FDA’s 21 CFR Portion 11 was ordered within the late 1990s and execution victory over the pharmaceutical and other controlled businesses has been mixed.There are exceptionally particular confinements that emerge when utilizing ER/ES capability, such as the end of print capability to anticipate clients from making choices based on a paper record as contradicted to the electronic record.It moreover requires exceptionally particular distinguishing proof of clients that guarantees the individual marking the record is the same individual whose accreditations are being entered and confirmed by the system.Rules for changing passwords must be thoroughly followed to and the passwords must be kept secure.It is additionally basic that the framework indicate the precise meaning of the signature. It may be that the individual conducted the work, recorded the result, surveyed the result, or affirmed the result. A individual may basically be confirming to the truth that they checked on the work and the marks, and there was fitting isolation of obligations (i.e., the individual person recording the result is not the same as either the person reviewing or the person giving final approval).
A company must have particular arrangements and strategies in put that expressly state duties and give direction for executing and utilizing ER/ES capability. These must clarify the 21 CFR Portion 11 direction and give knowledge as to the way the company translates their duty for assembly it. As FDA proceeds to advance and alter due to the numerous components that impact the administrative environment, companies must be able to adjust. Modern innovations will proceed to rise that will alter the way companies do commerce. Whereas numerous of these are planning to streamline operations, diminishing time and assets, a few inadvertently result in included layers of oversight that hamper a computer framework approval program and require more time and assets, making the innovation ugly from a cost-benefit viewpoint.
Why should you attend ?
This webinar will assist you get it in detail the application of FDA’s 21 CFR Portion 11 direction on electronic records/electronic marks (ER/ES) for computer frameworks subject to FDA controls. This is often basic in arrange to create the fitting approval procedure and accomplish the meticulousness required to demonstrate that a framework does what it indicates to do. It moreover guarantees that a framework is kept up in a approved state all through its whole life cycle, from conception through retirement.
Areas covered during the session :
Who should attend
FDA’s 21 CFR Portion 11 was ordered within the late 1990s and execution victory over the pharmaceutical and other controlled businesses has been mixed.There are exceptionally particular confinements that emerge when utilizing ER/ES capability, such as the end of print capability to anticipate clients from making choices based on a paper record as contradicted to the electronic record.It moreover requires exceptionally particular distinguishing proof of clients that guarantees the individual marking the record is the same individual whose accreditations are being entered and confirmed by the system.Rules for changing passwords must be thoroughly followed to and the passwords must be kept secure.It is additionally basic that the framework indicate the precise meaning of the signature. It may be that the individual conducted the work, recorded the result, surveyed the result, or affirmed the result. A individual may basically be confirming to the truth that they checked on the work and the marks, and there was fitting isolation of obligations (i.e., the individual person recording the result is not the same as either the person reviewing or the person giving final approval).
A company must have particular arrangements and strategies in put that expressly state duties and give direction for executing and utilizing ER/ES capability. These must clarify the 21 CFR Portion 11 direction and give knowledge as to the way the company translates their duty for assembly it. As FDA proceeds to advance and alter due to the numerous components that impact the administrative environment, companies must be able to adjust. Modern innovations will proceed to rise that will alter the way companies do commerce. Whereas numerous of these are planning to streamline operations, diminishing time and assets, a few inadvertently result in included layers of oversight that hamper a computer framework approval program and require more time and assets, making the innovation ugly from a cost-benefit viewpoint.
Why should you attend ?
This webinar will assist you get it in detail the application of FDA’s 21 CFR Portion 11 direction on electronic records/electronic marks (ER/ES) for computer frameworks subject to FDA controls. This is often basic in arrange to create the fitting approval procedure and accomplish the meticulousness required to demonstrate that a framework does what it indicates to do. It moreover guarantees that a framework is kept up in a approved state all through its whole life cycle, from conception through retirement.
Areas covered during the session :
Who should attend
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.
During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA's electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.
Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI's Educational Fund as a project management instructor for non-profit organizations.
