Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. The experience combines Quality Assurance, Regulatory Compliance, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, and Turnarounds. Past employers/clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers, Public Health Service. Positions include: - Chief Compliance Officer, http://morflearning.com/angelabazigos/. - QA Director, Director of MIS. Co-authored & prototyped 21 CFR 11 guidance with FDA. - Co-authored Computerized Systems in Clinical Research w/ FDA http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashx. - The patent on speeding up software compliance https://www.google.com/patents/US8266578. - Recently quoted in the Wall Street Journal for using training to bring regulatory compliance to the Boardroom http://blogs.wsj.com/riskandcompliance/2015/07/24/using- training-to-bring-compliance-to-boardrooms/ - Comments / collaborates with the FDA on new guidance documents. - Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for Life Sciences: http://www.stanfordwhoswho.com /Angela.Bazigos.7144112.html#overview.
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 with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by an explanation on how to get from..
Computerized systems are used throughout the life sciences industry to support various regulated activities, which in turn generate many types of electronic records. These electronic records must be maintained according to regulatory requirements contained within FDA’s 21 CFR Part 11 for US jurisdictions and Eudralex Volume 4 Annex 11 for EU jurisdictions.One of the requirements for such compliance is the g..
Analysis of investigation reports reveals 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 is top the list. Yet on further re-examination, you find that these problems keep resurfacing again and again. Put in another way, the CAPA's a..
FDA Regulations Associated with the Detection, Correction and Prevention of Human Errors in GMP Manufacturing and Laboratory Processes
We are often quick to ascribe fault to people rather than our systems, facilities, and operations. However, in this class, we will learn how to tell if you are too quick to ascribe guilt to people rather than probe deeper. We will focus on improved techniques to get to the real cause of the problem. With this information, you will be able to develop meaningful CAPAs that have a chance to remedy these proble..
The evolution of computerized technologies has been both amazing and challenging. Each new wave of technological evolution has been accompanied by a series of compliance challenges, and subsequent strategies to comply with applicable regulatory requirements. Cloud computing is a current example of this evolution. This presentation will provide a discussion of Cloud concepts, terminology, definitions, ..
Disasters and disruptions of business rarely occur, but if they do they can be costly and dangerous. In R&D, Manufacturing & Retail areas of a food company, there can be dangerous contaminants and other disasters and important data and business processes that could be lost. Every company has a responsibility to their stakeholders (clients, shareholders, employees) and to regulators, to take steps to..