One of Life Sciences Industry’s Leading Data Integrity Experts
• Helped FDA write original Data Integrity regulation used both domestically and internationally.
• Leading Expert in FDA regulations – worked on “both sides of the table”.
• Worked with US Government and European Governments to define Data Integrity regulations.
• Worked with Big 20 and SMB companies.
• Member of LifeSciences Think Tank to drive Data Integrity best practices for LifeSciences industry.
• Co-authored Data Integrity Book for Society of Quality Assurance (SQA) in 2022
• Co-authored Computerized Systems for Clinical Research with FDA and Drug Information Association (DIA) in 2011
• Co-authored 21 CFR 11 regulation and General Principles of Software Validation guidance with FDA and industry.
• Commenting on Data Integrity Guidance Documents for Industry
• Interviewed by Wall Street Journal (WSJ), European Biopharmaceutical Review, Healthcare Packaging
• Services include:
o Audits
o Submissions
o Inspection readiness setup and inspection support
o Set up of Systems and processes (SOPs).
o Quality Management Systems (QMS)
o Vendor Selection, Contract and Management
o Risk and Risk Management
o Program and Project Management
o Remediation following adverse inspectional or audit findings.
o Assistance in prosecution / defense
o Training
o Law firms: Data Integrity for:
Arbitration
Expert Witness
• Clients include:
o LifeSciences industry Pharma, Biotech, Medical Devices
o Gene Therapy companies
o Vendors
o Investors for LifeSciences companies
o Big 4 e.g., PriceWaterhouseCoopers
• National and International Speaker and Trainer
• Adjunct Professor at UC Berkeley
Company Details
- Founded
- -
- Address
- 675 Sharon Park Dr,
- Industry
- Biotechnology Research
- NAICS
-
Research and Development in Biotechnology (except Nanobiotechnology)
- Website
- https://touchstonetsv.com/
- Keywords
- Life Science, Consulting, Compliance, Training, Investor, Quality Assurance, Regulatory, 21 CFR 11, Computerized System Validation, IT, LAB, FDA Direct, Compliance Coach, quality, quality assurance, artificial inteligene.
- HQ
- Menlo Park, California
Touchstone Technologies, Inc. Questions
Touchstone Technologies, Inc.'s website is https://touchstonetsv.com/
Touchstone Technologies, Inc.'s LinkedIn profile is https://www.linkedin.com/company/touchstone-technologies-sv
Touchstone Technologies, Inc.'s industry is
Biotechnology Research
Touchstone Technologies, Inc.'s top competitors are
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Touchstone Technologies, Inc..
Touchstone Technologies, Inc.'s categories are Biotechnology Research
Touchstone Technologies, Inc.'s founding year is 2001
