- Time:
- 1:30pm-9:30pm
- Description:
- Course Description:
Federal regulation of the advertising and promotion of pharmaceuticals and medical devices reflects an aggressive attitude on the part of the regulators that demands, in turn, that industry be keenly aware of the legal and regulatory duties, as well as key recent trends in enforcement activities by the Federal Government. This course will explore in detail what FDA requires of drug and device firms as well as recent current hot buttons in FDA enforcement activity for the advertising arena.
What’s at stake if your advertising and promotional efforts violate the law? Colossal fines – the latest was $3 Billion; criminal liability, including even prison time; and huge disruption in operations while dealing with federal probes into illegal marketing.
Learning Objectives:
Key goals of the conference will include learning:
The basics of FDA law and regulations governing advertising and promotion, as well as sister agencies such as the Federal Trade Commission, which shares jurisdiction with FDA on certain regulated products (e.g., OTC drugs).
The distinctions between labels, labeling and advertising and how that impacts FDA's powers, and
How to properly position Direct-to-Consumer (DTC) promotions
The Dos and Don'ts of promoting products on the internet, including social media sites such as Facebook and Twitter
The perils of off-label promotion, including criminal and civil actions that have led to multi-billion dollar settlements by regulated drug companies
Whether the First Amendment provides any insulation for truthful statements regarding regulated products;
When disseminating medical educational materials crosses the line into improper promotion; and
Key considerations on how to implement appropriate procedures and controls in your company to minimize the potential for regulatory action by the FDA or the FTC relative to promotion and advertising.
- Time:
- 12:30am-2:00am
- Description:
- Globalskywatch.com is a website documenting news and information about stratospheric geoengineering. there is a guest speaker and then open mike to discuss problems and concerns about the climate mitigation program.
- Time:
- 3:00pm-4:00pm
- Description:
- This webinar highlights key elements of Anti-Money Laundering (AML) requirements for broker-dealers and what employees should be aware of in order to identify and report potential money laundering activity.
Why Should You Attend:
Although financial institutions, including broker-dealers have had to comply with AML requirements under the USAPA for over ten years and the BSA for over four decades, recent cases have occurred involving major financial institutions that were found by regulators to have had inadequate controls in place to prevent money laundering. In some cases, firms were found to be complicit in facilitating transactions on behalf of clients seeking to conceal illegal activities.
Had the “red flags” in such instances been identified, reported to appropriately designated officers within the firms as well as law enforcement authorities, the resulting fines, penalties and reputation damage could have been avoided.
This session highlights the requirements for broker-dealers under the law and covers the types of activities that employees should recognize as suspicious and trigger the reporting process. You will learn how to evaluate the risk in establishing and/or maintaining a business relationship with a customer.
Areas Covered in the Webinar:
-Principles of the Bank Secrecy Act
-Principles of the USA PATRIOT Act
-Principles of FINRA Rule 3310
-Red Flags: Due Diligence on Establishing New Business Relationships
-Red Flags: Customer Identification Programs
-Red Flags: Monitoring, Detecting and Reporting Suspicious Activity
-Each of these areas are examined in terms of their
.Content
.Meaning
.Employee Responsibilities
Who will benefit:
This training will benefit companies and personnel in the securities market. Titles include:
-Broker-Dealer Sales Personnel
-Broker Dealer Supervisory Principals
-Securities Representatives and Principals
-Business Managers
-Compliance Analysts
-Operations Personnel
-Non-Registered Administrative Personnel
- Time:
- 3:00pm-4:10pm
- Description:
- This HR compliance training will provide the attendees best practices for handling Department of Labor audits.
Why Should You Attend:
The Department of Labor (“DOL”) has been on what appears to be a quest to knock on as many doors and industries as possible. The quest is a search for violations of overtime laws, minimum wage laws, exempt status and independent contractor status. The investigations are both costly and time consuming. Most employers do not know their rights and make critical errant omissions in the first few minutes of the investigation.
This course will help companies learn what to do when the DOL comes knocking. What you do in the first few minutes can save you thousands of dollars.
Areas Covered in the Webinar:
-Are they legitimate – ask questions.
-Do you need to turn over your documents or answer questions right away?
-Get prepared – maintain a defense.
-What happens during an investigation?
-What is the DOL looking for?
-How do you respond and what documents are you required to keep?
-The best defense is a good offense.
-How do we change things going forward?
Who Will Benefit:
-Business Owners
-Human Resource Managers
-Compensation Analysts
-Accountants and Advisors to Corporations
Instructor Profile:
Julie A. Proscia is a partner in SmithAmundsen’s St. Charles office and a member of the firm’s Labor and Employment Practice Group. Ms. Proscia concentrates her practice in both employment litigation and traditional labor issues. She has extensive experience representing employers in federal, state and administrative venues, including a trial practice at the Illinois Human Rights Commission, National Labor Relations Board and Department of Labor. Her trial experience ranges from discrimination and retaliation to non-competition/non-solicitation, wage, hour and unfair labor practices issues. Julie also actively assists employers and human resource professionals in the legal pitfalls of the employment relationship including the hiring process, policies and procedures, employee handbooks, employment agreements and the termination/separation process.
Prior to joining SmithAmundsen, she worked in the Human Resources Department of Northern Illinois University as the Assistant Director of Affirmative Action and Legal Compliance. While in law school, she also gained experience in employment law while working in the litigation division of the Equal Employment Opportunity Commission (EEOC). In 2012, she was named one of the top 40 Under 40 attorneys to watch in Illinois by the Chicago Daily Law Bulletin and the Law Bulletin Publishing Company.
- Time:
- 8:00pm-8:40pm
- Description:
- Steps Your Business Can Take to Mitigate the Risks and Ensure a Smooth Transition to The Cloud
This webinar is for executives who are serious about cloud computing, but are unsure of how to securely and efficiently make the transition.
We've done the reseach for you.
When researching cloud options, it's important to understand the risks, bottlenecks, and productivity traps of moving to a cloud computing provider.
During this webinar, you'll learn:
1.The Signs It’s Time To Migrate To The Cloud
2.Steps To Managing Cloud Expectations
3.How to Identify & Mitigate the Cloud Risks
4.How to Ensure a Smooth Transition To The Cloud
(If you're a cloud computing beginner, you may want to start with our 'Cloud Computing 101' webinar)
- Time:
- 12:00am-12:45am
- Description:
- This teleseminar is for anyone considering ending their marriage and is looking for help in making the decision. In addition to discovering five ways to know if divorce is right for you, you'll find out two reasons why you may wan to act sooner rather than later and one surprising (and radical) suggestion that will bring clarity to your decision.
This event is at 7 p.m. ET Tuesday November 5, 2013.
- Time:
- 1:00am-4:00am
- Description:
- Shalonda 'Treasure' Williams is honored to invite you to the Motivation For Today Empowerment Call. Every Wednesday night at 9 p.m. EST, you will join Coach Treasure, as she is affectionately called, as she equips, inspires, motivates, encourages and even challenges you to live out your best life yet! The life where you know just who you are and what you have to offer! Each week there will be a different topic fir to empower You to T.A.P. into your true worth... Spirit! Soul! & Body! Join us on facebook for a daily dose of motivation and for call updates!
- Time:
- 2:00am-3:20am
- Description:
- The majority of entrepreneurs realize that being on social media is crucial, however many are confused about how to actually utilize social media in ways that will grow their business and increase their cash flow. Having a presence on social media alone, such as creating a Facebook and Twitter account, is not going to build you the social influence you need to attract more business in order to increase cash flow.
In order to help you understand more about how to build social influence faster and more effectively, we invite you to listen to our free teleseminar, “Social Influence: Going Beyond Social Media to Grow Your Business,” which explains:
How to avoid the five (5) common mistakes entrepreneurs frequently make with social media
What social influence tools are available above and beyond the popular social media networks
How to position yourself as a “thought-leader” in your niche and increase your business
- Time:
- 2:00pm-6:00pm
- Description:
Wherever you are, this unique online video stream will bring you LIVE to our conference meeting room in Austria Trend Parkhotel Schönbrunn.
- Time:
- 3:00pm-4:30pm
- Description:
- This 60 minute webinar on how to deal with psychiatric disabilities at work addresses w.r.t. both the legal and psychological issues that often arise. The session covers confidentiality, fitness for duty evaluations, when and why to drug test, the relationship between conduct problems and mental illness, and how to directly address mental health problems with managers and employees.
Why Should You Attend:
The recent amendments to the A.D.A. have a significant impact on the rights of mentally employees as well as the responsibilities of employers. To make matters more confusing, the A.D.A., the F.M.L.A., and worker’s comp can intersect, or supersede, each other when it comes to dealing with psychiatric disabilities.
This webinar will help HR professionals understand how to navigate the difficult and often murky challenge of dealing with \"invisible disabilities.\" To make matters more confusing, the recent amendments to the A.D.A. have a significant impact on the rights of mentally ill employees as well as the responsibilities of employers.
At the end of this webinar the speaker will handle your specific questions related to the topic.
Areas Covered in the Webinar:
-When do conduct problems become mental illness?
-What do you say to a depressed employee?
-What protection do alcoholics and substance abusers have under the A.D.A.?
-How do you handle threats and other disruptive behavior?
-How do you avoid the 5 biggest mistakes managers make in managing mentally ill employees?
-What do you do when an employee talks of suicide?
-How do you handle an employee who comes back from rehab?
Who will Benefit:
-Senior HR Professionals
-HR Analysts
-HR Managers & Directors
-HR Personnel
-Managers & Supervisors
-Employee Relations Professionals
-Employee Assistance Professionals
-Directors, Vice Presidents & Managers of Recruiting/Retention
-Directors, Vice Presidents & Managers of Human Resources
-Employment Managers/Specialists
- Time:
- 3:00pm-4:30pm
- Description:
- This training on trade compliance will help the attendees understand the rules to qualify your imports/exports between United States, Mexico, and Canada. You will also learn best practices on how to complete the NAFTA certificate of origin to avoid penalties.
Why Should You Attend:
NAFTA is the largest free trade agreement between the United States, Mexico, and Canada. The NAFTA provides for the entry of goods duty-free into each of the countries provided that the goods meet the strict rules of origin in the agreement. A NAFTA Certificate of Origin is required for most goods that can qualify under the rules and must be completed by the exporter and in possession of the importer when the goods are entered into the importing country.
This webinar will help you understand how to meet the rules that are required to qualify your imports/exports between the three NAFTA countries (United States, Canada, and Mexico). It will also assist you in properly completing the NAFTA Certificate of Origin for qualified goods in order to receive duty-free treatment. Examples will be presented of each of the rules and instructions for completing the NAFTA Certificate of Origin. It will help you in preventing errors that could result in severe civil and/or criminal penalties imposed by each country's Customs administration and preparing for a NAFTA audit.
Areas Covered in the Webinar:
-Overview of NAFTA Agreement
-General Rules of Origin A through F
-Completion of NAFTA Certificate of Origin
-Recordkeeping Requirements
-Questionnaires, Verifications, and Audits
-Penalties
-Resources
Who Will Benefit:
-Importers, Exporters, and Manufacturers/Suppliers
-Purchasing Personnel
-Accounting Personnel
-Shipping/Receiving Personnel
-Customers
-Sales/Marketing Personnel
-Engineering/Manufacturing Personnel
-Freight Forwarders/Customhouse Brokers
-Consultants
-Attorneys
-Compliance personnel qualifying goods under NAFTA
- Time:
- 3:00pm-4:30pm
- Description:
- Overview: This Webinar covers an important new development in the banking industry - the emergence of the Banking Industry Architecture Network (BIAN), which is defining a standardized service-oriented architecture for banking. The banking industry is notable for its heavy reliance on banks' own IT organizations to develop and maintain enterprise software applications "in-house." In general, banks would like to invest less in software development and more in their core expertise.
However, it is not feasible for a large bank to switch overnight to vendors' packaged software in a "big bang." It is preferable to buy and integrate software packages and retire homegrown packages in a careful, staged fashion. Some of the homegrown packages will still be around for many years. Moreover, no vendor supplies software packages that account for all of a bank's needs. The barrier to the gradual changeover scenario has been the huge costs of integrating homegrown packages with packages from multiple vendors. BIAN was formed to address the integration problem. BIAN is developing standards to facilitate interoperability among heterogeneous software components within a bank's application landscape. BIAN's approach to standardization is somewhat unusual in that it focuses on semantic interoperability and not on defining technical wire-level interoperability formats.
In BIAN's formative period, some savvy people with experience as senior IT executives in the banking industry took a hard look at where the costs lie when integrating software packages. They agreed that the bulk of the effort and cost of integration lies in divergent understanding of the meaning of the data being integrated. Therefore, BIAN's founders came to a consensus that BIAN's service specifications should be at the level of the business semantics, and that technical service specifications, such as wire-level XML or REST formats, would be out of scope for BIAN. They felt strongly that if there is an agreement on the business semantics of the common services, then the integration work needed to define the low-level service formats at implementation time would be relatively small; such an agreement contrasts with the typical situation where agreement on technical formats still leaves much room for interoperability problems because the modules being integrated are based on (sometimes subtly) different understandings of the business semantics.
Building on other standards, BIAN has come up with an innovative architecture for specifying the business semantics of common services, and has developed a tool for modeling services in accordance with the architecture.
Why should you attend: You will gain an architectural understanding of BIAN's approach to standardization and how it realizes the organization's commitment to focus on business semantics. You will come away better equipped to assess the importance of BIAN to your work. This Webinar differs from the Virtual Seminar entitled "The BIAN Service Landscape: An In-Depth View" in that it does not drill down into technical detail, but does help you gain insight at the architectural level regarding the techniques used to build the Service Landscape.
Areas Covered in the Session:
The origin of BIAN and the motives of its founders and members
Why BIAN focuses on business semantics rather than on low-level technical specifications
How BIAN identifies common service components, based on a service center model
An overview of the common service components that BIAN has identified
How BIAN describes service contracts in a manner that focuses on semantics
How BIAN's standardized semantic-level specifications can provide value to banks and banking software vendors despite the fact that BIAN does not produce lower-level technical interoperability standards
How each bank can assemble the standard services in its own way, such that the assembled landscape reflects the structure of its business
An overview of the BIAN Metamodel and UML Profile, including an explanation of the role that they play in the architecture and in the BIAN modeling tool
The effort BIAN is making to build a business vocabulary, in order to anchor the service specifications in clear business semantics
The relationship between BIAN standards and other key standards in the financial services industry such as ISO 20022, SWIFT, IFX, FpML, FIX, and OMG Finance
Who Will Benefit:
Chief Architects
Enterprise Architects
SOA Project Leaders
Senior Developers
Business Analysts
Business Architects
Speaker Profile:
David Frankel has over 30 years of experience as a programmer, architect, and technical strategist. He is recognized as a pioneer and international authority on the subject of model-driven systems and semantic information modeling. He has a wealth of experience driving companies and industry at large to successfully adopt strategic technologies.
He has an outstanding ability to communicate in technical mentoring situations, publications, and presentations. He has published two books and dozens of trade press articles, and has presented at many industry conferences. He has a reputation for facilitating collaboration that, along with his strong technical expertise, has led him to co-author a number of important industry software standards, including UML®, ISO 20022, BIAN, and the XBRL Abstract Model. He served terms as an elected member of the Object Management Group’s Architecture Board and Board of Directors.
The IT domains in which he has expertise include data integration, domain-specific languages, enterprise architecture, model-driven systems, semantic information modeling, semantic interoperability, service-oriented architecture, and software product lines. The business domains in which he has applied his technical expertise in recent years include financial services, ERP financials, and business reporting.
His most recent project involved setting up the service-oriented architecture and tooling framework for the Banking Industry Architecture Network (BIAN) standards organization, during his tenure as SAP’s Lead Standards Architect for Model-Driven Systems.
- Time:
- 3:00pm-4:30pm
- Description:
- This training on medical device supplier management will explain the elements of a supplier quality agreement and discuss practical steps for implementation.
Why Should You Attend:
Effective supplier management can help prevent problems and reduce their impact should they occur. With the increased emphasis on supplier management, you can expect strong coverage of this area during an FDA Inspection. The FDA's Quality System Regulation (QSR) explains how a device manufacturer must manage suppliers. This ranges from supplier evaluation and selection to control methods. One common approach uses a supplier quality agreement.
This 90-minute training will help you understand the FDA QSR requirements, good business practices, and the role of a supplier quality agreement. This webinar will help you set up an effective and FDA compliant supplier management system.
Areas Covered in this Webinar:
-FDA QSR Requirements for Purchasing
-The Supplier Quality Agreement
-Administrative Elements
-Compliance
-Manufacturing, Packaging, and Labeling
-Documentation and Records
-Storage and Shipment
-Change Control
-Non-Conformance, CAPA, and Complaints
-Auditing
Who will benefit:
This webinar provides valuable information for those involved in supplier management in the medical device industry.
People in the following roles can especially benefit from the knowledge in this webinar:
-Medical Device Quality Managers
-Regulatory Affairs Managers at medical device companies
-Risk Managers
-Medical Device Supply Chain Managers
-Purchasing Professionals
-Medical Device Supplier Management Team