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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
- 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
Touchstone Technology, Llc,
Triumph-Jobs-In-Europe,
Techvahi Inc.,
Manhattan Orthopedic Care,
Uniglobal Systems Llc,
Uniminds Solutions,
Touchstone Technology Ltd,
Touchstone Technologies, Inc.,
V10corp,
Winmax Solutions.
Touchstone Technologies, Inc.'s categories are Biotechnology Research
Touchstone Technologies, Inc.'s founding year is 2001
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