PR Log - Sep 20, 2012 - Why to attend
Federal laws and regulations mandate to put controls and measures on a company network to ensure security and data integrity. Examples are 21 CFR Part 11, Sarbanes-Oxley Act, and HIPAA. With this legislation IT infrastructure and network qualification and compliance become a much more recognizable issue at higher levels of management. However currently there is no official guideline and the situation is similar to what happened with computer validation in early 90's and with early Part 11 issues. Until there will be an industry wide accepted approach companies either waste valuable resources because doing too much or take a risk to fail inspections because not doing enough or doing it wrong. With FDA's renewed focus on computer validation and IT systems, industry is looking for advice on how to comply for networks and infrastructure. This seminar will have the answers. During the seminar, the speaker will go through the requirements and give practical recommendations for cost-effective qualification. After the seminar, an extensive list of reference material like SOPs, templates and examples will help trouble-free implementation.
Areas Covered in the Seminar:
* Laws, regulations and guidelines- 21 CFR Part 11, HIPAA, Sarbanes-Oxley
* FDA inspection/enforcement practices: examples for Warning Letters/483s
* The FDA Industry Guide: Cybersecurity for Networks
* The GAMP/ISPE Good Practices Guides and the IVT NIQ Standard
* Principles and advantages of network infrastructure qualification
* Compliance concepts for infrastructure vs. networked systems
* Approaches and examples for risk assessment
* Configuration management and change control: the most important steps
* Qualification of PC clients, servers, data centers
* What and how much to test with the risk based cost/benefits in mind
* Handling security patches
* Dealing with existing/legacy infrastructure
* Considerations for network retirement
* Qualification of virtual networks and CLOUD computing
* How to maintain the validate state during on-going use
* Documentation requirements
* Going through a life inspection
And for easy and instant implementation:
download 10+ documents from special seminar website.
They include
* PowerPoint Presentation
* Script
* Example: Network Infrastructure Qualification Plan
* SOP: Risk Based Qualification of Network Infrastructure
* SOP: Qualification of PC Clients
* SOP: Qualification of Data Centers
* SOP: Qualification of Servers
* SOP: Handling Security Patches
* SOP: Testing File Integrity of E-Mail Attachments
* SOP: Using the Internet in Regulated Environments
* SOP: Qualification of Virtual Networks
* SOP: Change Control for Networks and Systems - Planned Changes
* SOP: Change Control for Networks and Systems - Unplanned Changes
* Gap Analysis/Worksheet: Network Qualification and System Validation
* IVT Standard: Network Infrastructure Qualification
* Example: Testing Authorized System Access
* Examples: Network Infrastructure and System Identification
Date: January 10, 2013
Time: 11.00 - 12.00 a.m. ET
Location: Online, worldwide
Who should attend
* IT managers and staff
* Everybody responsible for FDA compliance of computer systems
* Managers from purchasing, documentation and operations
* All users of computer systems used in regulated environments
* QA managers and personnel
* GLP/GMP/GCP auditors
* Consultants
* Teachers
Weblink: http://www.labcompliance.com/seminars/audio/305/default.aspx
Category: Pharmaceutical, Medical device, GMP, API Manufactuer, FDA, Training
Presenter: Dr. Ludwig Huber
Ludwig Huber, Ph.D., is Director for global FDA compliance at Labcompliance. He is the author and editor of www.labcompliance.com, the global on-line resource for validation and (laboratory) compliance. Dr. Huber has been presenting more than 200 web, video and audio seminars. He has been selected as IVT's "Presenter of Year" out of 175 presenters. He is also the author of more than 100 papers about FDA and international compliance (including the bestselling books “Validation of Computerized Analytical Systems” and “Validation and Qualification in Analytical Laboratories)”. Currently, Dr. Huber is on the Scientific Advisory board of IVT’s GxP and Validation Journals, and he has given multiple presentations and workshops mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included workshops and presentations for the US FDA, ISPE, PDA, PDA, PIC/S and several national health agencies including China SFDA
Weblink: http://www.ludwig-huber.com
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Federal laws and regulations mandate to put controls and measures on a company network to ensure security and data integrity. Examples are 21 CFR Part 11, Sarbanes-Oxley Act, and HIPAA. With this legislation IT infrastructure and network qualification and compliance become a much more recognizable issue at higher levels of management. However currently there is no official guideline and the situation is similar to what happened with computer validation in early 90's and with early Part 11 issues. Until there will be an industry wide accepted approach companies either waste valuable resources because doing too much or take a risk to fail inspections because not doing enough or doing it wrong. With FDA's renewed focus on computer validation and IT systems, industry is looking for advice on how to comply for networks and infrastructure. This seminar will have the answers. During the seminar, the speaker will go through the requirements and give practical recommendations for cost-effective qualification. After the seminar, an extensive list of reference material like SOPs, templates and examples will help trouble-free implementation.
Areas Covered in the Seminar:
* Laws, regulations and guidelines- 21 CFR Part 11, HIPAA, Sarbanes-Oxley
* FDA inspection/enforcement practices: examples for Warning Letters/483s
* The FDA Industry Guide: Cybersecurity for Networks
* The GAMP/ISPE Good Practices Guides and the IVT NIQ Standard
* Principles and advantages of network infrastructure qualification
* Compliance concepts for infrastructure vs. networked systems
* Approaches and examples for risk assessment
* Configuration management and change control: the most important steps
* Qualification of PC clients, servers, data centers
* What and how much to test with the risk based cost/benefits in mind
* Handling security patches
* Dealing with existing/legacy infrastructure
* Considerations for network retirement
* Qualification of virtual networks and CLOUD computing
* How to maintain the validate state during on-going use
* Documentation requirements
* Going through a life inspection
And for easy and instant implementation:
download 10+ documents from special seminar website.
They include
* PowerPoint Presentation
* Script
* Example: Network Infrastructure Qualification Plan
* SOP: Risk Based Qualification of Network Infrastructure
* SOP: Qualification of PC Clients
* SOP: Qualification of Data Centers
* SOP: Qualification of Servers
* SOP: Handling Security Patches
* SOP: Testing File Integrity of E-Mail Attachments
* SOP: Using the Internet in Regulated Environments
* SOP: Qualification of Virtual Networks
* SOP: Change Control for Networks and Systems - Planned Changes
* SOP: Change Control for Networks and Systems - Unplanned Changes
* Gap Analysis/Worksheet: Network Qualification and System Validation
* IVT Standard: Network Infrastructure Qualification
* Example: Testing Authorized System Access
* Examples: Network Infrastructure and System Identification
Date: January 10, 2013
Time: 11.00 - 12.00 a.m. ET
Location: Online, worldwide
Who should attend
* IT managers and staff
* Everybody responsible for FDA compliance of computer systems
* Managers from purchasing, documentation and operations
* All users of computer systems used in regulated environments
* QA managers and personnel
* GLP/GMP/GCP auditors
* Consultants
* Teachers
Weblink: http://www.labcompliance.com/seminars/audio/305/default.aspx
Category: Pharmaceutical, Medical device, GMP, API Manufactuer, FDA, Training
Presenter: Dr. Ludwig Huber
Ludwig Huber, Ph.D., is Director for global FDA compliance at Labcompliance. He is the author and editor of www.labcompliance.com, the global on-line resource for validation and (laboratory) compliance. Dr. Huber has been presenting more than 200 web, video and audio seminars. He has been selected as IVT's "Presenter of Year" out of 175 presenters. He is also the author of more than 100 papers about FDA and international compliance (including the bestselling books “Validation of Computerized Analytical Systems” and “Validation and Qualification in Analytical Laboratories)”. Currently, Dr. Huber is on the Scientific Advisory board of IVT’s GxP and Validation Journals, and he has given multiple presentations and workshops mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included workshops and presentations for the US FDA, ISPE, PDA, PDA, PIC/S and several national health agencies including China SFDA
Weblink: http://www.ludwig-huber.com
Read Full Story - Web Seminar: FDA Compliant IT Infrastructure and Network Qualification | More news from this source
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