Browsing Category Upcoming Events

FDA 483 Aftermath – How Should You Respond? | March 20, 2014, 2 PM EST | Dennis Moore

FDA is more vigilant and aggressive than ever before with its cGMP  inspection procedures. In the words of Commissioner Margaret Hamburg, FDA is quick, visible and vigilant. In this comprehensive Webinar by Dennis Moore, Chief Technical Expert and Managing Partner of Auk Technical Services LTD, you will learn how you should respond in the aftermath [...]

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Category : Upcoming Events

Prepare Yourself for 21 CFR Part 11 Inspections| July 18, 2013, 2-3 PM ET | Avellanet

FDA announced in 2012 that it will soon begin to conduct 21 CFR Part 11 inspections. Are you ready? In this Webinar, John Avellanet will detail how to prepare yourself for coming Part 11 audits by FDA, as well as how to comply with the revised EMA Annex 11. What You Will Learn: Status of [...]

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Category : Upcoming Events

Audit Your Lab Like an FDA Auditor: A Roadmap to Lab Compliance – From cGMPs to Inspection Readiness| April 24, 2014, 2 PM EDT | Medina

Audit Your Lab Like an FDA Auditor: A Roadmap to Lab Compliance – From cGMPs to Inspection Readiness| April 24, 2014, 2 PM EDT | Medina

  This one-of a kind, comprehensive workshop will guide participants through understanding the substantive requirements for any lab, domestic or foreign, interested in validating, testing, and releasing drug product in support of regulatory submissions, as clinical trial material, or for commercial US distribution. Carmen Medina was an FDA investigator based out of the Miami field [...]

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Category : Upcoming Events

How to Mitigate Raw Materials Risk and Stay GMP Compliant | Feb. 27, 2013, 2-3 PM EDT

Many FDA observations during GMP audits include issues that pertain to raw materials. Most warning letters sent by FDA to GMP plants will cite raw material management problems. FDA auditors pay a close eye to the ways that your raw materials are sourced, controlled, handled, accounted for and utilized at each facility. Raw material management [...]

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Category : Upcoming Events

What You Must Know About FDA’s New Biosimilars Guidance | Siegel | Sept. 27, 2012, 2 PM EDT

On February 9, FDA released its first guidance on potential approval pathways for BLAed biosimilar drug products. A variety of positive options for strategic and tactical approaches were detailed. This included the use of both US- and ex-US- innovator data to partially support these products and the possibility of extrapolating extant data to allow consideration [...]

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Category : Upcoming Events

Compliant Safety Reporting in Clinical Trials – Are You Following FDA Rules? | Oct. 3, 2012, 2-3 PM EST

This Safety Reporting in Clinical Trials webinar on March 29 will review FDA’s recent major revisions to IND safety reporting requirements. It will explain FDA’s current expectations of sponsors, investigators, IRBs, and other personnel responsible for reporting safety related information while conducting clinical trials with a new investigational product or a generic drug. If your [...]

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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

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