Browsing Category Upcoming Events

Breaking Regulatory Update for Life Science Firms – UFA Requirements for eCTDs | June 19, 2013, 2-3:30 PM EDT | Azevedo

Is your life sciences firm ready for PDUFA and GDUFA mandates for electronic submissions? On July 9, President Obama signed the FDA Innovation and Safety Act (S3187) which reauthorized PDFUA and MDUFA, implemented the Generic Drug User Fee Act and the Biosimilar User Fee Act. All of these updated regulations have new, far-reaching consequences for [...]

Read More »

Category : Upcoming Events

FDA Hands Out CAPA 483s Like Candy – Avoid Them With a Closed Loop CAPA System | Aug. 14 2013, 2 PM EDT | Lincoln

Available Upon Request – Certificate of Attendance for All Attendees to Fulfill Training Requirements FDA hands out CAPA 483 violations like candy these days; CAPA violations actually were the #1 483 observation for 2010 and 2011, and will probably continue to be so in the future. This is because CAPA is so closely related to [...]

Read More »

Category : Upcoming Events

How to Survive Import Alerts and PREDICT – FDA’s New Import Screening Program | November 7, 2013, 2 PM EDT| England |

Feedback from our recent 2013 Webinar: “Thank you – the Webinar was extremely informative.” “Benjamin is a wonderful speaker and our team learned a lot today.” “Our staff really appreciated all of the great information the speaker related today.” The FDA’s PREDICT system has DRASTICALLY changed how FDA screens your drugs and devices that arrive [...]

Read More »

Category : Upcoming Events

The Most Deadly Serious FDA 483s and How You Can Avoid Them – November, 12, 2013 – Lincoln

This new webinar, set for November 12, 2013, at 2 PM EST, will detail some of the most recent and most serious FDA 483s. It will discuss the changing audit focus of the agency and how it affects how you do business. It will evaluate the chief areas of cGMP compliance audits, which are based [...]

Read More »

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 [...]

Read More »

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 [...]

Read More »

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 [...]

Read More »

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 [...]

Read More »

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 [...]

Read More »

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 [...]

Read More »

Category : Upcoming Events

Subscribe Now

Testimonial

"ExpertBriefings.com always selects excellent speakers – some of the best I have ever heard. Their messages are direct, clear, timely, and relevant."

Anon A. Mouse

Featured Partner