provide the most complete and insightful advice to our clients

Up-to-date systems and processes – we have highly defined systems (e.g. manuals, training programs, technical files) and processes (e.g. audit methodologies, 510(k) submission, validations) that are constantly refined and kept current across the ever changing regulatory environment

Involvement in regulation development – we stay ahead of policies by participating in the development of regulation (e.g. HACCP, Scientific Advisor to U.S. Congressmen)

Northern California Office: 1085 Wright Street Mountain View, CA 94043 T: (650) 793-2809

Southern California Office: 270 Caldera Street Perris, CA 92570 T: (951) 238-2118

Dr. Andrew Perry, Professional Engineer, is the President of New World Consulting Service, an International Corporate Consulting company dedicated to assisting hi-tech companies in developing Global Quality Management Systems. He has over 30 years of experience in Engineering Management, Quality Management & Assessment, Design and Manufacturing Guidance.

Dr. Perry has been an Expert Witness and Technical Consultant for matters involving the following:

• ISO / AS Quality Management Systems
• Business Processes
• Medical Devices / Instruments
• Electronic, Electromechanical and Mechanical Hardware for High Production
• Aerospace and Nuclear Projects
• Microcomputer Memory Systems and Computer Peripherals
• Satellite Telecommunications Antennas
• ASICs Sensors and Silicon Microstructures

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