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...

The goal for this course is to provide an understanding of cybersecurity leadership focused on people and not just technology and policy. It will give you an overview of frameworks to support your risk management activities. It is highly useful to any organizational executive, or leader seeking an understanding of building cybersecurity cultures and governance. The word cybersecurity is thrown around, used and abused to scare people into buyin...

Now Is Your Chance to Get Key Insights Directly from Agency Reform Leaders! The government reform initiative is well underway, and over the next month, all agencies will receive feedback on their high-level agency reform plan. Linda Springer, architect of the government-wide reorganization initiative, along with other government leaders will discuss reform plans and the opportunity for agencies to comprehensively redesign themselves so they ca...

YES, I am giving away the secrets to Passing the DCAA system audit with ease! Enjoy ALL DAY access on the date of purchase. You can replay again and again. This on demand webinar shows you, In QuickBooks, step-by-step, how to set up your system for compliance How to record your transactions to maintain compliance How to use your data to compute Indirect rates How to Allocate the indirect rates to Projects How to have a compliant Time keeping p...

This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017 and beyond. There are an enormous amount of issues and risks for covered entities and business associates these days. I will speak on speci...

This course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful market access. This includes: Design and TPP Pre-clinical testing and comparability Clinical testing Analytical studies Stability of biosimilar products Why you should attend: The regulation of Biosimilars is very complex and the approach used by various regions differs. Professi...