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Angela Bazigos

CEO,

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.



  •  Wednesday, October 17, 2018
  • 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.

  •  Thursday, October 18, 2018
  • 10:00 AM PDT | 01:00 PM EDT,
  • 90 Minutes
  • ¤150.00
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.

  •  Tuesday, October 23, 2018
  • 08:00 AM PDT | 11:00 AM EDT,
  • 3 Hours
  • ¤290.00
3-Hour Virtual Seminar on Analytical Method Validation Process

This webinar will explain the validation of analytical procedures for determining the suitability of a given methodology for providing useful analytical data.

  •  Friday, October 26, 2018
  • 09:00 AM PDT | 12:00 PM EDT,
  • 3 Hours
  • ¤290.00
3-Hour Virtual Seminar on Deciding When to Submit a 510(k) for a Change to an Existing Device

This presentation, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) (i.e., "existing devices") during the process of deciding whether the modification exceeds the regulatory threshold of 21 CFR 807.81(a)(3) for submission and clearance of a new 510(k).





  • Recorded
  • View Anytime
  • 3 Hours
  • ¤340.00
3-Hour Virtual Seminar on Off label Promotion of Drugs and Medical Devices - FDA's Latest

Off Label Promotion for Drugs and Medical Devices is a controversial topic which often puts FDA and industry at loggerheads.

  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤190.00
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
  • ¤190.00
Excel Spreadsheets for 21 CFR 11 Compliance

Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance.

  • Recorded
  • View Anytime
  • 3 Hours
  • ¤340.00
3-Hour Virtual Seminar on Deciding When to Submit a 510(k) for a Change to an Existing Device

This presentation, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) (i.e., "existing devices") during the process of deciding whether the modification exceeds the regulatory threshold of 21 CFR 807.81(a)(3) for submission and clearance of a new 510(k).