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Validity : 20th Apr'24 to 30th Apr'24
Mz.Angela Bazigos
Area Of Expertise : Quality Assurance,21 CFR 11,Computer Systems Validation, Project Management
30 Years Of Experience
Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. 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.
11 results Found
Recorded Webinar
European Data Protection Regulation – 2018 Implementation
Whenever you open a bank account, join a social networking website or book a flight online, you hand over vital personal information such as your name, address, and credit card number. Personal data collected by life sciences companies from subjects participating in ...
- Basic & Intermediate
- 90 Mins
On-Demand Webinar
Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts
With the emerging utilization of computerized technologies in the late 1980s and early 1990s, the pharmaceutical industry asked the FDA for guidance regarding compliance of the resulting electronic records. After several years of development and industry comments, 21 ...
- Basic & Intermediate & Advanced
- 90 Mins
On-Demand Webinar
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, re ...
- Intermediate
- 90 Mins
On-Demand Webinar
Responding to FDA 483s and FDA Warning Letters - Best Practices
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.
- Basic & Intermediate & Advanced
- 90 Mins
On-Demand Webinar
FDA’s 21 CFR Part 11 Add-on Inspections
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. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the or ...
- Basic & Intermediate
- 90 Mins
On-Demand Webinar
21 CFR 11 Compliance for Excel Spreadsheets
In Dec. 2010, the FDA has stepped up enforcement for 21 CFR 11 compliance with spreadsheets being considered as low hanging fruit for FDA inspectional findings.This Excel spreadsheet compliance training will outline the FDA requirements for Excel spreadsheets used in ...
- Basic & Intermediate
- 90 Mins
Recorded Webinar
FDA Enforcement of 21 CFR 11 Compliance
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate data integrity, security and availability o ...
- Basic
- 90 Mins
Recorded Webinar
21 CFR Part 11: Basic Concepts for FDA Regulated Companies
This presentation provides an overview and historical perspective of the Part 11 regulation, the general requirements,electronic records requirements, and electronic signatures requirements Critical, regulated training provides compliance, improves processe ...
- Basic
- 60 Mins
On-Demand Webinar
Identification, Correction and Prevention of Human Errors in GMP Manufacturing and Laboratory
Analysis of investigation reports reveal that human error is one of the top root causes for deviations, discrepancies and quality incidents in pharmaceutical manufacturing. And when you examine the CAPA's that are developed from these, retraining and rewrite of SOP i ...
- 90 Mins
On-Demand Webinar
Data Integrity – Big, Hard and Here to Stay!
The recent influx of concerns over data manipulation and other data integrity questions in India, China and elsewhere has pushed the US Food and Drug Administration (FDA) to put out new draft guidance to help the pharmaceutical industry ensure data is consistent and ...
- 180 Mins