Startup Youth Entrepreneur-in-Training: Month Tickets

Startup Youth Entrepreneur-in-Training: Month Tickets
Event on 2017-06-25 15:00:00
Order a Session ticket  Order a Year ticket Order a Pro ticket When: Saturdays from 3:00pm to 5:00pm Schedule: September: Motivation/Entrepreneurship Sep. 10: Why young people can be innovative, entrepreneurs Sep. 24: Career development and future goals  October: Problem/Solution Oct. 8: Problem identification and market research Oct. 22: Building a solution and business idea November: Networking/Leadership/Team Management Nov. 12: How to network effectively, communication skills Nov. 26: How to be a good leader and manage a team December: Branding Dec. 3: Importance of a brand and identifying a good vs. bad brand Dec. 10: Building a brand and logo creation January: Marketing/Sales Jan. 14: Marketing and promotion Jan. 28: Social media, digital marketing February: Finance/Revenues/Funding/Insurance Feb. 11: Financial management, bookkeeping, accounting Feb. 25: Revenue plan/business model and insurance March: Startup Youth Entrepreneurial Bootcamp (no sessions) April: Problem/Solution Apr. 8: Problem identification and market research Apr. 22: Building a solution and business idea May: Web Sessions/Coding May 13: Front end development, Web design and development May 27: Back end development, how to code apps and website June: Business Plan/Strategy Jun. 10: Create a business plan Jun. 24: Create a pitch deck and practice pitching July: Pitches Jul. 8: Pitches (1st half) Jul. 15: Pitches (2nd half)

at Startup Canada HQ
56 Sparks Street , Suite 300
Ottawa, Canada

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Marketing Strategy and Tactics for Small Business

Marketing Strategy and Tactics for Small Business
Event on 2017-07-25 11:00:00
Marketing Strategy and Tactics for Small Business All businesses start with the intention of becoming successful, and most of those businesses start with a product or service that could get them there, but after a few years, many of those same businesses struggle to find success. How could this be? One main reason could be that they started without a marketing budget or plan. They don’t understand marketing and they don’t understand how important marketing is in making their business a success. This class will cover: Marketing basics Driving awareness of your business, product or service Elements of a marketing plan Goal planning Marketing budget planning Online marketing, including search and Search Engine Optimization (SEO) Tactics including a focus on social media planning Innovation and Ideation After taking this class, you should understand the basics of marketing, the definition of an impression, the goals of an impression and the types of general tactics that you can use to help drive awareness. You should be able to develop your own marketing strategy with goals, tactics, timelines and costs. You should understand the basics of search, SEO and social media. Finally, you should understand the importance of ideation and innovation for the future success of your business.

at Collin College Courtyard Center
4800 Preston Park Blvd.
Plano, United States

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Unknown – Spa Night


Unknown – Spa Night
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Price: USD 7.99
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SEO LAB with Hipreneur

SEO LAB with Hipreneur
Event on 2017-08-16 18:30:00
SEO (Search Engine Optimization) has become a vital component of inbound marketing. It's vital for businesses to appear on the front page of search result rankings to generate business and for brand exposure. Hipreneur’s LAB SEO Workshop is designed to give you specific steps you can take to optimize your website. DURING THIS WORKSHOP, YOU WILL LEARN: How Google works How to discover how your prospects search for your services online How to “audit” your competitor’s websites How to identify areas in your industry with massive opportunity On-page best practices Site design and architecture SEO best practices for Blogging You will leave this workshop with a customized plan in place and action steps you can implement immediately to help your website rank higher online. INSTRUCTOR ELLIOT SALTZMAN HIPRENEUR  |  @HIPRENEUR  |  HIPRENEUR.COM Hipreneur is owned and operated by Elliot Saltzman. Elliot understands how to generate new business and is an expert in sales. As a college student, Elliot made over ,000 in 10 weeks selling door-to-door for a summer job. At 22, he was appointed VP of Sales & Marketing for a startup construction company and grew sales to 2.2 million in the first 9 months. During his time in sales, he quickly became passionate about studying different tactics and strategies companies use to acquire new business. Over the past 6 years, Elliot has connected with over 2,000 small business owners and has learned the best ways to getting the “phone to ring,” as well as the common mistakes small businesses make “burning money” on non-revenue producing tactics. Elliot is passionate about speaking and training on business growth and in 2012, wrote a book called “How to become a Million Dollar Speaker” which has recently been seen in Success Magazine.

at LAB Headquarters @ Loring Corners
1624 Harmon Place
Minneapolis, United States

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Ted Nugent ı The Cotillion July 7

Ted Nugent ı The Cotillion July 7
Event on 2017-07-07 20:00:00
TED NUGENT
FRI, JULY 7, 2017
DOORS: 7:00 PM
ADVANCE – DAY OF SHOW
ON SALE FRI 4/14 10:00 AM CDT
THIS EVENT IS ALL AGES
All seating is general admission. Table reservations are available at The Cotillion or by calling 316-722-4201. Nancy's A-Maize-N Sandwiches will be here serving her Famous #8 and more! Text ROCK to 49798 for updates and chances at FREE tickets! The Check Room is open during events to check your coats, hats and purses.
Ted Nugent has carved a permanent place in rock & roll history as the ultimate guitar-shredding showman, selling more than 40 million albums, performing over 6,500 high-octane live shows, and continuing to set attendance records at venues around the globe.
Nugent was named Detroit’s Greatest Guitar Player of All Time by readers of MLive, and his no-holds-barred career spans five decades of multi-platinum hits. From the ground breaking Amboy Dukes' hit "Journey to the Center of the Mind," to classics like "Stranglehold" (ranked in the Top 100 Classic Rock Songs and #1 Guitar Lick), "Cat Scratch Fever," (32nd Best Hard Rock Song of All Time) Damn Yankees chartbuster "High Enough," and cult classic "Fred Bear,” (the most requested song for radio airplay in Michigan & Wisconsin), Ted and his inimitable sound have been featured on VH1’s Behind the Music, A & E’s Biography and more.
For millions of passionate music lovers everywhere, Ted delivers the Ultimate Life Soundtrack. A Ted Nugent show is not just a performance—it’s a firebreathing celebration!

at The Cotillion
11120 West Kellogg
Wichita, United States

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Rocks Digital Marketing Conference 2017

Rocks Digital Marketing Conference 2017
Event on 2017-06-29 09:30:00
The anticipated date and time has arrived! Registration for the 2017 Rocks Digital Marketing Conference is NOW OPEN! Register NOW for the 6th annual conference that starts June 29 and June 30, 2017 Bernadette Coleman and Lissa Duty, the conference organizers, are excited to invite you to this year’s Dallas based annual Local Search and Social Media Day celebration. The fun starts on June 29 and last through June 30 (Social Media Day)! Attendees will learn from local search influencers from around the world!  June 29 – We will kick off the day with all the attendees gathering together in the morning for six high impact presentations! Then we’ll go into three rounds of break-outs, before coming back together to wrap up the day with three closing presentations, including a keynote address. June 30 – Features nine after-conference workshops for attendees to select from. All the workshops focus on real-world education and strategies around the topics of Local Search and SEO, Social Media, Paid Media, Google Analytics and Content Marketing. Register for one day or both! The earlier you register the more you save.   What to Expect at Rocks Digital 2017 25+ Speakers and Sessions 4 Keynote Addresses 9 Information Packed Break-Out Sessions 8 Merged-Room Presentations 9 Workshops  Back by Popular Demand Rocks Talks – High-Energy High-Impact Digital Strategy featuring 4 Experts Local Search Day Expert Panel, with moderator, Bernadette Coleman  Special After-Event includes:  Social Media / Local Search Day Tweetup Business owners, brand mangers and digital marketers from agencies and enterprise corporations around the United States will converge on Dallas, Texas for this national digital marketing conference on June 29 to June 30. Register NOW! We ROCK Content, Search, Social, Local and Business Development! Conference, Location, Date & Times Addison Conference Center, 15650 Addison Rd, Addison, Texas, TX 75001. (972) 450-6241 (Located off the North Dallas Tollway & Beltline Road) Thursday, June 29 (Local Search and Social Media Day Conference) Friday, June 30 (Workshops) Registration Opens 8:30 am | Welcome 9:30 am | Ends 6:00 pm After-Event Immediately Following Onsite June 29 Rocks Digital Marketing Speaker SamplingKaren Liz Albert | Lance Bachmann | Dave Carberry | John Carroll | Bernadette Coleman | Lissa Duty | Damon Gochneaur | Danielle Hanson | Bill Hartzer | Moosa Hemani | Byron Ingraham | Beth Kahlich | Katy Katz | Dean Lindsay | Chris Marentis | Casey Markee | Brad McCormick | Hillit Meidar-Alfi | Robin Moss | John Nosal | Jayne Rios | J Schuh | Erik Solan | Greg Sterling | Mike Stewart | Michelle Stinson Ross | Lex ten Veen | Dan Thies | Dan Tyre | DeAndre Upshaw | Jeff Whitfield | Joe Youngblood *Lunch included with your ticket price on June 29. Afternoon snacks will be provided. Cash bar available for after-event. Questions? Email Lissa@RocksDigital.com. Register Now | Read Reviews | Meet Our Speakers | Meet Our Sponsors | Become a Sponsor  Ticket Policy: Tickets are non-refundable and non-transferable. Contact the organizer for questions or concerns prior to registering for the event. Speakers, presentation descriptions and session times are subject to change. By purchasing this ticket you agree to the following: In the event that Rocks Digital Marketing Conference cancellation occurs, you will be eligible for a refund of the price paid for your ticket. The ticket price refund represents your sole remedy for any losses you might incur as a result of cancellation. You agree that your likeness can be used in event promotion, at future events and shared on the Internet. 

at Addison Circle Park
15650 Addison Road
Addison, United States

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Simple Strategies To Maximize Your Practice’s Profitability

Simple Strategies To Maximize Your Practice’s Profitability
Event on 2017-07-14 10:30:00
Simple Strategies To Maximize Your Practice's Profitability  "How can healthcare professionals leverage the power of the internet to gain new patients, minimize wasted collections activities, better organize their time and resources, and manage/track patient referrals?" In this LIVE Q&A event, 3 industry experts are combining forces to discuss how healthcare practices can generate new patient leads, grow practice revenue at more rapid rates, and provide quality patient care through patient referral management systems. This event was specifically constructed for entrepreneurial minded healthcare professionals who would like to learn about the best strategies and solutions to maximize both their practice’s profitability, and client base.  Networking and light refreshments will be offered before the event officially begins. Presentations: 4 Site Digital Marketing Agency 4 Site Digital presents "Optimizing Patient Marketing: Proven Methods to Getting More Out of Your Digital Marketing and Your Web Presence."  Nearly 66% of Small Business Owners say that finding new customers is a top concern. Search Engine Optimization is essential for securing these desired new leads – “82% of local online searchers follow up with an offline contact such as a phone call, a visit to the store, or a purchase.” Are you missing out? Google  A Google internet strategy specialist will provide an enlightening guest presentation on need to know industry stats, trends, and impactful tools your business should be using.  Whether you are focused on brand building, patient education, or direct new patient marketing, the experts at Google will uncover a new tool to incorporate in your marketing mix. MEDINEXO® Presenting "How Much Time & Money Is Your Practice Losing By Poorly Handling Referrals?" Patient leakage is a real problem for practices’ bottom-line and it damages the patient experience. This session will enlighten healthcare professionals on simple web based solutions that will simplify these processes, allow professionals to know referrals are picked up, expedite consults with necessary diagnostics & records transfer, and load balancing options to make the most of your available time. PRECYM CEO Abdiel Louis presents, “How Your Practice Can Transform Its Ability To Get Paid As Quickly As Possible.” In this session we will explore internal and external factors facing practices of all sizes, including a methodical cost analysis of your current revenue cycle.  A number of health providers are recognizing that increasing their cash flow is critical for their success, but many struggle to reduce suspended claims, increase reimbursement and collection without increasing headcount. Beyond just tracking a claim, optimizing your revenue cycle management will help your practice become more profitable by identifying and fixing your historical data debt, denial percentage, claims submission, and payment posting.   For CIC Visitor Parking Instructions, Please View The Map Below.  For Additional Instructions on Parking or Directions Call: 314.236.9010  

at Cambridge Innovation Center (CIC) – Venture Cafe
4240 Duncan Ave
Saint Louis, United States

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Statistical Methods A Visual Approach 2017

Statistical Methods A Visual Approach 2017
Event on 2017-08-03 09:00:00
Course "Statistical Methods: A Visual Approach" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

An essential task in any compliance analytics workflow is to not only explore your data visually, but also to communicate your results professionally with graphic displays. Do you have the tools and skills to quickly and thoroughly perform these tasks? This course in data visualization will present methods to allow you to interactively discover relationships graphically. We will provide the foundations for creating better graphical information to accelerate the insight discovery process and enhance the understandability of reported results. First principles and the "human as part of the system" aspects of information visualization from multiple leading sources such as Harvard Business Review, Edward Tufte, and Stephen Few will be explored using representative example data sets. We will discuss best practices for graphical excellence to most effectively, clearly, and efficiently communicate your story. We will construct visualizations for univariate, multivariate, time-dependent, and geographical data. Participants are encouraged to bring laptops to follow along demonstrations in JMP (free trial download at www.jmp.com), and open source solutions such as R (https://www.r-project.org) and Tableau Public (https://public.tableau.com/s/).

Why you should attend:

Data-driven decisions across all regulated industries are now expected. Compliance regulations require analytic solutions that begin with data visualization for discovering relationships and finish with crisp graphs communicating results. As an example, 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries specify the application of statistical methods for: setting validation criteria and specifications, performing measurement systems analysis (MSA), conducting stability analysis, using design of experiment (DOE) for process development and validation, developing process control charts, and determining process capability indices. Data visualization is the foundation for each one of these areas. In some cases, graphical plots and tables alone may sufficiently address compliance criteria as is the case for the FDA analytical requirements for third-tier critical to quality attributes for analytical biosimilarity evaluations. Data visualization is also essential in other areas such as HIPAA compliance, risk management and analysis, and many other of the quality functions.

Who Will Benefit:

• Data Analysts
• Research Scientists
• Quality Professionals
• Regulatory/Compliance Professionals
• Laboratory Managers
• HR Professionals
• Project Managers
• Design and Development Engineers
• Software Engineers
• Process Owners
• Quality Engineers
• Quality Auditors
• Medical Affairs Professionals
• Process Scientists/Engineers

Agenda:

Day 1 Schedule

Lecture 1:
• Introduction and definitions
• Examples of data visualizations for compliance and regulated industries
• Historical context
• Characteristics of data
• Interactive data visualization exploration with Excel and websites

Lecture 2:
• Human side of data visualization
• Principles of good graphic design
• Data visualization methodology
• Best practices

Lecture 3:
• Software introduction: JMP
• Univariate plots
• Distributions and histograms
• Pie graphs, violin plots, pareto plots, box plots
• Conditional formatting

Lecture 4:
• Mulitvariate plots and heatmaps
• Correlation
• Multivariate scatterplots and density graphs
• Contour plots
• Categorical data plots: treemaps, mosaic plots

Day 2 Schedule

Lecture 1:
• Software introduction: R
• Software introduction: Tableau Public
• Univariate plots with R and Tableau
• Multivariate plots with R and Tableau

Lecture 2:
• Dynamic and interactive graphs
• Brushing, dynamic linking, and filtering
• Profilers on response variables and optimization

Lecture 3:
• Time series plots
• Waterfall plots
• Sparklines and trend lines
• Statistical Process Control charts

Lecture 4:
• Maps
• Text data visualization
• Dashboards
• Course summary

Speaker
James Wisnowski

James Wisnowski is the cofounder of Adsurgo LLC and co-author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP. He has over 25 years of experience and currently provides training and consulting services to industry and government in Design of Experiments (DOE), Reliability Engineering, Data Visualization, Predictive Analytics, and Text Mining. Dr. Wisnowski has been an invited speaker on applicability of statistics for national and international conferences. Prior to his current position, he was a senior program manager for URS, Chief of the Statistics Division in the Mathematics Department at the Air Force Academy, and a retired military officer. He is currently a member of the editorial board of Quality Engineering and has published numerous international refereed journal articles on statistics. Jim has a PhD in Industrial Engineering from Arizona State University.

Location: Raleigh, NC Date: August 3rd & 4th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: Courtyard Raleigh-Durham Airport 2001 Hospitality Ct, Morrisville, NC 27560, United States

Price:

Register now and save 0. (Early Bird)
Price: ,295.00 (Seminar Fee for One Delegate)
Until June 20, Early Bird Price: ,295.00 From June 21 to August 01, Regular Price: ,495.00
Register for 5 attendees Price: ,885.00 ,475.00 You Save: ,590.00 (40%)*
Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar
At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.
As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.
For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
support@globalcompliancepanel.com
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com

Registration Link – http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901114SEMINAR?eventful-August-2017-SEO

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/
Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/
Follow us on Twitter: https://twitter.com/GCPanel

at Courtyard Raleigh-Durham Airport
2001 Hospitality Ct, Morrisville, NC 27560, United States
Morrisville, United States

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HIPAA Privacy and Security Time to get Serious 2017

HIPAA Privacy and Security Time to get Serious 2017
Event on 2017-08-03 09:00:00
Overview:

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 specific experiences from over 17 years of experience in working as an outsourced compliance auditor, expert witness on multiple HIPAA cases, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information.
More importantly I will show you how to limit those risks by simply taking proactive steps and utilizing best practices.

Why you should attend:

Omnibus has changed the HIPAA landscape for good!
This once rarely enforced law has changed and you need to know what's going on!
Protect your practice or business!
These days trial attorneys pose a higher risk than the Federal government!
State laws are now in place increasing liability for patient remedies!
What factors might spurn a lawsuit or a HIPAA audit? …Are you doing these things?
Why are the Feds enforcing after all these years?
We will be discussing 2017 changes taking place in Washington with the Health and Human Services in regards to the enforcement of the HIPAA laws already on the books as well as some detailed discussions on the Phase 2 audit process as well as some current events regarding HIPAA cases (both in courtrooms and from live audits)

Areas Covered in the Session:

• History of HIPAA
• HITECH
• HIPAA Omnibus Rule
• How to perform a HIPAA Security Risk Assessment
• What is involved in a Federal audit and how is it conducted
• Risk factors for a federal audit
• EHR and HIPAA
• Business Continuity/Disaster Recovery Planning
• Business Associates and HIPAA
• In depth discussions on IT down to the nuts and bolts
• BYOD
• Risk factors that can cause an audit (low hanging fruit)
• New rules which grant states ability to sue citing HIPAA on behalf of a patient
• New funding measures
• …much, much more.

Who Will Benefit:

• Practice Managers
• Compliance Officers, and any Business Associates Privy to Private Health Information and Under the Auspices of this Law.

Agenda:

Day 1 Schedule

Lecture 1: HIPAA Privacy Rule vs HIPAA Security Rule
Lecture 2: HITECH Act
Lecture 3: HIPAA -History
Lecture 4: Information Technology
Lecture 5: Breach Notification Rule
Lecture 6: Omnibus Rule
Lecture 7:Business Associates
Lecture 8: Current Court Cases (precedence)
Lecture 9: Paper Based PHI Concerns
Lecture 10: Disaster Recovery Concerns (Paper)
Lecture 11: Psych and Infectious Disease

Day 2 Schedule

Lecture 1: BYOD
Lecture 2: Texting and Emailing
Lecture 3: Choosing a HIPAA Consultant
Lecture 4: Choosing an IT Group
Lecture 5: Disaster Recovery Concerns (Electronic)
Lecture 6: Physical Setup
Lecture 7: Overseas Outsourcing
Lecture 8: What the Feds are Looking For (low hanging fruit)
Lecture 9: What are Factors That Can Get Your Practice Audited
Lecture 10: State Laws and Patient Ability to Sue
Lecture 11: How to Conduct a Risk Assessment
Lecture 12: How to Write Policies and Procedures

Speaker
Brian L Tuttle
Sr Compliance Consultant & IT Manager, InGauge Healthcare Solutions

Brian L Tuttle, CPHIT, CHP, CHA, CBRA, CISSP, CCNA
Brian Tuttle is a Certified Professional in Health IT (CPHIT), Certified HIPAA Professional (CHP), Certified HIPAA Administrator (CHA), Certified Business Resilience Auditor (CBRA), Certified Information Systems Security Professional (CISSP) with over 17 years' experience in Health IT and Compliance Consulting.
With vast experience in health IT systems (i.e. practice management, EHR systems, imaging, transcription, medical messaging, etc.) as well as over 17 years' experience in standard Health IT with multiple certifications and hands-on knowledge, Brian serves as compliance consultant and has conducted onsite and remote risk assessments for over 1000 medical practices, hospitals, health departments, insurance plans, and business associates throughout the United States.
In addition, Mr Tuttle has served in multiple litigated court cases serving as an expert witness offering input related to best practices and requirements for securing and providing patient access to protected health information. Mr. Tuttle has also worked directly with the Office of Civil Rights (OCR) both in defending covered entities and business associates as well as being asked by the Federal government to audit covered entities and business associates on behalf of the OCR.
Almost all of Brian's clients are earned by referral with little or no advertising.
Brian is well known and highly regarded in medical circles throughout the United States for his quality work and down home southern charm.
Mr. Tuttle has a Master's Degree in Health Sciences from Georgia State University.

Location: Raleigh, NC Date: August 3rd & 4th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: Courtyard Raleigh-Durham Airport 2001 Hospitality Ct, Morrisville, NC 27560, United States

Price:

Register now and save 0. (Early Bird)
Price: ,295.00 (Seminar Fee for One Delegate)
Until June 20, Early Bird Price: ,295.00 From June 21 to August 01, Regular Price: ,495.00
Register for 5 attendees Price: ,885.00 ,475.00 You Save: ,590.00 (40%)*
Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar
At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.
As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.
For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
support@globalcompliancepanel.com
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com

Registration Link – http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901042SEMINAR?eventful-August-2017-SEO

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/
Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/
Follow us on Twitter: https://twitter.com/GCPanel

at Courtyard Raleigh-Durham Airport
2001 Hospitality Ct, Morrisville, NC 27560, United States
Morrisville, United States

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FDA Effective Regulatory & Quality Submissions 2017

FDA Effective Regulatory & Quality Submissions 2017
Event on 2017-08-03 09:00:00
Course "FDA Legal Writing Skills that Result in Effective Regulatory & Quality Submissions" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on arcane scientific and technical arguments. Because regulations are legally binding requirements predicated upon statutory laws and judicial opinions, it is essential that professionals in the pharmaceutical and medical device companies clearly understand and effectively employ legal writing techniques to frame persuasive argument when negotiating with FDA. The success or failure of many new drugs, biologic or medical device projects hinge on presenting essential information in a persuasive manner. Do you use these legal drafting skills when preparing quality and regulatory documents?
In this seminar, you will learn the legal writing skills and practical techniques that will enhance your chances for success even if some of your test results or other supporting information are somewhat lacking. Remember, good regulatory writing will meet FDA branch-level requirements but the best and most effective submissions can withstand scrutiny at the FDA Division level.

Why you should attend:

Most regulatory, quality and R&D professionals rise within an organization due to their scientific and technical understanding of the products in their company's pipeline. However, those professionals who can prepare written and oral arguments that effectively persuade regulatory agencies to agree with their positions are the one who achieve the highest levels of success within the organization. Lawyers know these writing techniques – do you?

Areas Covered in the Session:

• Basic communications skills that all successful attorneys use to win arguments, in legal briefs and oral presentations.
• Step-by-step analysis of how to present both good and poor data in a persuasive manner.
• How to train scientists and engineers to generate "good" data to support legal, regulatory and quality claims
• Tips and secrets to framing an argument that makes even poor data look good.
• Examples of good writing that can be useful templates for training and skills development.
• What you should never say in a quality or regulatory document

Who Will Benefit:

The seminar will be valuable to any person working in Regulatory Affairs or Quality Management who is responsible for summarizing data and technical results, obtaining regulatory clearance or approval of a product, and selling or marketing regulated products.
• Regulatory Affairs professionals
• Quality Assurance professionals
• Marketing professionals
• Scientific and Engineering / Product Development Managers
• Consultants to any regulated industry

Agenda:

Day 1 Schedule

Lecture 1:
• Day 1: Brief Introduction to Seminar Topics
o Summary of Day 1 Agenda – Training Objectives, Processes and Deliverables
• Regulatory Affairs & Administrative Law: Public Policy & Legal Objectives
• Hallmarks of Effective Legal Representation: Serving the Public while Meeting Client Needs
• Strategic & Tactical Approaches toward Satisfying the Law, Agency Policies and Client objectives – A Practical Summary
• Day 2: Legal Writing Skills Development: Best Practices
o Summary of Day 2 Agenda – Training Objectives, Processes and Deliverables
• Legal Writing in Quality System Development; Policies, SOPs and Reports; Responses to FDA 483 Inspectional Observations
• Legal Writing in Premarket Product Development; Design Control & Quality-by-Design (Q-b-D); Drug & Biologic IND, medical device IDE and FD&C Act § 510(k)
• Legal Writing in Postmarket Product Development; New Drug Applications, Biologic License Applications, Premarket Approval Applications; Postmarketing Changes (CBE-30, PAS)
• Strategic & Tactical Approaches toward Satisfying the Law, Agency Policies and Client objectives – A Practical Summary

Lecture 2:
• Step 1 to Persuasive Legal Writing: Understand the Basic Principles
• Introduction to Administrative Law & Legal Argumentation
o Legal Principles 101 and Applicability to Regulatory Compliance
o Legal Writing: Theory and Practice
o How to Address & Resolve Issues in Contention
 IRAC – Issues, Rules, Analyses & Conclusions
o Agencies are bound by Rules; Learning to Work within FDA Restrictions

Lecture 3:
• Hallmarks of Effective Legal Representation: Serving the Public while Meeting Client Needs
• Finding applicable law: Acquiring "Arrows in your Quiver"; Data and decisions that support your legal argument.
o Statutory law, regulatory requirements, relevant case law, agency rulings, Guidance for Industry, and Industry consensus standards

Lecture 4:
• Strategic & Tactical Approaches toward Satisfying the Law, Agency Policies and Client objectives – A Practical Summary
o Break out Sessions – Applying Legal Writing Principles to Meet Regulatory Objectives
 Case studies assigned to groups;
 Draft IRAC responses to persuasively address issues

Speaker
Robert J Michalik

Robert J Michalik, J.D.., RAC, is a Massachusetts regulatory attorney and founder of RegulatoryPro.com, a consulting firm providing general and specialized services to the biopharmaceutical and medical device industries.
Mr. Michalik has over 25 years' experience working in the biopharmaceutical and medical device industries. Starting with a bachelor's degree in science (biochemistry), Bob has held a wide variety of technical, quality and regulatory positions that literally span the scope of new product development and commercialization activities. For more than 10 years Mr. Michalik was an Adjunct faculty member with Northeastern University (Boston, MA) Master's Program in FDA Regulatory Affairs.

Location: Raleigh, NC Date: August 3rd & 4th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: Courtyard Raleigh-Durham Airport 2001 Hospitality Ct, Morrisville, NC 27560, United States

Price:

Register now and save 0. (Early Bird)
Price: ,295.00 (Seminar Fee for One Delegate)
Until June 20, Early Bird Price: ,295.00 From June 21 to August 01, Regular Price: ,495.00
Register for 5 attendees Price: ,885.00 ,475.00 You Save: ,590.00 (40%)*
Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar
At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.
As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.
For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!
NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
support@globalcompliancepanel.com
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com

Registration Link –http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901036SEMINAR?eventful-August-2017-SEO
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at Courtyard Raleigh-Durham Airport
2001 Hospitality Ct, Morrisville, NC 27560, United States
Morrisville, United States

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