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Upcoming Seminars


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  Aug 31st & Sep 1st, 2016
  • Boston, MA
  • 8:30 AM to 5:30 PM
  • Thomas E. Colonna

Global Medical Device Regulation

This course provides an overview of international medical device regulations. Beginning with a discussion of the similarity of global requirements, including both voluntary and mandatory standards and directives,

Registration      Download Seminar Brochure
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  15th & 16th,   September, 2016
  • Salt Lake City, UT
  • 9:00 AM to 4:30 PM
  • Ricardo Valls

Using lineament analysis in geological exploration

We will introduce you to an effective and affordable methodology that identifies prospective targets which are related to, or controlled by tectonic structures. Even over new areas with limited or nonexistent geological information we are able to help you concentrate your exploration efforts to keep your budget in the black.

Registration      Download Seminar Brochure
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  15th & 16th September, 2016
  • Boston, MA
  • 9 AM to 6 PM
  • Dan O'Leary

Implementing ISO 13485:2016

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).

Registration      Download Seminar Brochure
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  15th & 16th September, 2016
  • Salt Lake City, UT
  • 9 AM to 6 PM
  • Brian L Tuttle

HIPAA for the Compliance Officer

Areas covered will be history of HIPAA, privacy vs security, business associates, changes for 2016, audit process, paper based PHI, HIPAA and suing, texting, email, encryption, medical messaging, voice data and much, much, more

Registration      Download Seminar Brochure
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  15th & 16th September 2016
  • Salt Lake City, UT
  • 9:00 AM to 6:00 PM
  • Ronald L. Adler

HR Auditing: Identifying and Managing Key Risks

HR audits are designed to help your organization focus its attention on its human resource management practices, policies, procedures, processes, and outcomes by providing you with a structured and systematic series of questions about key compliance,

Registration      Download Seminar Brochure
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  22nd & 23rd September, 2016
  • Seattle, WA
  • 9 AM to 6 PM
  • David R Dills

Bullet Proof 510(k) and Latest FDA Proposed Changes to the Process

This Two-day course is a primer and overview to the premarket notification process, i.e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA.

Registration      Download Seminar Brochure
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  22nd & 23rd September, 2016
  • Washington, DC
  • 9 AM to 6 PM
  • Steven Walfish

Statistics for the Non-Statistician

Statistical tools and techniques are very commonly used to help measure and improve the quality of a firm's process and product. If statistical analysis is not properly performed and/or understood, a firm can run the risk of distributing the kind of product to the market that ultimately fails, resulting in lost time and money.

Registration      Download Seminar Brochure
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  29th & 30th September, 2016
  • San Diego, CA
  • 9 AM to 6 PM
  • Paul Hales

Master HIPAA Compliance in Six Steps

This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2016.

Registration      Download Seminar Brochure
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  29th & 30th September, 2016
  • San Diego, CA
  • 9 AM to 6 PM
  • Gregory J. Simms

A Complete Guide For Practice To Set Up A Durable Medical Equipment Revenue Program and Be Legally Compliant

Your Practice can develop a new revenue stream from your existing patient base by providing braces & pain management solutions right from your own office! Fully compliant with federal and state regulations. You're already creating DME revenue - Why not keep it for your practice?

Registration      Download Seminar Brochure
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  29th & 30th September, 2016
  • San Diego, CA
  • 9 AM to 6 PM
  • Susan Fahey Desmond

Conducting Internal Investigations

It seems that employees love to complain about anything, and it seems impossible to investigate everything. When employees feel, however, that you are not taking their complaints seriously enough or that you are ignoring them, they will find external sources for their complaints.

Registration      Download Seminar Brochure
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  29th & 30th September, 2016
  • San Diego, CA
  • 8:30 AM to 5:30 PM
  • Chris DeVany

Leadership and Team Development for Managerial Success

Managers who will be promoted are the ones who not only manage efficiently but also lead their teams effectively. Learn how to work in a horizontal mode of operation.. apply a consistent theory in leading your team.. and teach critical leadership skills to members of your team, so each and every one of them can lead the team in your absence.

Registration      Download Seminar Brochure
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  6th & 7th October, 2016
  • Baltimore, MD
  • 9 AM to 6 PM
  • David R Dills

How FDA Trains Its Investigators and Inspectors to Review Sub-Systems for State of Compliance: What You Need to Do to Prepare for a Successful Inspection

Think like and behave like an FDA investigator and recognize your greatest risks and vulnerabilities. Your authority to enter and inspect establishments is predicated upon specific obligations to the firm per FDA's documentation and we will review in detail.

Registration      Download Seminar Brochure
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  6th & 7th October, 2016
  • Washington, DC
  • 9 AM to 6 PM
  • David Rohlander

Strategies for Effective Leadership

We engage most of your senses. You will read short lessons, write action plans, discuss issues with others, ask questions and provide answers as well as make and keep commitments to yourself and the group.

Registration      Download Seminar Brochure
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  6th & 7th October, 2016
  • Washington, DC
  • 9 AM to 6 PM
  • Harry Brull

Hiring the "Right Stuff" - Employee Selection Tools and Techniques

Employee selection and promotion is about predicting the future. At decision time, the questions to be answered are "How well will this individual function in the role?" and "how long will they stay?". Additional predictions might include "How much potential does this person have to take on additional responsibility?"

Registration      Download Seminar Brochure
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  13th & 14th October, 2016
  • SFO, CA
  • 9 AM to 6 PM
  • Angela Bazigos

Hosting Regulatory Inspections

The course will go through what typically goes on during an FDA inspection and will then cover how to prepare for, host and follow up to a regulatory inspection. It will focus the things that you should do or not do during the inspection.

Registration      Download Seminar Brochure
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  13th & 14th October, 2016
  • San Diego, CA
  • 9 AM to 6 PM
  • Dr. Steven Kuwahara

GMP and Regulatory Expectations for Early IND Products

Analytical and other equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability.

Registration      Download Seminar Brochure
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  20th & 21st October, 2016
  • San Diego, CA
  • 9 AM to 6 PM
  • David R Dills

FDA Inspection: Do's and Don'ts

Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer.

Registration      Download Seminar Brochure
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  20th & 21st October, 2016
  • Chicago, IL
  • 8:30 AM to 4:30 PM
  • Casper Uldriks

FDA's Tougher Regulation of Medical Device Software

Software pervades our lives. Likewise, the risks and vulnerabilities of software sneak into our lives. The use of software in medical devices or as a stand-alone product outpaces the FDA's ability to keep up with the technology and its uses. Software applications develop like a fountain of possibilities and leeks.

Registration      Download Seminar Brochure
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  27th & 28th October, 2016
  • Boston, MA
  • 9 AM to 6 PM
  • Ricardo Valls

New Way of Exploring Economic Environment in the Current Markets without Taking Risk

We will introduce you to an effective and affordable methodology that identifies prospective targets which are related to, or controlled by tectonic structures. Even over new areas with limited or nonexistent geological information we are able to help you concentrate your exploration efforts to keep your budget in the black.

Registration      Download Seminar Brochure
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  3rd & 4th November, 2016
  • Salt lake City, UT
  • 9 AM to 6 PM
  • Harry Brull

Hiring the "Right Stuff" - Employee Selection Tools and Techniques

Employee selection and promotion is about predicting the future. At decision time, the questions to be answered are "How well will this individual function in the role?" and "how long will they stay?". Additional predictions might include "How much potential does this person have to take on additional responsibility?"

Registration      Download Seminar Brochure
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  10th & 11th November, 2016
  • Chicago, IL
  • 9 AM to 6 PM
  • David R Dills

Bullet Proof 510(k) and Latest FDA Proposed Changes to the Process

This Two-day course is a primer and overview to the premarket notification process, i.e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA.

Registration      Download Seminar Brochure
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  10th & 11th November, 2016
  • Chicago, IL
  • 8:30 AM to 5:30 PM
  • Chris DeVany

Leadership and Team Development for Managerial Success

Managers who will be promoted are the ones who not only manage efficiently but also lead their teams effectively. Learn how to work in a horizontal mode of operation.. apply a consistent theory in leading your team.. and teach critical leadership skills to members of your team, so each and every one of them can lead the team in your absence.

Registration      Download Seminar Brochure
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  10th & 11th November, 2016
  • Chicago, IL
  • 9 AM to 4 PM
  • Ricardo Valls

Extracting information from geochemical data

Most specialists strongly recommend to sample every meter of the drill core or of a trench and to use multielement analysis, rather than just asking the laboratory for gold test. There are also many other types of analysis that are ignored by the industry. But even when such analyses are requested, most of the time the fed geologist is not well trained on the necessary techniques and methods to extract all the information contained in the data.

Registration      Download Seminar Brochure
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  17th & 18th November, 2016
  • Philadelphia, PA
  • 9 AM to 6 PM
  • Dr. Steven Kuwahara

Design of Experiments and Statistical Process Control for Process Development and Validation

Analytical and other equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability.

Registration      Download Seminar Brochure
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  17th & 18th November 2016
  • Los Angeles, CA
  • 9:00 AM to 6:00 PM
  • Ronald L. Adler

HR Auditing: Identifying and Managing Key Risks

HR audits are designed to help your organization focus its attention on its human resource management practices, policies, procedures, processes, and outcomes by providing you with a structured and systematic series of questions about key compliance,

Registration      Download Seminar Brochure
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  17th & 18th November, 2016
  • Los Angeles, CA
  • 9 AM to 6 PM
  • David Rohlander

Strategies for Effective Leadership

We engage most of your senses. You will read short lessons, write action plans, discuss issues with others, ask questions and provide answers as well as make and keep commitments to yourself and the group.

Registration      Download Seminar Brochure
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  21st & 22nd November, 2016
  • SFO, CA
  • 8:30 AM to 4:30 PM
  • Miles Hutchinson

The Complete Payroll Law

This course covers a very broad range of topics from worker classification, to employee classification, to establishing methods and rates of pay, what must be included in the rate of pay, hours that must be compensated as worked time, required benefits, de minimus working fringes,

Registration      Download Seminar Brochure
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  1st & 2nd December, 2016
  • Baltimore, MD
  • 9 AM to 6 PM
  • Steven Wachs

Statistical Process Control & Process Capability

This course teaches participants the fundamental concepts and methods needed to establish effective control charts and estimate process capability. In addition to learning traditional control charts (e.g. xbar, r/s), participants will be exposed to other useful charts for handling multiple sources of variation (within/between) and short production runs.

Registration      Download Seminar Brochure
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  1st & 2nd December, 2016
  • Baltimore, MD
  • 9 AM to 6 PM
  • Paul Hales

Master HIPAA Compliance in Six Steps

This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2016.

Registration      Download Seminar Brochure
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  8th & 9th December, 2016
  • Boston, MA
  • 9 AM to 6 PM
  • David R Dills

FDA Inspection: Do's and Don'ts

Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer.

Registration      Download Seminar Brochure
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