Browsing Category Upcoming Events

Vendor Qualification Auditing for FDA Computer System Compliance| Jan. 18, 2012 | Poser

Note: FOI Services ran this event this summer at $449, $100 more than our price. Theirs also was a regular audioconference. This is a Webinar! This webinar by Dr. Richard Poser, First Quality, Inc., will explain and illustrate inspection and auditing of vendors who provide software used to support GXP manufacturing and testing, through audit [...]

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Category : Upcoming Events

Discover Risk-Based Approaches for Qualifying SharePoint Enterprise Deployments and Validating SharePoint Composite Applications for FDA-Regulated Environments | Jan. 19, 2012, 2-3 PM EST | O’Driscoll/Youmans/Woergaard

This Webinar by a team of seasoned GXP validation and SharePoint experts will introduce innovative best practice risk-based strategies, important processes and new exciting tools to help qualify enterprise Microsoft SharePoint deployments as well as validate mission critical applications such as clinical and investigator portals and document management in FDA regulated environments. The presentation — [...]

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Category : Upcoming Events

How to Avoid the Dreaded Refuse-to-File, Plus 2012 eCTD Mandate from Congress| Sept. 6, 2011, 2-3 PM EDT | Azevedo

One of our most praised presentations, this Webinar by renowned eCTD expert Antoinette Azevedo will provide an overview of best practices to enable a sponsor to prepare a compliant eCTD for regulatory authority review. So you can avoid a costly Refuse-to-File (RTF) by FDA. Note: All Expertbriefings.com Webinars are eligible for 1.0 CEU towards RACS [...]

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Category : Upcoming Events

Avoid FDA Enforcement: Configure and Validate Your Excel Spreadsheets to Prevent 483s| ARCHIVE | Nettleton

Avoid FDA Enforcement: Configure and Validate Your Excel Spreadsheets to Prevent 483s| ARCHIVE | Nettleton

Learn how to configure and validate Excel applications to avoid 483s. This interactive webinar presents step-by-step instructions followed by a hands-on Excel workshop where each participant follows along with a live demonstration. You will become a better Excel user, saving you time and costs, while advancing compliance. Archive Recording – Download Webinar the Same Day [...]

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Category : Upcoming Events

Getting Ready for Tougher FDA GMP Inspections – Feb. 15, 2012, 2-3:30 PM EST

Recent FDA audits have shown us that the past ways of doing things will no longer be acceptable. Increasingly reports from the field indicate that the Agency is using high-profile cases to drive compliance to smaller companies and suppliers. Recent events in regulated industries indicate a public’s growing dissatisfaction with what they view as a [...]

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Category : Upcoming Events

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