Shoreh Ershadi

Pharm.D., Ph.D., ABAAHP, NRCC, NRCT, ASCP

adwjue@r.postjobfree.com

310-***-****

**** ********* ***. *** *******, CA 90049

US Citizen

Clinical Laboratory Director & Medical Officer Medical Affairs

Professional Appointments:

Clinical Laboratory Director, City Health Urgent Care

16311 Ventura Blvd. Suite 660

Encino, CA 91436

Overseeing Clinical Laboratory Testing, SARS-CoV-2 qPCR Testing, Total Laboratory Quality Assurance. Ensuring the renewal of the Laboratory Licensing with CLIA, California and New York State.

Participation in College of American Pathologists Proficiency Program. Annual Budgeting, review and preparation of SOP’s. Validation of new tests. Developing a center for Longevity through testing for Alternative Hormone Therapy.

January 2022 - Present

Clinical Laboratory Director, Prolacta Bioscience

1800 Highland Ave

Duarte, CA 91010

Overseeing Clinical Laboratory Testing, qPCR Testing, Total Laboratory Quality Assurance. Ensuring the renewal of the Laboratory Licensing with CLIA, California and New York State.

Participation in College of American Pathologists Proficiency Program. Annual Budgeting, review and preparation of SOP’s.

Validation of new tests. Developing a laboratory for testing Mother’s Milk Donations for World Wide distribution to NICUs for premature born babies.

April 2022 – Present

Siemens Healthineers- Medical Officer -Medical Affairs

500 GBC Drive

Newark, DE 19702

Implementation and execution of In Vitro Diagnostic Medical Device Regulation (IVDR) activities through Medical Assessments of the client products. Medical consultant to project teams for preparation of IVDR performance evaluation reports. Advise on medical risks and benefits to evaluate product safety and effectiveness in laboratory medicine in support of functional group activities for commercialized/marketed products as well as for product development activities. Contribute to post-market surveillance activities in alignment with Laboratory Diagnostic policies and procedures and applicable standards/regulations. ISO 9001, 21 CFR 820 and 13485, 14971 application of risk management of Medical Devices.

July 2020- Present

ANTIAGING Institute of California, Inc.

Beverly Hills, CA 90210

President and CEO-

Management and administration of business operation, applying best practices and processes. Implementing multiple projects and objectives, conducting market competitor and customer research and assessment of opportunities. Creating value propositions and messaging strategies. Linking product launches to organizational campaign themes and goals. Great verbal and written communication skills. Frequent presenter of radio and TV programs, educational seminars, and lectures on the latest scientific developments in preventative medicine and biomarkers of health.

Formulating the highest quality health promoting nutraceuticals and cosmeceuticals with bioavailable active forms and precise concentrations and combinations for optimal function in the biochemical pathways at the cellular level within a healthy body to help prevent the physical and neuro- degenerative diseases of aging.

July 2000 - Present

Section Chief- CDPH Laboratory Field Services, California Department of Public Health

Marina Bay- Richmond CA 94804.

Responsible for licensing of Clinical Laboratory Personnel for the State of California including, Laboratory Directors, Clinical Laboratory Scientists (CLS) and Specialists, Medical Technologists (MT) and Phlebotomists. Approval and Licensing of Organizations for training of all personnel for receiving California Licensing.

2016-2018

College of American Pathologists Inspector # 22856-01 since 2001

Clinical Laboratory CLIA Director- Genova Diagnostic Laboratories - A Leader in Functional Medicine.

Asheville, NC

Overseeing Clinical Laboratory Testing and Total Laboratory Quality Assurance. Ensuring the renewal of the Laboratory Licensing with CLIA, Department of Health of New York, California and Pennsylvania as well as the College of American Pathologists. Annual Budgeting, review and preparation of SOP’s. Validation of new tests. Developing a center for Women’s Health through testing for Alternative Hormone Therapy.

2000 - 2002

Laboratory Director- Quest / Specialty Laboratories

Santa Monica, CA

Establishing the Departments of Toxicology and Automated Systems. Leading the Toxicology Department, graded the most efficient department in a high performing organization, to become one of the Nation’s most Prestigious Heavy and Trace Metal Testing Laboratories. Performing tests on HPLC, GC, GCMS, LCMS, ICPMS and other Medical Devices. Preparing biological evaluation strategies, executing testing and risk assessments. Regulatory Affairs ISO 9001, 21 CFR 820.250 and Malcom Baldrige standards of excellence. overseeing project teams, preparing biological evaluation strategies, execute testing and risk assessment activities as needed. Regulatory submissions supporting pre-clinical safety. Effectively communicate with client physicians and laboratories in oral & written form regarding test requirements, issues, deviations & special requests. Communicated with internal and external experts to assist in resolution of biocompatibility challenges. Ensured that testing meets all international & domestic test requirements according to ISO (International Standards Organization), FDA (Food & Drug Administration)-CDRH (Center for Devices & Radiological Health), ICH (International Conference on Harmonization) & GLP (Good Laboratory Practice) guidelines. Collaborated with associates of diverse technical backgrounds (chemistry, materials science, engineering, regulatory, etc.,) to achieve desired project outcomes; interact closely & providing consultative direction to R&D, Clinical Affairs, Regulatory Affairs & Supplier Management, reviewing regulatory submissions and providing input. Addition of special profiles to measure Biomarkers of Health and of Cancer for our oncologist clients. Launching the Department of Automated Chemistry, from initial start-up phase, into a full-service Laboratory offering a wide range of esoteric tests including measuring Total Antioxidant content in Whole Blood. Performing Clinical Trial testing and reporting according to protocol and validation guidelines. Effective and timely response to Client Physicians. Understanding their current needs and future expectations. Overseeing annual budgeting, preparing fiscal reports, planning, and evaluating study execution. Continuous evaluation of current SOP’s and writing new SOP’s. Continuous improvement of cost per test/panel through effective management of labor, supplies and capital expenditures. Developed and added over 250 new Diagnostic assays to the test menu.

Laboratory Director- Path Labs, Los Alamitos, CA. 1988-1995

Established a Specialized Testing Clinical Laboratory, performing oncology marker and esoteric tests promoting Women’s Health, such as CA-125, CA 15-3 and CA 19-9. Performing Clinical Testing for large Dialysis Centers.

Laboratory Director- Quest / Central Diagnostic Laboratories

Tarzana, CA

Ensured the renewal of the Laboratory Licensing with CLIA, Department of Health of New York, California, Pennsylvania and other States and the College of American Pathologists. Overseeing annual budgeting, testing and reporting accurate patient results. Developed 53 esoteric in-house tests. Continuous evaluation of current SOP’s and writing new SOP’s. Strong Customer Focus. Introducing and discussing clinical applications of newly offered tests. Continuous improvement of cost per panel through effective management of labor, supplies and capital expenditures. Ensuring Total Laboratory Quality and Safety. Overseeing Clinical Laboratory Testing (14,000 patient samples per Night). First overnight testing laboratory in US, reporting results by 6:00 am the next morning through interfaced printers in client’s offices. Total Laboratory Quality Assurance. Ensuring the renewal of the Laboratory Licensure and accreditation. Technical Director, B.P.L. Toxicology Laboratory, acquired by CDL. Prepared the laboratory to obtain DOT Licensure. Customer Focus, effective and timely response to 7000 Clients. Clinical evaluation of the newly offered tests.

1986-1988

Director- Clinical Laboratory Consultants

Providing consultation for development of the latest Clinical Laboratory Testing and Biomarkers of Health. Total Laboratory Quality Control, Quality Assurance. CAP, COLA, Ensuring the renewal of the Laboratory and Personnel Licensing with State of California and CLIA.

1994 – Present

Author of: Don’t Pause Your Life… Don’t Pause for Menopause. 45 Menopause Symptoms. 2012 Beverly Hills, CA

ONGOING MANAGEMENT DEVELOPMENT

Laboratory Director, specialist in California Code of Regulations, Title 17, DHS requirements, Joint Commission and CMS standards, OSHA guidelines, Sentinel Events and FMEA. Quality Assurance QA, CLIA, CAP, DAID recommendations of Good Clinical Laboratory Practices (GCLP) in both research/pre-clinical and clinical aspects of Good Laboratory Practices (GLP) ISO 17205 ISO 13485/2016 and 21 CFR 820.30 FDA regulations and standards including Client Laboratory Information Management System (LIMS). Highly familiar with (EU) 2017/745 regulation on Medical Devices (MDR) and Regulation (EU) 2017/746 for In-Vitro Diagnostic Devices (IVDR) and applying a high standard of quality and safety for in vitro diagnostic medical devices, ensuring reliable and robust data generation as well as providing for the safety of subjects performing and or participating in the studies. Experience in working with current Health and Longevity Market. Strong administrative and management skills, business acumen, ability to prioritize multiple projects and objectives. Ability to translate quantitative data into actionable recommendations, conduct market competitor and customer research and assess market opportunities. Ability to create value propositions and messaging strategies. Ability to link product launches to organizational campaign themes and goals. Experience in developing new clinical tests, in-depth data validations, troubleshooting and documentation. High energy team player, Judge for the California Council of Excellence. Recipient of Excellence Award, showcasing the best practices, Malcolm Baldrige National Quality Awards. Strong writing, communication, presentation development and delivery skills. Empathetic to buyers, customers and sales resources.

California Leadership Academy, Manager Development Program 2017

Professional Woman of the Year- National Association of Professional Women. NAPW VIP member attained the highest level of member ship. Recognized for outstanding leadership and commitment within the profession 2013 and 2014

Women in business Issue of Pasadena Magazine, Entrepreneur issue 2014

The Latino American WHO’S WHO recognizes, Dr. Shoreh Ershadi for her achievements in advancing the culture of the Latino American Business Community 2013

Presented Don’t Pause Your Life… Don’t Pause for Menopause book, 45 Menopause Symptoms 2012

China Health Service Industry Forum (CHSI), the 8th Annual (China) World Congress on ANTIAGING Medicine and Regenerative Biomedical Technologies Expo (A4MC), The 2nd Annual Asia-Pacific ANTIAGING Medicine Summit (APAM) 2013

Honorable Member of the A4M China, Presented the 45 Menopause Symptoms Lecture 2014

Presented a full a day workshop on “Performance Excellence” Based on Malcolm Baldrige Criteria at the AACC National Convention, Orlando, Florida 2013

VOLUNTEERING

Volunteering and supporting ISCC, the International Society for Children with Cancer. Irvine, CA.

Judge for the California Council of Excellence. Recipient of Excellence Award, showcasing the best practices, Malcolm Baldrige National Quality Awards

Chair of the Health Care Performance Excellence Program.

Co-Chair of the Health Care division of the American Society for Quality (ASQ) San Fernando Valley.

Examiner, California Council for Quality & Service and California Awards for Performance Excellence.

Administrators of the California Quality Awards. Poway, CA.

Member of the Board of Directors of Southern California section of American Association of Clinical Chemistry (AACC).

Linking Performance to success: Developing a Winning Strategy and Scorecard with Mark Graham Brown.

Six Sigma: Your Road Map to Success. Six Sigma Methods to dramatically improve customer results and financial performance with Six Sigma Tools. Six Sigma and Performance Excellence, Linking Process to Results. California Council for Excellence.

Administering the Malcolm Baldrige Quality Excellence Awards

Applying Functional Medicine in Clinical Practice provided by the Institute for Functional Medicine.

Executive EQ-Emotional Intelligence in Leadership and Organization. Robert K. Cooper

Management Course, Leadership training for Management Effective Negotiating, Facilitating and Delegating, Clinical Laboratory Management Association, management courses.

Achieving Clinical Excellence, A Functional Medicine Approach. Great Smokies Diagnostic Laboratory.

Advance training in Laboratory Information Systems, Integration, and Automation.

EDUCATION AND HONORS

Ph.D. in Clinical Biochemistry, Major in Endocrinology, Medical School, University of Newcastle upon-Tyne, England. 1980

MSc. In Clinical Biochemistry, Medical School, University of Newcastle upon-Tyne, England. WHO Scholarship. 1977

Pharm.D., Doctorate in Pharmacology, Tehran University, Tehran, Iran. (Magna Cum-Laude) 1975

LICENSES

Board Certification with the American Academy of Antiaging Medicine. ABAAHP

California, Specialist in Chemistry, License MTC485

National Registry in Clinical Chemistry, NRCC

National Registry in Clinical Toxicology, NRCT

American Association of Clinical Pathologists, ASCP

New York, Laboratory Director, License # 52054946

CAP Inspector # 22856-01

AFFILIATIONS AND PROFESSIONAL MEMBERSHIPS

American Academy of Anti-Aging Medicine

American Association for Clinical Chemistry

American Association for Clinical Toxicologists

American Association of Clinical Pathologists

American Society for Reproductive Medicine

American Heart Association

Rotarian – Rancho Park, CA.

Association of Laboratory Automation

California Council for Excellence

American Society for Quality

California Association for Medical Laboratory Technologists

California Association of Toxicologists

National Registry in Clinical Chemistry

National Registry in Clinical Toxicology

New York State Director License # 52054946 (not active)

CAP Inspector # 22856-01

HOBBIES

Sculpting, Painting, Designing, Sewing, Swimming, Hiking, Biking, Parasailing and Zip lining.

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