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Upcoming Seminars


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  26th & 27th May, 2016
  • SFO, CA
  • 9:00 AM to 6:00 PM
  • Casper Uldriks

Marketing Products Without Getting Hammered by FDA

With this seminar you will learn how to navigate FDA's legal requirements and its interpretations for enforcement purposes. The agency now applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This becomes a new factor in trying to stay within FDA's legal corral.

Registration      Download Seminar Brochure
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  26th & 27th May, 2016
  • Washington, DC
  • 9:00 AM to 6:00 PM
  • Robert Elliott

The Magic of Conflict

This high-energy, interactive program offers a new definition of conflict, a new way of looking at it, a new way of experiencing it, and a new way of responding to it. You will learn to practice conflict resolution through the use of film clips,

Registration      Download Seminar Brochure
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  26th & 27th May, 2016
  • Washington, DC
  • 9 AM to 6 PM
  • Virginia A. Lang

The Integration of Human Factors into Design Controls and Risk Analysis

Human Factors/Usability testing is now a requirement. Human Factors/Usability testing is good business and can be easily integrated into product design/development. Human Factors is at the essence of the UseFMEA and hence instrumental in being able to reduce the probability of risk, and even the severity of risk.

Registration      Download Seminar Brochure
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  2nd & 3rd June, 2016
  • SFO, 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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  9th & 10th June, 2016
  • Las Vegas, CA
  • 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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  16th & 17th June, 2016
  • San Diego, CA
  • 9 AM to 6 PM
  • Casper Uldriks

FDA Device Software Regulation

Software's level of complexity and use is expanding at exponential levels. Likewise the potential risks to health follow suit. Problems with software create a number of different hurdles.

Registration      Download Seminar Brochure
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  June 30th & July 1st,   2016
  • New Orleans, LA
  • 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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  June 30th & July 1st, 2016
  • New Orleans, LA
  • 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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  7th & 8th July, 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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  21st & 22nd July, 2016
  • Chicago, IL
  • 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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  21st & 22nd July, 2016
  • Chicago, IL
  • 9:00 AM to 6:00 PM
  • Casper Uldriks

Marketing Products Without Getting Hammered by FDA

With this seminar you will learn how to navigate FDA's legal requirements and its interpretations for enforcement purposes. The agency now applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This becomes a new factor in trying to stay within FDA's legal corral.

Registration      Download Seminar Brochure
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  28th & 29th July, 2016
  • Los Angeles, CA
  • 9 AM to 6 PM
  • Dayna J. Reum

Payroll Fundamentals

This will be a all inclusive class that give details on understanding the laws such as FLSA and other laws such as the portal to portal act that help payroll professionals determine proper pay methods.

Registration      Download Seminar Brochure
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  18th & 19th August, 2016
  • SFO, CA
  • 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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  18th & 19th August, 2016
  • SFO, CA
  • 9 AM to 6 PM
  • Virginia A. Lang

The Integration of Human Factors into Design Controls and Risk Analysis

Human Factors/Usability testing is now a requirement. Human Factors/Usability testing is good business and can be easily integrated into product design/development. Human Factors is at the essence of the UseFMEA and hence instrumental in being able to reduce the probability of risk, and even the severity of risk.

Registration      Download Seminar Brochure
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  18th & 19th August, 2016
  • SFO, CA
  • 9:00 AM to 6:00 PM
  • Robert Elliott

The Magic of Conflict

This high-energy, interactive program offers a new definition of conflict, a new way of looking at it, a new way of experiencing it, and a new way of responding to it. You will learn to practice conflict resolution through the use of film clips,

Registration      Download Seminar Brochure
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  25th & 26th August, 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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  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
  • 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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  22nd & 23rd September, 2016
  • Seattle, WA
  • 9 AM to 6 PM
  • David R Dills

How to Prepare and Submit a 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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  13th & 14th October, 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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  20th & 21st October, 2016
  • San Diego, CA
  • 9 AM to 6 PM
  • David R Dills

Surviving an FDA Inspection: Understand the Do's and Don'ts and the Ground Rules

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

How to Prepare and Submit a 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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  8th & 9th December, 2016
  • Boston, MA
  • 9 AM to 6 PM
  • David R Dills

Surviving an FDA Inspection: Understand the Do's and Don'ts and the Ground Rules

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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