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Touchstone Technologies Silicon Valley

Vendor Selection & Management. We Light The Way! Vendor Selection and Management. 1811 Eaton Avenue San Carlos, CA 94070 USA.

http://www.touchstonetsv.com/

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Touchstone Technologies Silicon Valley | touchstonetsv.com Reviews

https://touchstonetsv.com

Vendor Selection & Management. We Light The Way! Vendor Selection and Management. 1811 Eaton Avenue San Carlos, CA 94070 USA.

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1

Touchstone Technologies Silicon Valley – Touchstone Technologies Silicon Valley Services

http://www.touchstonetsv.com/about

Vendor Selection & Management. Touchstone Technologies Silicon Valley Services. Touchstone Technologies Silicon Valley. Touchstone Technologies Silicon Valley Services. Touchstone Technologies Silicon Valley. Was formed in 2001 to provide expert training and consulting services. The scope of Touchstone expertise includes :. Computerized System Validation (CSV),. CSV project management and execution support,. GLP/GCP/GMP compliance program support,. Vendor and CRO/CMO assessments,.

2

Touchstone Technologies Silicon Valley – Touchstone Events

http://www.touchstonetsv.com/touchstone-events

Vendor Selection & Management. Touchstone Technologies Silicon Valley. Cosmetics How Are They Regulated? July 17th, 2014 21 CFR Part 11 Add-On Inspections by the FDA. July 22nd, 2014 Writing Effective SOPs. July 23rd, 2014 H ow to select s/w for a regulatory environment. July 23rd, 2014 21 CFR 11 Excell spreadsheet Validation. July 29th, 2014: Project Management for CSV. July 31st, 2014: Export Certificates for Medical Devices. August 5th, 2014 : SOP and FDA Compliance. 2 Dec, 2014: Writing Effective SOPs.

3

Touchstone Technologies Silicon Valley – About us

http://www.touchstonetsv.com/about-us

Vendor Selection & Management. Touchstone Technologies Silicon Valley. Pharma / Biotech / Medical Devices (Incl. Roche, Novartis /Chiron) 35 years. Positions held included position of Chief Compliance Officer. Big 4 Consulting Firm (PriceWaterhouseCoopers). Extensive experience in 21 CFR 11/CSV including prototyping of 21 CFR 11 / CSV before it was propagated to the industry. Work with FDA to create new regulations on computer systems compliance (e.g. Cloud, Mobile Devices). Chairman’s Award at Roche.

4

Touchstone Technologies Silicon Valley – Webinars

http://www.touchstonetsv.com/touchstone-events/webinars

Vendor Selection & Management. List of available webinars:. 11 February 2015: Writing Effective SOPs. 12 February 2015: Deconstructing Warning Letters – Using Warning Letters to Illustrate the FDA and Health Canada CFRs. 17 February 2015: How to write and implement a Quality Plan. 24 February 2015: Computerized System Validation: Basic Concepts. 3 Match 2015: Identification, Correction and Prevention of Human Errors in GMP Manufacturing and Laboratory Processes. 13 January 2015: Writing Effective SOPs.

5

Touchstone Technologies Silicon Valley – Seminars

http://www.touchstonetsv.com/touchstone-events/seminars

Vendor Selection & Management. List of available seminars:. 2-3 April 2015 : How to Prepare for, Manage, and Follow-up to an FDA Inspection: Risk-driven Approach: One and a Half day In-Person Seminar. 22-23 October 2015 : How to Prepare for, Manage, and Follow-up to an FDA Inspection: Risk-driven Approach: One and a Half day In-Person Seminar. FDA Warns Chinese API Makers Over Falsified Data, Improper Testing. July 13, 2016. ISPE: FDA’s Proposed Quality Metrics Far More Burdensome Than Estimated. Industr...

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