Practice Makes Perfect: A Two-Part Webinar that Combines Hands-On Exercises, Discussions, and Instruction. The Harmonized Commodity Description and Coding System (“Harmonized System”) is used by more than 150 countries, including the United States, for the classification of products that are traded around the world. For importers, understanding how to classify goods under the Harmonized System is critical for determining the duty r...

We would like to welcome you to the 3rd Annual Pre-Filled Syringes Summit on September 28th – 29th, 2017 in Barcelona, Spain. This event provides the appropriate platform for industry leaders to discuss best practices as well as new developments in Pre-Filled Syringes (PFS). The Summit will provide a broad overview of market trends and device needs; technologies and innovations; delivery aspects of parenteral drugs; as well as regulatory...

Take a Coffee Break with AccessData®! Your days are busy. Finding the time to keep your skills up-to-date is a challenge. That's why we're offering a series of 30-minute webinars—quick hits that will give you great information about a variety of topics. These on-demand webinars are recorded in case you were not able to attend. These webinars will be best suited for the end users. If you are not an end user, please feel free to forwar...

(DSB) Designing Secure Buildings: Integrating Security Technologies – This 3-day workshop is designed to familiarize students with twenty-one design principles used in preventing and detecting criminal activity and reducing the effects of acts of terrorism on the safety of personnel and damage to facilities and critical infrastructure. Specific modules include; Terrorism Ideologies, Security Basics, Philosophies and Design Strategies, Bl...

It’s Not New, and It’s Still Not Easy: Mastering the ITAR and EAR Definition Accurately applying the definition “specially designed” is no longer a new challenge, but it still remains a critical element in correctly determining how the US Munitions List (USML) and Commerce Control List (CCL) control the items you export. This webinar series will use hands-on exercises and questions and answers to enhance your skill and...

ITAR Part 129 is broad, complex, and often misunderstood... Are you an arms broker without knowing it? Do you know when referring customers to outside vendors, working with sales agents, and other seemingly innocent activities implicate Part 129? Do you know how to comply with Part 129 registration, prior approval, annual reporting, and recordkeeping requirements? This webinar will cover the fundamentals of Part 129 compliance for manufacturer...

There is a wealth of information on “WHY” companies must build a compliance program, but a lack of practical instruction on “HOW TO” build a solid compliance program to effectively prevent compliance lapses in today’s digital world... This webinar will present an updated paradigm and framework for modern export control compliance programs that are risk-appropriate, business integrated, and in tune with today...

EMA has a 20-year track record of ensuring efficacy and safety of human and veterinary medicines across Europe, and promoting research and innovation in the development of medicines. In its first two decades, the Agency recommended the authorization of a total of 975 human and 188 veterinary medicines. EMA's success is based on cooperation within the European medicines regulatory network - a unique partnership between the European Commission,...

If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affair...

The final version of ISO 13485:2016 is now available and companies should be planning their implementation. There are significant changes from the earlier version; they will require major modifications to the Quality Management System (QMS). The new version has better alignment with FDA's QSR, but there are still major differences that create issues for effective QMS implementation. This workshop covers the differences from the 2003 version to...