OnlineCompliancePanel
Angela Bazigos
CEO of Touchstone Technologies Silicon Valley, Inc,
Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Compliance”. She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance.

Ms. Bazigos is the president of PRCSQA (Pacific Regional Chapter of the Society of Quality Assurance) a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to Pharma / Biotech / Medical Device companies as well as investment groups on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry

More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and on the Stanford Who’s Who Registry for contributions to the Life Science industry.
Subscribe to
Newsletter
Subscribe today to get industry updates and exclusive deals on offer.
Upcoming Training
This webinar will present the results of the MDUFA III and will describe how your company will need to do business with the FDA in the next five years. It will describe how the FDA will use the User Fees to make changes within the agency and the expectations that the FDA will have of your company, as a result of those changes, to help your company prepare both strategically and tactically for regulatory interactions in the next five years.
Live Session  Wednesday, June 25, 2014 10:00 AM PDT | 01:00 PM EDT,  Duration:90

This webinar introduces FDA’s guidance "Design Considerations for Pivotal Clinical Investigations in Medical Devices" that was published in late 2013. It discusses the regulatory considerations for clinical study design, and delves into the issues of bias and variance that may impact the quality of the data obtained in the study, as well as the interpretation of the data.
Live Session  Wednesday, July 2, 2014 10:00 AM PDT | 01:00 PM EDT,  Duration:90
Recorded Training
This webinar introduces FDA’s guidance "Design Considerations for Pivotal Clinical Investigations in Medical Devices" that was published in late 2013. It discusses the regulatory considerations for clinical study design, and delves into the issues of bias and variance that may impact the quality of the data obtained in the study, as well as the interpretation of the data. Following that, it discusses way that are available to a medical device sponsor, for eliminating bias and variance, both in terms of the study design and the requirements for the personnel that will design and run the studies. Finally, it touches on the study protocol and statistical plan and discusses ways to use those to ensure the success of the study.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

FDA has stepped up enforcement for 21 CFR 11 compliance with spreadsheets being considered as low hanging fruit for FDA inspectional findings.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

Virtually every FDA inspection includes a review of SOPs and adverse agency findings are often the result of SOP administration issues. 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 Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

Cloud computing has become perhaps the hottest compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantees that management will expect that compliance strategies will be developed that will support decisions to utilize cloud environments to perform regulated activities.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation. Understanding the requirements of Part 11 is critical to compliance with the regulation. Knowledge of regulatory requirements is an exercise in efficiency…both efficiency in project management, and avoidance of non-compliance penalties.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

Software is widely used in our industry and selection of new software or upgrade of existing software is one of the activities that crop up every year in an IT department’s task list. Our industry, has the added challenge of being subject to both regulations that add another degree of complexity to this already complex task.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

Regulatory Inspections are performed by various agencies to assure that anyone involved in the lifecycle of a pharmaceutical / biotech / medical device product, abides by the laws and regulations. This affects the entire supply chain.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.