Patrick Stone

About Patrick Stone

My goal is to serve the global public by protecting the supply and quality of healthcare products before they enter the market place. I work towards a future where disease cures & prevention are the main goal of all new test articles. Documented 21 CFR quality & compliance experience and advocate for human subject protection. Regulatory review experience with oncology therapies for most human body systems (vulnerable patient populations included), cardiovascular disease, HIV, HCV, vaccine studies, pain management for multiple indications, in-vivo & in-vitro devices, and API & sterile drug cGMP manufacturers of biochemical and biological therapeutics. Vendor qualification & QA. FDA bioresearch monitoring (BIMO) review experience including phase I, II, clinical trials, Sponsor, CRO, GLP clinical & pre-clinical trials and for-cause compliance audits. FDA Inspectional history for regulatory and legal FDA actions include warning letters, NDA / IND revocations, drug product hold, various product seizures with destruction, and Investigator disqualification.Specialties: I specialize in IRB compliance & QA audits. Cell & Gene therapy development, cGMP, and GCP compliance. Computer system validation & 21 CFR part 11 / LIMS / Data Management System compliance, GCP, cGMP, & ICH compliance. Mock FDA drug, device, and biologic clinical trials / post market auditing.

Experience

1. Chief Executive Officer

   Tradestone Qa Llc

   Apr 2011 — Present

   Provide BIMO Quality Assurance & Regulatory consulting for CROs, IRBs, Drug, and Device companies conducting TMF, IND,NDA, 510K, IDE, PMA clinical trials. Conduct mock FDA GCP clinical site audits, vendor qualification, data-management systems audits and medical device QSIT audits (including aseptic processing). 21 CFR Part 11 compliance of your IT system and equipment validation review (Biologics, Biotechnology, Drugs, & Devices). Mock FDA audits of API & sterile biotechnology/ pharmaceutical cGMP with a detailed report of audit findings & recommendations. Provide technical support for employee training, clinical trial protocol adherence, ICF implementation process, and FDA research operation SOP\'s. We are able to also assist you with your recall audit checks (all products), Medwatch reporting, Medical Device Reporting (MDRs), and FDA compliance history (consent decrees, injunctions, or product holds). Product labeling, marketing, and social media content (Biologics, Devices, and Drugs).

Education

• The University of Texas at San Antonio

  MS, Biotechnology

  1996 — 1998

Skills

• Staff Training
• Quality by Design
• Vaccines
• Computer System Validation
• Fda Gmp
• Gxp
• Quality Auditing
• Ind
• Clinical Development
• Glp
• Regulatory Affairs
• Ich-Gcp
• Gene Therapy
• Clinical Trials
• Oncology
• Quality Assurance
• Validation
• Software Validation
• Qbd
• Clinical Research
• Capa
• 21 Cfr Part 11
• Biotechnology
• Institutional Review Board (Irb)
• Marketing Strategy
• Gmp
• Good Clinical Practice (Gcp)
• U.s. Food and Drug Administration (Fda)
• Irb
• Drug Development
• CRO
• Gcp
• Social Media
• Ctms
• Testing
• Regulatory Documentation
• Pharmaceutical Industry
• Fda