Browsing Category Upcoming Events

Qualify Your Vendors – Designing and Implementing a cGMP-Compliant Vendor Program| Oct. 24, 2013, 2 PM EDT | Graham

This new Webinar will provide you with exact details of what you need to do to design a fully cGMP compliant vendor program for your pharmaceutical or medical device supply chain. You will learn how to implement it throughout your company, how to deal with all documentation issues, and how to communicate efficiently with your [...]

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Category : Upcoming Events

How to Bulletproof Your 510(k) Submission: Best Practices for Preparation, Submission and Clearance | Nov. 7, 2013, 2 PM EDT | Lim

This Webinar will tell you precisely how to prepare and submit a traditional premarket notification 510(k) for successful FDA clearance. The premarket notification 510(k) is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs). If FDA changes its ruling on certain types of medical devices, such as tanning beds which [...]

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Category : Upcoming Events

Update on Tanning Beds and the FDA 510(k) Submission Process, Contents and Format | Sept 10, 2013 | Lim

Exclusive cGMP, FDA and 510(k) Compliance News FDA in May 2013 came out with a proposed order that if it is finalized, is going to reclassify tanning beds and related sunlamp products as class II medical devices, and they will require a label that will warn people under 18 to not use such products. This [...]

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Category : Upcoming Events

The Essentials of Complaint Handling and Post Market Management – How to Comply with Global Regulatory Requirements | Jan. 28, 2014, 2-3:30 PM EDT | Rodriguez

Complaint Handling and Post Market Management Webinar Summary Available Upon Request – Certificate of Attendance for All Attendees to Fulfill Training Requirements FDA investigators consider how a medical device company handles complaints to be an important indicator of a manufacturer’s overall state of control of their Quality System— if the complaint and MDR systems are [...]

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Category : Upcoming Events

How to Effectively Source OTC, Generic Formulations and APIs from Indian Pharmaceutical Manufacturers | June 13, 2013, 10:30-12:00 PM EST | Balani

In this upcoming webinar on May 14, Ram Balani, CEO-Founder at FDASmart.com will get under the hood and help you understand Indian pharma to your sourcing advantage with the following: Make you understand where India fits in today’s global pharmaceutical scenario Bring you up to speed with India’s pharmaceutical history and evolution, the regulatory mandates [...]

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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 [...]

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Category : Upcoming Events

FDA Recall Chief Update – How to Design a Bulletproof Product Recall Strategy | Sept. 19, 2013, 2 PM EDT | Hoffman

Available Upon Request – Certificate of Attendance for All Attendees to Fulfill Training Requirements Recall compliance is critical to the continued survival of all device manufacturers. FDA  is continuing its efforts to issue numerous Warning Letters and serious enforcement actions, including criminal and civil penalties levied on companies that fail to properly report events and [...]

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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 [...]

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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 [...]

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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 [...]

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Category : Upcoming Events

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