Speaker Profile


Angela Bazigos

CEO, Touchstone Technologies Inc

Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in the Life Sciences & Healthcare Industries. Her background includes companies like Roche, Novartis, Genentech and PricewaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA.  

Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to Life Science Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediation following action by the FDA. Has contributed to prototyping of 21 CFR 11 & CSV before promulgation to industry.

Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia.  She holds a patent in speeding up software validation. She has been on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Life Sciences industry.


 How the FDA are Trained for Medical Device Inspections
How the FDA are Trained for Medical Device Inspections

Speaker:Angela Bazigos
Time: 2nd April 2019 09:00 AM PDT | 12:00 PM EDT
Duration:180 Minutes
Model : MDAQ-9159

Tue
02
Apr 2019

Audit Trail Generation and Review
Audit Trail Generation and Review

Speaker:Angela Bazigos
Time: 10th July 2019 12:00 PM PDT | 03:00 PM EDT
Duration:90 Minutes
Model : FDAQ-9149

Wed
10
Jul 2019

CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations
CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations

Speaker:Angela Bazigos
Time: 25th March 2019 10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Model : FDAQ-9177

Mon
25
Mar 2019

Data Integrity – FDA’s Latest Thinking
Data Integrity – FDA’s Latest Thinking

Speaker:Angela Bazigos
Time: 22nd February 2019 10:00 AM PDT | 01:00 PM EDT
Duration:180 Minutes
Model : AQ-9089

Fri
22
Feb 2019

Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts
Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts

Speaker:Angela Bazigos
Time: 11th June 2019 12:00 PM PDT | 03:00 PM EDT
Duration:90 Minutes
Model : FDAQ-9249

Tue
11
Jun 2019

Food Facility Inspection
Food Facility Inspection

Speaker:Angela Bazigos
Time: 18th December 2018 09:00 AM PDT | 12:00 PM EDT
Duration:180 Minutes
Model : FDAQ-9145

Tue
18
Dec 2018

How to Implement Good Clinical Practices for Successful FDA and International Regulatory Authority Inspections
How to Implement Good Clinical Practices for Successful FDA and International Regulatory Authority Inspections

Speaker:Angela Bazigos
Time: 6th March 2019 10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Model : FDAQ-9190

Wed
06
Mar 2019

How to Select & Manage Software Vendors in a Regulated Environment (incl. ICH E6)
How to Select & Manage Software Vendors in a Regulated Environment (incl. ICH E6)

Speaker:Angela Bazigos
Time: 1st February 2019 10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Model : FDAQ-9159

Fri
01
Feb 2019

Responding to FDA 483s and FDA Warning Letters - Can you afford not to be prepared?
Responding to FDA 483s and FDA Warning Letters - Can you afford not to be prepared?

Speaker:Angela Bazigos
Time: 25th January 2019 10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Model : FDAQ-9154

Fri
25
Jan 2019

Writing Effective SOPs for FDA Inspection & Regulatory Compliance
Writing Effective SOPs for FDA Inspection & Regulatory Compliance

Speaker:Angela Bazigos
Time: 11th December 2018 10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Model : FDAQ-9146

Tue
11
Dec 2018

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