Computer System Validation Web-based Seminars

GxP Computer System Validation The investigators Point of View - Webinar By GlobalCompliancePanel Overview: The webinar explains what is needed to prepare for an audit or regulatory inspection. It addresses SOPs for the GxP and IT infrastructure, hardware and software qualification, computer system validation, and change control for revalidation. This event is applicable to regulated companies and software vendors. Tuesday, July 10, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Efficient Computer System Validation - GlobalCompliancePanel Overview: This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. The 10-step risk-based approach to COTS software validation minimized documentation and ensures efficient implementation of new and upgraded computer systems. This experience will prepare you to perform a validation project. Tuesday, May 15, 2012 10:  more...

Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 - Webinar By GlobalCompliancePanel In July 2010, the FDA announced to conduct a series of inspections related to 21 CFR Part 11. In meantime the program is still on-going. FDA made it very clear that Part 11 is in effect and will be enforced according to original Part 11 and the guidance from 2003. Thursday, April 26, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Computer System Validation Step-by-Step - Webinar GlobalCompliancePanel This webinar will give a good understanding of FDA requirements for computer system validation and provide steps for cost-effective implementation. Thursday, January 26, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Efficient Computer System Validation - 10 Easy Steps - GlobalCompliancePanel This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. Wednesday, February 1, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Efficient Computer System Validation - 10 Easy Steps - Webinar GlobalCompliancePanel This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. Tuesday, November 15, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Efficient Computer System Validation - 10 Easy Steps - Webinar By GlobalCompliancePanel ...ications, risk management, and testing. * Document a computer system validation project using easy to understand fill-in-the-blank templates. * Based on: "Risk-Based Software Validation a Ten Easy Steps" (Davis Horwood International and PDA - www. pda. org, 2006). * Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce  more...

Utilizing Good Requirements as a Foundation for the Effective Validation of PDMA-related Computerized Systems - Webinar By Globa Overview: Computerized systems can be a boon to the Sales and Marketing group of an organization that falls within FDA regulatory authority. By automating, tracking, and reporting on thousands of sample product transactions, such systems can provide a powerful mechanism for compliance to the requirements of the Prescription Drug Marketing Act (PDMA), while accomplishing this with a manageable  more...

Computer System Validation Step-by-Step - Webinar by GlobalCompliancePanel Learn computer system validation essentials and eight fundamental steps of implementation for cost saving. Get complementary SOPs and checklists for easy implementation. Understand the structure of validation plan, documentation of ongoing performance, structure of validation report.  more...

Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 - Prepare Yourself for the upcoming FDA Part On July 8, 2010, the FDA announced to soon conduct a series of inspections related to 21 CFR Part 11. FDA made it very clear that the focus of the inspections will on most critical issues the industry had with Part 11 in the past. The best way to find out what the issues are is to look at recent FDA 483 form inspectional observations and warning letters related to computer system validation and  more...

Ten-Step Process for COTS Computer System Validation - Reduce Time and Cost ...s a new webinar on the topic of Ten-Step Process for COTS Computer System Validation - Reduce Time and Cost. Webinar will be on April 6, 2010. Webinar will be presented by David Nettleton. This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. The 10-step risk-based approach to COTS software validation minimized  more...

21 CFR Part 11 - Compliance for Electronic Records and Signatures GlobalCompliancePanel brings a new webinar for the medical devices industry professionals. Webinar will be on March 24, 2010. Webinar will be presented by David Nettleton. Mr. Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation - Ten easy Steps" that relates to the development, purchase,  more...

Excel Spreadsheet Validation To Eliminate 483s GlobalCompliancePanel brings a new webinar on the topic of Excel Spreadsheet Validation To Eliminate 483s. Webinar will be on March 10, 2010. Webinar will be presented by David Nettleton. Mr. Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation - Ten easy Steps" that relates to the development,  more...