483s Web-based Seminars

Excel Spreadsheet Validation to Eliminate 483sGlobalCompliancePanel Overview: This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. Tuesday, June 5, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

What to do if you get a FDA 483 Warning Letter - Webinar By GlobalCompliancePanel Overview: Audits by the FDA are perhaps the most intimidating of all events at a regulated facility. Each year, the FDA conducts several thousand audits, approximately half of which lead to findings that result in Form 483s. Thursday, March 29, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Writing and Maintaining Quality Standard Operating Procedures SOPs to Guarantee FDA Compliance - Webinar By GlobalCompliancePane A cogent understanding and thorough knowledge of the regulations for SOPs is a necessity for product development and clinical testing organizations with the goal of agency approval, and product commercialization. Thursday, March 15, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Excel Spreadsheet Validation to Eliminate 483s - GlobalCompliancePanel This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. Tuesday, March 20, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Responding to FDA 483s - Webinar By GlobalCompliancePanel Many companies know that a written response is required when the company is issued a 483 by FDA, but they do not know or understand the importance of timing and the response wording. Wednesday, November 30, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Excel Spreadsheet Validation to Eliminate 483s - Webinar GlobalCompliancePanel This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. Tuesday, January 10, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Best Practices in Complaint Management - Webinar By GlobalCompliancePanel Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s. Wednesday, November 2, 2011 10: 00  more...

Excel Spreadsheet Validation to Eliminate 483 - Webinar By GlobalCompliancePanel This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for yo  more...

Excel Spreadsheet Validation to Eliminate 483s by gcp This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.  more...

FDAs New Process Validation Guidance - Webinar By GlobalCompliancePanel ... and current best practices, and expects to begin issuing 483s immediately. While the medical device industry has been subject to many of the requirements in the new guidance, most pharmaceutical firms and their suppliers have not implemented, and may not even fully understand, the advanced statistical, scientific, and management expectations now demanded by FDA with the release of this  more...

Excel Spreadsheets Step-By-Step Instructions for Compliance - Webinar By GlobalCompliancePanel ...adsheet applications that are GxP compliant. * Avoid 483s and warning letters. Critical data, such as laboratory information and other GxP data, is often recorded in spreadsheet applications and are subject to regulatory inspection. * Learn how to use Excela ™s built in 21 CFR Part 11 features. * Apply features required for GxP environments without programming macros. *  more...

Preparing for Pre-approval Inspections - Webinar By GlobalCompliancePanel ...ter the inspection such as preparation of the response to 483s will be discussed. Ample discussion time will be available at the halfway point in the webinar and again at the end of the webinar. Why you should attend: Pre-approval inspections provides a relatively narrow window of time during which the NDA/ BLA/ ANDA holder can demonstrate to the FDA that the quality systems at the site are  more...

Excel Spreadsheets - Develop and Validate to Eliminate 483s - Webinar By GlobalCompliancePanel Overview: Learn how to Use excel spreadsheet for GXP data and reduce validation cost and time. Configure Excel for audit trails, security features, and data entry verification. What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session will make you a better Excel  more...

Excel Spreadsheet Validation To Eliminate 483s - Webinar by GlobalCompliancePanel This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session will make  more...

Robust Process Validation for Medical Devices - Webinar by GlobalCompliancePanel ... is also one of the most common reasons companies receive 483s and warning letters. Conversely, successful validations not only satisfy compliance and regulatory requirements, they also provide for robust manufacturing processes satisfying the needs of many individual functions within your organization How do we get there? After we have a clear understanding of the regulatory intent of  more...

Best Practices in Complaint Management - Compliance Webinar by GlobalCompliancePanel ...es is among the most frequently cited observations on FDA-483s. This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action, as well as the ISO-specific implications. This session will discuss the best way to document customer feedback, what constitutes a  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...