Speaker Profile


Angela Bazigos

CEO, Touchstone Technologies Silicon Valley

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.

Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer,Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA Patent on speeding up software compliance https://www.google.com/patents/US8266578.

Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom includes training for Society of Quality Assurance.

Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford's Who's Who for LifeSciences.

  •  Friday, May 3, 2019
  • 10:00 AM PDT | 01:00 PM EDT,
  • 90 Minutes
  • $150.00
FDA's 21 CFR 11 Add-On Inspections - Recent Updates

In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.

  •  Tuesday, May 7, 2019
  • 09:00 AM PDT | 12:00 PM EDT,
  • 3 Hours
  • $290.00
3-Hour Virtual Seminar on Food Facility Inspection

The Food and Drug Administration (FDA) considers establishment inspection one of its prime enforcement tools.

  •  Tuesday, May 14, 2019
  • 10:00 AM PDT | 01:00 PM EDT,
  • 90 Minutes
  • $150.00
How to Deal with the Contradictions and Challenges of Using Cloud in a Regulated Environment

Cloud computing has become perhaps the hottest compliance topic related to computer validation and electronic records.

  •  Wednesday, May 22, 2019
  • 10:00 AM PDT | 01:00 PM EDT,
  • 90 Minutes
  • $150.00
Exploring the FDA Refuse-To-Accept (RTA) Guidance for 510(k) Submissions

The FDA has instigated a Refuse to Accept Policy and will no longer accept 510K submissions that do not meet a minimum threshold of acceptability.

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  • Recorded
  • View Anytime
  • 90 Minutes
  • $157.00
Excel Spreadsheet Validation for FDA 21 CFR Part 11

This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.

  • Recorded
  • View Anytime
  • 90 Minutes
  • $163.00
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)

This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.

  • Recorded
  • View Anytime
  • 90 Minutes
  • $167.00
FDA's enforcement of 21 CFR part 11 compliance

This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.

  • Recorded
  • View Anytime
  • $190.00
Excel Spreadsheet Validation for FDA 21 CFR Part 11

This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.

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