SyberWorks and Focus Compliance & Validation Services Announce How to Execute FDA Software Validation/Verification Webinar
SyberWorks, Inc., a leader in custom e-Learning Solutions and the Learning Management System (LMS) industry, announces a Webinar, How to FDA Execute Software Validation/Verification.
Waltham, MA, May 27, 2010 --(PR.com)-- Focus Compliance & Validation Services, will partner with SyberWorks to present the fundamentals of executing a software validation/verification plan. Professionals in the Life Sciences, Medical Device, Pharmaceuticals, Medical Manufacturing and other FDA regulated industries are encouraged to attend via Webinar on June 22nd.
How to Execute Software Validation/Verification
Date: Tuesday, June 22nd, 2010
Time: 11:00 a.m. to 12:00 p.m. PT / 2:00 p.m. to 3:00 p.m. ET
Visit https://www2.gotomeeting.com/register/486091818 to register for this Webinar.
Mark Walker, Vice President of Focus Compliance & Validation Services states, “Computer Systems are integral to the production and manufacturing of pharmaceuticals, medical devices, and bio-technology. Validation of these computer systems is not only important to achieving a quality product, but a regulatory requirement. During our webinar with SyberWorks, we will discuss what to consider in the development and execution of your Computer System Equipment and Software Validation / Verification. This will include the importance of the User Requirements to accurately map your intended use of the computer system. We look forward to this opportunity to work with SyberWorks.
Dave Boggs, CEO of SyberWorks says, “This webinar is the third in a series of webinars in which we are partnering with Focus Compliance & Validation Services to offer computer validation training for professionals associated with companies in the pharmaceutical, life sciences, biotechnology, medical device manufacturing or any other industry regulated by the FDA. This webinar is important because it reviews the nuts and bolts of FDA computer validation/verification plan.
How to Execute Software Validation/Verification
Date: Tuesday, June 22nd, 2010
Time: 11:00 a.m. to 12:00 p.m. PT / 2:00 p.m. to 3:00 p.m. ET
Visit https://www2.gotomeeting.com/register/486091818 to register for this Webinar.
About Focus Validation & Compliance Services, Inc.
Focus Compliance & Validation Services, Inc. is dedicated to providing regulatory compliance, validation, and process engineering services to the pharmaceutical, biotechnology, and medical device industry. Focus CVS is an innovative solutions provider to the U.S. Food & Drug Administration (FDA) regulated industry. Focus CVS delivers services and tools helping clients understand how to integrate good software-based engineering practices into their product-development methodologies for the purpose of FDA regulatory compliance.
Based on FDA and other regulatory agencies’ governance and guidance criteria and first-hand experience, Focus CVS defines applicable risk-based validation principles and best practices. These principles and best practices apply to processes that are used in, and the facilities and controls that are used for, Design, Manufacturing, Packaging, Labeling, Storage, Installation, Support, Servicing, and Retirement of regulated software-based products. Through integration of these principles, clients avoid and mitigate regulatory-agency scrutiny and comply with the Federal Food, Drug, and Cosmetic Act. For more information, visit www.focuscvs.com.
The SyberWorks Learning Management System/Learning Content Management System
SyberWorks Training Center (STC) is a Web-based Learning Management System (LMS)/Learning Content Management System (LCMS) that provides complete solutions for managing and tracking all types of training at your organization — from e-Learning courses to traditional classroom training and self-paced study programs. The STC includes extensive testing and assessment tools, reporting, management, communication and collaboration tools, and quality control capabilities — all in one integrated database application that is highly scalable to precisely meet your organization’s needs. The SyberWorks Training Center LMS/LCMS can be purchased as an enterprise license or hosted application.
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How to Execute Software Validation/Verification
Date: Tuesday, June 22nd, 2010
Time: 11:00 a.m. to 12:00 p.m. PT / 2:00 p.m. to 3:00 p.m. ET
Visit https://www2.gotomeeting.com/register/486091818 to register for this Webinar.
Mark Walker, Vice President of Focus Compliance & Validation Services states, “Computer Systems are integral to the production and manufacturing of pharmaceuticals, medical devices, and bio-technology. Validation of these computer systems is not only important to achieving a quality product, but a regulatory requirement. During our webinar with SyberWorks, we will discuss what to consider in the development and execution of your Computer System Equipment and Software Validation / Verification. This will include the importance of the User Requirements to accurately map your intended use of the computer system. We look forward to this opportunity to work with SyberWorks.
Dave Boggs, CEO of SyberWorks says, “This webinar is the third in a series of webinars in which we are partnering with Focus Compliance & Validation Services to offer computer validation training for professionals associated with companies in the pharmaceutical, life sciences, biotechnology, medical device manufacturing or any other industry regulated by the FDA. This webinar is important because it reviews the nuts and bolts of FDA computer validation/verification plan.
How to Execute Software Validation/Verification
Date: Tuesday, June 22nd, 2010
Time: 11:00 a.m. to 12:00 p.m. PT / 2:00 p.m. to 3:00 p.m. ET
Visit https://www2.gotomeeting.com/register/486091818 to register for this Webinar.
About Focus Validation & Compliance Services, Inc.
Focus Compliance & Validation Services, Inc. is dedicated to providing regulatory compliance, validation, and process engineering services to the pharmaceutical, biotechnology, and medical device industry. Focus CVS is an innovative solutions provider to the U.S. Food & Drug Administration (FDA) regulated industry. Focus CVS delivers services and tools helping clients understand how to integrate good software-based engineering practices into their product-development methodologies for the purpose of FDA regulatory compliance.
Based on FDA and other regulatory agencies’ governance and guidance criteria and first-hand experience, Focus CVS defines applicable risk-based validation principles and best practices. These principles and best practices apply to processes that are used in, and the facilities and controls that are used for, Design, Manufacturing, Packaging, Labeling, Storage, Installation, Support, Servicing, and Retirement of regulated software-based products. Through integration of these principles, clients avoid and mitigate regulatory-agency scrutiny and comply with the Federal Food, Drug, and Cosmetic Act. For more information, visit www.focuscvs.com.
The SyberWorks Learning Management System/Learning Content Management System
SyberWorks Training Center (STC) is a Web-based Learning Management System (LMS)/Learning Content Management System (LCMS) that provides complete solutions for managing and tracking all types of training at your organization — from e-Learning courses to traditional classroom training and self-paced study programs. The STC includes extensive testing and assessment tools, reporting, management, communication and collaboration tools, and quality control capabilities — all in one integrated database application that is highly scalable to precisely meet your organization’s needs. The SyberWorks Training Center LMS/LCMS can be purchased as an enterprise license or hosted application.
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Contact
SyberWorks, Inc.
Mary Kay Lofurno
781-891-1999
www.syberworks.com
411 Waverley Oaks Road
Building 3, Suite 319
Waltham, MA 02458
Mary Kay Lofurno
781-891-1999
www.syberworks.com
411 Waverley Oaks Road
Building 3, Suite 319
Waltham, MA 02458
Contact
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