Angela Bazigos
Angela Bazigos
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,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 Patent on speeding up software compliance.
Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom 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.
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3-Hour Virtual Seminar on Project Management for Computer Systems Validation
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... -
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
Virtually every FDA inspection includes a review of SOPs and adverse agency findings are often the result of SOP administration issues. Standard Operating Procedures (SOPs) are required by law for companies that are regulated by the Code of Federal... -
3-Hour Virtual Seminar on Off Label Promotion for Drugs and Medical Devices
FDA and industry have struggled for the past 10 years, with the question of how FDA can reconcile its mission to protect public health by ensuring that medical products distributed in the United States are safe and effective for... -
3-Hour Virtual Seminar on Excel Spreadsheet Validation for FDA 21 CFR Part 11
Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used... -
If it is not written down, it did not happen – Complying with FDA’s Good Documentation Practices
GDP is commonly abbreviation for Good Documentation Practice. It has been recommended to be abbreviated as GDocP to distinguish from “good distribution practice” also abbreviated GDP. Now, GDP is a term in the regulated industry to characterize standards by... -
FDA Guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices
Description: This course will be immensely helpful to Supplier Auditors and Supplier quality engineers who would like a deeper understanding of the fast changing medical device regulations that are pertinent to bringing in a new supplier and maintaining them... -
Computerized System Validation: Basic Concepts
Description: Test Areas to be Covered: Test Who will Benefit: Test -
Project Management for Computer Systems Validation
Description: This webinar will discuss the Part 11 requirements and practical techniques for evaluation of the current compliance status of a given organization. You will hear about validation requirements, system security protocols, rules for building computer networks, adding new... -
21 CFR 11 Compliance for Excel Spreadsheets
Description: 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. Spreadsheet Applications such as MS Excel are frequently used in 21 CFR... -
Drug Development & Discovery by FDA Standards
Description: The Drug Discovery and Development (but also the biologics and medical device) process is a very complex process with every participant focusing on their particular piece of discovery or development. You can spend a lifetime in your part... -
FDA’s 21 CFR Part 11 Add-on Inspections
Description: In December 2010 the FDA began a project to better understand the industry’s adherence (or lack thereof) to 21 CFR Part 11. This involves the add on’ surveillance inspections of the sponsors’ computer systems during the course of... -
Regulatory Issues in Pharmacogenomics
Description: This presentation will begin by giving an overview of Pharmacogenomics and how it is used in drug development. It will then identify the agencies that regulate Pharmacogenomics data, and explain what the regulations are. It will then go... -
Good Clinical Practices
Description: Adherence to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) is universally recognized as a critical requirement to the conduct of research involving human subjects. Many countries have adopted GCP principles as laws... -
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
Description: 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. It will begin... -
21 CFR 11 Compliance for Excel Spreadsheets
Description: 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. Spreadsheet Applications such as MS Excel are frequently used in 21 CFR... -
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
Description: 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. It will begin... -
21 CFR 11 Compliance for Excel Spreadsheets
Description: 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. Spreadsheet Applications such as MS Excel are frequently used in 21 CFR... -
How to select Software for a Regulated Environment
Description: 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... -
FDA’s 21 CFR Part 11 Add-on Inspections
Description: In December 2010 the FDA began a project to better understand the industry’s adherence (or lack thereof) to 21 CFR Part 11. This involves the add on’ surveillance inspections of the sponsors’ computer systems during the course of... -
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
Description: 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. It will begin... -
21 CFR 11 Compliance for Excel Spreadsheets
Description: 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. Spreadsheet Applications such as MS Excel are frequently used in 21 CFR... -
Project Management for Computer Systems Validation
Description: This webinar will discuss the Part 11 requirements and practical techniques for evaluation of the current compliance status of a given organization. You will hear about validation requirements, system security protocols, rules for building computer networks, adding new... -
FDA Guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices
Description: This course will be immensely helpful to Supplier Auditors and Supplier quality engineers who would like a deeper understanding of the fast changing medical device regulations that are pertinent to bringing in a new supplier and maintaining them... -
Computerized System Validation: Basic Concepts
Description: Test Areas to be Covered: Test Who will Benefit: Test -
21 CFR 11 Compliance for Excel Spreadsheets
Description: 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. Spreadsheet Applications such as MS Excel are frequently used in 21 CFR... -
Sale!
Drug Development & Discovery by FDA Standards
Description: The Drug Discovery and Development (but also the biologics and medical device) process is a very complex process with every participant focusing on their particular piece of discovery or development. You can spend a lifetime in your part... -
FDA’s 21 CFR Part 11 Add-on Inspections
Description: In December 2010 the FDA began a project to better understand the industry’s adherence (or lack thereof) to 21 CFR Part 11. This involves the add on’ surveillance inspections of the sponsors’ computer systems during the course of... -
Sale!
Regulatory Issues in Pharmacogenomics
Description: This presentation will begin by giving an overview of Pharmacogenomics and how it is used in drug development. It will then identify the agencies that regulate Pharmacogenomics data, and explain what the regulations are. It will then go... -
Good Clinical Practices
Description: Adherence to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) is universally recognized as a critical requirement to the conduct of research involving human subjects. Many countries have adopted GCP principles as laws... -
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
Description: 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. It will begin... -
21 CFR 11 Compliance for Excel Spreadsheets
Description: 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. Spreadsheet Applications such as MS Excel are frequently used in 21 CFR... -
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
Description: 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. It will begin... -
21 CFR 11 Compliance for Excel Spreadsheets
Description: 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. Spreadsheet Applications such as MS Excel are frequently used in 21 CFR... -
How to select Software for a Regulated Environment
Description: 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... -
FDA’s 21 CFR Part 11 Add-on Inspections
Description: In December 2010 the FDA began a project to better understand the industry’s adherence (or lack thereof) to 21 CFR Part 11. This involves the add on’ surveillance inspections of the sponsors’ computer systems during the course of... -
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
Description: 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. It will begin... -
21 CFR 11 Compliance for Excel Spreadsheets
Description: 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. Spreadsheet Applications such as MS Excel are frequently used in 21 CFR... -
21 CFR 11 Compliance for Excel Spreadsheets
Description : 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. Spreadsheet Applications such as MS Excel are frequently used in 21... -
21 CFR 11 Compliance for Excel Spreadsheets
Description : 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. Spreadsheet Applications such as MS Excel are frequently used in 21...
