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, http://morflearning.com/angelabazigos/, 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 http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashxPatent on speeding up software compliancehttps://www.google.com/patents/US8266578 . Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroomhttp://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/ 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: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview.

  •  Friday, August 17, 2018
  • 09:00 AM PDT | 12:00 PM EDT,
  • 3 Hours
  • ¤290.00
3-Hour Virtual Seminar on Writing Effective SOPs

Every biopharmaceutical company has SOPs, and new staff members are told that the company "has to have them" and that each employee "has to follow them". But why do there have to be SOPs and why must we follow them as written? And how can we do this effectively?

  •  Monday, August 20, 2018
  • 10:00 AM PDT | 01:00 PM EDT,
  • 90 Minutes
  • ¤150.00
Project Management for Computer Systems Validation and 21 CFR 11 - Annex 11

Project Management is defined as the planning and organization of an organization's resources in order to move a specific task, event or duty toward completion. However, Validation of Computerized Systems has a very specific set of tasks that are often mismanaged, resulting in missed deadlines, increased costs, and regulatory risk, and missed times to market for a company's product.

  •  Tuesday, August 21, 2018
  • 09:00 AM PDT | 12:00 PM EDT,
  • 3 Hours
  • ¤290.00
3-Hour Virtual Seminar on How the FDA are Trained for Medical Device Inspections

This webinar will examine the training that FDA inspectors receive on five regulations for inspecting medical device firms.It will present the specific guidance FDA inspectors receive for each of the regulations.

  •  Thursday, August 23, 2018
  • 10:00 AM PDT | 01:00 PM EDT,
  • 90 Minutes
  • ¤150.00
Audit Trail Generation and Review

This webinar will demystify audit trails and describe the benefits of audit trail for your company. Attendees will the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.

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  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤390.00
Export Certificate for Medical Devices - Edge Out Your Competition!

In today's global environment, sustaining competitive advantage within the medical device industry involves a global product strategy that recognizes the issues involved in managing regulations across different countries. To this end, certain countries require an Export Certificate that the manufacturer and its devices are indeed in compliance with FDA regulations.

  • 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.

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Fremont, CA 94539, USA.

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