Expert Details

Expert in Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software

Expert ID: 730258 California, USA

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Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and India etc.

Assisted in conducting safety and effectiveness precision performance study based on FDA Class II special controls guidance document for Clinical Multiplex Test Systems.

Developed and executed regulatory strategy and achieved successful Letter to File strategy for second generation of Clinical Multiplex Instrumentation systems.

Authored FDA Pre-IDE, IDE plans, protocols and reports for Reagents and Cytogentics products. Setup and follow-up on FDA regulatory meetings based on Title 21 CFR Part 812

Provided guidance and reviewed expression profiling reagents clinical trial protocols, site preparation plan, training, reports and ensured that they adhere to GLP (FDA 21 Part 58) and GCP (ICH E6)

Responsible for yearly renewal of FDA Product and Establishment Registration as per Title 21 CFR Part 807, Health Canada, State of California and other global registrations

Authored EU Technical File, Essential Requirement Checklist, Declaration of Conformity documents for Clinical Multiplex Test System and Expression Profiling Reagents Diagnostic products.

Provide guidance, oversight and QC of reagents adhering to Good Manufacturing Practices (GMP) and Chemistry Manufacturing Controls (CMC).

Co-ordinated and provided extensive feedback on Expression Profiling Reagents Kits Stability Studies (accelerated, real time, open vial, freeze-thaw etc.) to assign shelf life and expiration date.

Co-authored Traceability Matrix for the products from user requirements to design requirements to verification and validation protocols to risk id.

Assisted and Reviewed product labeling like container, box, package insert, user manuals, material safety data sheet and marketing literature (advertising and promotions) before release.

Managed Corporate, Manufacturing Sites, Authorized Representative (Europe, Mexico, China) Site Registration and Medical Device Listing.

Assisted partners to achieve FDA clearance for Metabolic and Cancer Assays

Oversaw and assisted the establishment, maintenance and performance of the company quality system for medical device product lines based on FDA QSR Title 21 Part 820, 11, 58, 210, 211, ISO 13485, ISO 9001, ICH E6
Assisted QA/RA team in achieving the ISO certifications with TUV for corporate and manufacturing sites

Lead several Corrective Action, Preventive Action (CAPA), Nonconforming Material Report (NCMR), and Deviations teams and ensured successful closure. Assisted and monitored the process validation and process capability of the preventive actions.

Ensured there is continuous improvement in the entire Enterprise Quality Management System in the area of Procurement (Supplier Quality), Manufacturing (Internal Quality) and Distribution (Customer Quality) and addressed on-going issues.

Conducted as Lead Auditor audits of several companies like PA Consulting, Ingenuity, Iconix, Parallele, RND Group, Critech, Roche, Salesforce.com, Asuragen, NEB Bioscience, Clonetech, Dextrys, Metric Stream, Trackwise, Taleo, Cornerstone etc.

Created Supplier Quality Assurance Plans and Reviewed Supplier Contracts and Quality Score

Assisted and conducted several internal audits of product development, customer support, marketing communications, IT, operations and manufacturing departments.

Project lead to automate the job description, training and performance of the entire corporation.

Authored Product and Software Life Cycle Procedure and associated templates

Array

Providing regulatory affairs and quality assurance consulting services to the Medical Device, Pharmaceutical, and Biotech.
Created with team regulatory affairs and quality assurance related products like QSM, EDMS, ECOMS, NCMR, CAPA and Deviation.
Created with team pre-packaged software testing, verification and validation suite for Sharepoint, Salesforce, JD Edwards, Oracle and SAP.
Created Document Authoring Tool for Regulatory Submission and Documents like Front End Doc Template Tool, eCTD templates, Medical Device Templates.
Provided RA/QA support and oversight to project core team during new product design, development, validation and post launch of both Medical Diagnostic Device and Research Use Only (RUO) products. Lead and developed regulatory plan and strategy for Clinical Multiplex Molecular Diagnostic System. Assembled with team regulatory submission and obtained 510(k) clearance, ISO 13485 IVD CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and India.

Oversaw and assisted the establishment, maintenance and performance of the company quality system for medical device product lines based on FDA QSR Title 21 Part 820, 11, 58, 210, 211, ISO 13485, ISO 9001, ICH E6 Assisted in product development and testing of CELL-DYN 4000, a 32 parameter, high volume Hematology Analyzer System. It produces 110 CBCs per hour on less than 120 µL of blood sample. Output results are components of whole blood, including red (RBC) and white blood cells (WBC) and platelets (PLT). These tests are a basic measure of health and are some of the most commonly ordered blood tests in the laboratory

Expert may consult nationally and internationally, and is also local to the following cities: San Jose, California - San Francisco, California - Sacramento, California - Oakland, California - Stockton, California - Fremont, California - Modesto, California - Salinas, California - Santa Rosa, California - Hayward, California

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Education

Year Degree Subject Institution
Year: 2008 Degree: Master of Science Subject: Regulatory Affairs Institution: SDSU
Year: 1988 Degree: Master of Science Subject: Electrical Engineering Institution: LSU
Year: 2003 Degree: Bioinformatics Certificate Subject: Bioinformatics Institution: Stanford

Work History

Years Employer Title Department Responsibilities
Years: 2007 to Present Employer: Undisclosed Title: Regulatory Affairs and Quality Assurance Consultant Department: Regulatory Affairs and Quality Assurance Responsibilities: Providing regulatory affairs and quality assurance consulting services to the Medical Device, Pharmaceutical, and Biotech.
Provide regulatory affairs and quality assurance related products like QSM, EDMS, ECOMS, NCMR, CAPA and Deviation.
Provides pre-packaged software testing, verification and validation suite for Sharepoint, Salesforce, JD Edwards, Oracle and SAP.
Provides Document Authoring Tool for Regulatory Submission and Documents like FrontEnd DocTemplate Tool, eCTD templates, Medical Device Templates.
Years: 2002 to 2011 Employer: Affy metrix Title: RA/QA Manager Department: Responsibilities: Lead and developed regulatory plan and strategy for Clinical Multiplex Molecular Diagnostic System. Assembled with team regulatory submission and obtained 510(k) clearance, ISO 13485 IVD CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and India
Oversaw and assisted the establishment, maintenance and performance of the company quality system for medical device product lines based on FDA QSR Title 21 Part 820, 11, 58, 210, 211, ISO 13485, ISO 9001, ICH E6
Years: 2001 to 2002 Employer: Ligand Pharmaceuticals, Title: Regulatory Affairs Consultant Department: Clinical Research Responsibilities: Assisted in conducting Auto Immune Disease research and subsequent data analysis and result interpretation
Regulatory Affairs
Co-authored Informed consent and Institutional Review Boards (IRB) Regulatory requirement document for clinical studies with the UC Davis Doctors.
Years: 1995 to 2001 Employer: Abbott Diagnostics Title: Product Development and Regulatory Affairs Consultant Department: Medical Device Responsibilities: Assisted in product development and testing of CELL-DYN 4000, a 32 parameter, high volume Hematology Analyzer System. It produces 110 CBCs per hour on less than 120 µL of blood sample. Output results are components of whole blood, including red (RBC) and white blood cells (WBC) and platelets (PLT). These tests are a basic measure of health and are some of the most commonly ordered blood tests in the laboratory.
Assisted in product development and testing of HEMATOLOGY WORK CELL (HWC) system, focused primarily on high volume blood sample testing with auto re-routing of samples based on test results to do further retesting. HWC System consists of Navigator Data Station, maximum of 4 CELL-DYN 4000 Systems, 2 SMS Slide Maker/Stainer, 1 CC – Conveyor Controller, 1 Web Based RV - Results Viewer with sampling rate of 400 CBC’s per hour.
Assisted in optimizing the assay protocol to get the complete blood results in few minutes from half an hour.

International Experience

Years Country / Region Summary
Years: 1983 to 1986 Country / Region: India Summary: Regulatory Affairs Apply for regulatory clearance from Indian Government to sell the products in India. Assisted company in labeling and advertising of the products. Customer Service & Support Service and Support of Electrocardiogram (ECG), Electroencephalogram (EEG), Electromyography (EMG), Pacemaker, Defibrillator, Lung Vita Test, Heart Valves etc. Medical Devices

Career Accomplishments

Associations / Societies
Professional Activities:. Active member of the American Society for Quality (ASQ), Regulatory Affairs Professional Society (RAPS), Institute of Electrical Engineers (IEEE).
Licenses / Certifications
AMA (MBA), RAC
Professional Appointments
Biomedical Course Coordinator for ASQ Silicon Valley Section 0613.
Advisory Board - University of Santa Cruz Extension
Awards / Recognition
Honors: Author of two books and several articles published in RAPS Regulatory Focus magazine. Consistently received far exceeds expectations award in the companies worked. Recognized by the Affy max President in Quarterly Employee Meeting for outstanding work on medical device products.
Publications and Patents Summary
Papers, Publications:

1. Electronic Submission for Medical Devices in the US and the EU
Article on electronic submission for medical devices in the US and the EU. Article published in RAPS Focus Magazine
2. Electronic Signatures and Digital Certificates in the US
Article on Electronic Signatures and Digital Certificates requirements in the US. Article published in RAPS Focus Magazine
3. Electronic Regulatory Submissions Gateway in the US and EU
Article on Electronic Regulatory Submissions Gateway in the US and EU. Article published in RAPS Focus Magazine -
4. Interview by Pharmaceutical Processing magazine on Electronic Signatures and Data Quality
Article on data quality and records integrity in regulatory submission
5. Regulatory Management Simulation: "Strategic Regulatory Planning for Innovative Medical Devices and Diagnostics
White paper providing an overview of the In Vitro Diagnostic Device (IVD) Protein Diagnostics regulatory plan to get the FDA approval. Subsequently company will apply for approval and market the product in EU, Japan, Canada and rest of the world.
6. Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices
White paper provides guidance on the regulatory content and review of pre-market submissions for software contained in medical devices. This paper explains the software level of concern determination and how it relates to device hazard analysis & risk mitigation including documentation requirements. It discusses Risk Management activities associated during software development.
7. The Manufacture and Control of Chemical and Biologic Active Pharmaceutical Ingredients (API’s).
White paper on Addressing Compliance to Current Good Manufacturing Practice (cGMP).
8. Comparing Regulatory/Clinical Trial Similarities and Differences between the EU and Japan
White paper on Comparing Regulatory/Clinical Trial Similarities and Differences between the EU and Japan.
9. Due Diligence Audit Preparation
White paper on how to prepare a biotechnology company supporting phase I, II clinical trials doing all clinical supplies manufacturing and testing internally for due diligence audit from potential partner.
10. New Drug Product Development Plan
White paper on APC 1000 drug product development plan to demonstrate efficacy and providing evidence of the safety in the study population and subsequently to the FDA approval of a new drug product.
11. Tools and Technologies for Electronic Submissions
Article on plug-ins, file system, servers, EDMS and publishing systems required for Electronic Regulatory Submissions for medical device and drugs.
12. Electronic Submission Choices, Challenges and Solutions
Article on global or national submission, regulatory document management, tools, technologies, personnel and life cycle requirements.
13. Medical Device Adverse Event Reports and Drugs Post-marketing Adverse Events Reporting
Article on logistics related to medical device and drugs adverse event reporting.
14. Consent Decree Paper
White paper on the Consent Decree against Schering-Plough Corporation, with a disgorgement fine of half a billion dollars by FDA and as to what steps the company should have taken to avoid consent decree.
15. How to handle FDA Warning Letters Issued to Biologics, Drug and Medical Device Companies?
White paper on Warning letter issued to biologic, drug and medical device company in last 24 months and how they could have prevented the action from the regulatory agency.
16. HIPAA Health Insurance Reform and Electronic Health Record Implementation
White paper on HIPAA implications on clinical research, industry approach, challenges and relationship to FDA guidance on electronic records and signatures.
17. Electronic Regulatory Submissions and Review for Drugs and Medical Devices
Co-author - book on electronic regulatory submission and review for drugs and medical devices.

Additional Experience

Expert Witness Experience
FDA, ISO and State Audits of Medical Device Facilities
Training / Seminars
Instructor and Biomedical Course Coordinator for ASQ Silicon Valley Section 0613.
Software Risk Assessment, Verification and Validation for Regulated Industries.
Managing Corrective Action and Preventive Action, Non Conformance's and Deviations

Instructor University of California Santa Cruz Extension - Medical Device Design Verification and Validation.
Conducted training/seminar/workshop classes in the area of Risk Management, Design Control, Verification and Validation, Software Lifecycle Process, Regulatory Electronic Submission, GLP, GCP, HIPAA, Advertising, Promotions and Labeling, Corrective Action and Preventive Action (CAPA), Nonconforming Material (NCMR), Deviations, and Complaint Management and Adverse Event Reporting.
Vendor Selection
Auditing: Performed audits of many suppliers based on FDA QSR Title 820, Part 11, 210, 211, ISO 13485, ISO9001, GLP (Part 58), GCP (ICH E6), Software Life Cycle (IEC 62304, GAMP) etc.

Conducted as Lead Auditor audits of several companies like PA Consulting, Ingenuity, Iconix, Parallele, RND Group, Critech, Roche, Salesforce.com, Asuragen, NEB Bioscience, Clonetech, Dextrys, Metric Stream, Trackwise, Taleo, Cornerstone etc.

Language Skills

Language Proficiency
Hindi
French
Gujarati
Sanskrit

Fields of Expertise

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