EDUCATION

BIO-MEDICAL ENGINEERING

University of Utah Salt Lake City

**** – 2003

DOCTOR OF PHILOSOPHY

Vladivostok State Medical

University

**** – 1999

RESIDENCY

Vladivostok State Medical

University

1997 – 1999

INTERNSHIP

Vladivostok State Medical

University

1996 – 1997

DOCTOR OF MEDICINE

Vladivostok State Medical

University

1992 – 1996

Graduated with High Honors

Chita Medical Academy,

1990-1992

CONTACT

ANDREY GRISHIN M.D., Ph.D.

DIRECTOR OF REGULATORY & QUALITY ASSURANCE

EXPERIENCE

DIRECTOR OF REGULATORY & QUALITY ASSURANCE

Golden Genesis Inc. Blood Bank / San Marcos, TX / 2016 – Present REGULATORY CONSULTANT

DragonFly Consulting / 2018 – Present

https://thedragonflysolution.com/

•Bio-Pharmaceutical Startup Experience.

•Directed mandatory regulatory process for the Biologics products requiring Federal approval;

•Handled all FDA communications as an Authorized Official, successfully accomplished an Initial FDA and AABB/CLIA Audits, initiated and finalized Biologics License Application filing.

•Assisted in developing Standard Operating Procedures to ensure Regulatory compliance with Code of Federal Regulations. and ISO 13485:2016

•Single point of contact for the multiple businesses on all Regulatory issues.

•Worked with medical and business leaders to organize, design, and present reports on quality and patient safety initiatives. Identified key points of variation or lack of reliability in processes and facilitates process analysis.

•Conducted an annual evaluation of the programs and provided Annual Report to FDA and AABB regarding patient/donor safety and quality management.

•Responsible for quality oversight of cGMP activities including setting up and/or optimizing processes for supply/material reception, product manufacturing, labeling, record review, and lot disposition, tracking & trending.

•Created, reviewed and/or approved all SOPs, forms, test methods, and other applicable cGMP documentation as a Subject Matter Expert. Directed the daily activities of support personnel to ensure that all documents are consistent with cGMP, including, but not limited to ISO 13485:2016, CMDR and 21CFR 211, 600-640,820, 1270, 1271, 42 CFR 493, 21 CFR 11.

•Provided direction for complex deviations and other investigations including CAPAs, BPDRs

•Provided status reports, including relevant quality metrics and participates in the Risk Management and Management review process;

•Oversee auditing activities to ensure that systems are operated in accordance with established SOPs.

•Establishes collaborative relationships with internal and external customers/suppliers to ensure all quality and compliance matters and any issues that arise are addressed in an open and in a timely manner. FREELANCE EDUCATIONAL CONSULTANT

Arlington, TX / 2003 - 2016

•Developed and implemented comprehensive lesson plans that accommodated a specific level of learners while offering support to make certain each student was able to grasp materials

•Provided feedback to students using positive reinforcement techniques to encourage, motivate or build confidence in students. 817-***-****

ac8rw9@r.postjobfree.com

Austin, Texas

https://www.linkedin.com/in/

andrey-a-grishin/

INTERESTS

• Traveling

• Organic Gardening

• Meteorology

EXPERIENCE (continued)

BIO-ENGINEERING ORTHOPEDIC RESEARCH ASSOCIATE

University of Utah, School of Medicine / Salt Lake City, UT/ 2001 - 2003 Research Projects:

• In vitro Analysis of Temperatures and Pressures Generated During Endosteal Reaming of the Tibia Using Stryker ® Reamer Irrigator Aspirator and Traditional Stepwise Reamers

• Analysis of Flexion-Extension, Lateral Bending and Axial Rotation in Traumatized Cervical Spines with different types of ATLANTIS® cervical plates and screws.

ATTENDING PHYSICIAN

Vladivostok Regional Hospital, Department of Particularly Dangerous Infections / Vladivostok / 1996 - 1999 Research Projects:

• Diagnosis and treatment of urinary infections caused by Yersinia Enterocolitica and Yersinia Pseudo-tuberculosis

• Problems and common complications of vaccinations for Far Eastern and Japanese Encephalitis, prevention and treatment.

• Effect of an ą-Interferon therapy on patients with HCV and HBV infection.

• Early treatment of hemophiliac patients infected with HCV using cyclosporine.

• Effectiveness of early fresh-frozen plasma (FFP) infusions in the treatment of acute bleeding and hemarthrosis of Hemophilia A patients.

• Bio-availability of Vitamins in common food groups.

• Use of pure Amino-acids in treatment of perinatal encephalopathy. ATTENDING PHYSICIAN

Children’s Regional Oncology/Hematology Hospital / Vladivostok / 1994 - 1999 Research Projects:

• Conducted examinations to the pediatric oncology patients and evaluated symptoms to determine their condition and treatment pathway, involving the German protocol treatment system.

• Reached an informed diagnosis based on scientific knowledge and the patient’s medical history

• Prescribed and interpret lab tests to obtain more information for onco-hematological conditions and abnormalities. LANGUAGES

English

Russian

VOLUNTEER WORK

• NIKE testing

• Amnesty International

• NPR

ANDREY GRISHIN M.D., Ph.D.

ANDREY A. GRISHIN M.D., Ph. D.

PUBLICATIONS

• “Analysis of Temperatures and Pressures Generated during Endosteal Reaming of the tibia Using Reamer Irrigator Aspirator and Traditional Stepwise Reamers” Higgins, K. Bachus, Casey, Grishin. Journal of Orthopedic. Salt Lake City. 2003

• “Surgical issues in Yersinia Infection” Pis’mennyi, Grishin in Klin Khir 1999

• “Cause of lethality in children with Acute Diphtheria Infection” Grishin, Erokhina, Vladivostok 1996

• “Yersinia Pseudo-tuberculosis diagnosis by using Immune-ferment analysis with Porin®”. Grishin, Malashenkova., Vladivostok 1997

• “Yersinia etiology Intestinal and Organ damage” Grishin, Beniova in Clinical Medicine Journal, S. Petersburg 1997

• “Benefits and Results of the Laser therapy of Yersinia Infection and acute intestinal infections “Grishin, Gordeets. Vladivostok 1998

• “Pathogenic model kidney infection in children with Y. Pseudo-tuberculosis” Grishin, Malashenkova. Tokyo 1998

• “Criteria of Early Diagnostic of Yesinia Pseudotuberculosis infection in children” Grishin, Malashenkova. Vladivostok April 1998

• “New methods in early diagnosis of Yersinia Pseudo-tuberculosis infection” Beniova, Malashenkova, Grishin“New methods of diagnosis and Treatment” Vladivostok 1998

• “Early diagnosis of Pseudo-tuberculosis in Children” Beniova, Grishin, Malashenkova in Homeostasis and Infectious Process. Saratov. Russia 1998.

• “Immune-enzyme analysis as diagnostic method for Yersinia Pseudo-tuberculosis infection” Gordeets Beniova Grishin. New Methods of Diagnostic and Treatment. Vladivostok 1999

• “Clinical and Epidemiological aspects Y. Pseudo-tuberculosis Infection in Far East” Grishin, Sedulina, Tokyo. April 1999

• “Pathogenic way of Treatment of the Acute Intestinal Infection and Yersinia Colitis in children” Anikina, Grishin, Sedulina in Pediatrics of XXI century, S. Petersburg. October 1999

• “Invasive investigation during diseases of the Liver/ Interventional Endoscopy in Hepatology.” Gordeets, Shapkin, Grishin. Basel, Switzerland. October 1999

ANDREY GRISHIN M.D., Ph.D.

Contact this candidate