Upcoming Seminars


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  18th & 19th January, 2018
  • San Diego, CA
  • 9 AM to 6 PM
  • Brian Shoemaker

Medical Device Software: An Incremental Approach to Risk and Quality Management

Engineers are dedicated to making things work, so a focus on how they might fail and harm someone can seem alien. Managing risk, however, is essential for all medical products- medical devices, including those involving software, have produced some painful examples of poor risk management with serious consequences.

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  18th & 19th January, 2018
  • San Diego, CA
  • 9 AM to 6 PM
  • Angela Bazigos

A Risk Based Approach to Testing of Computerized GxP Systems

Testing is the science of identifying defects, so that they can be corrected, and of demonstrating that a system meets intended requirements. Testing computerized systems is considered a fundamental verification activity and appropriate testing is a regulatory expectation as described in many regulations e.g. EU GMP Annex 11.

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  18th & 19th January, 2018
  • San Diego, CA
  • 9:00 AM to 6:00 PM
  • Jim Wener

HIPAA Compliance 2018

This two day seminar takes the participants through HIPAA compliance from start to compliance. The first presentation explains the history of HIPAA, why it came to being and its evolution. This covers what HIPAA is, what steps have to be performed to be HIPAA compliant and what HIPAA compliance is.

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  25th & 26th January, 2018
  • Washington, DC
  • 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).

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  29th & 30th January, 2018
  • Detroit, MI
  • 9 AM to 6 PM
  • Steven Wachs

Predicting & Improving Product Reliability

Participants will gain awareness of the overall methodology for setting reliability targets, estimating product reliability from test data and/or field data, and determining whether or not reliability targets are achieved. Methods for estimating the reliability of subsystems and systems are also discussed.

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  29th & 30th January, 2018
  • Philadelphia, PA
  • 9 AM to 6 PM
  • Susanne Manz

Death by CAPA - Does your CAPA Program need a CAPA?

This 2-day seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance.

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  29th & 30th January, 2018
  • Philadelphia, PA
  • 9 AM to 6 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.

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  1st & 2nd February, 2018
  • Baltimore, MD
  • 9:00 AM to 6:00 PM
  • Stephanie Cooke
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  7th & 8th February, 2018
  • Zurich, Switzerland
  • 9:00 AM to 6:00 PM
  • David R. Dills

Medical Device Registration and Approval Process for the Pacific Rim (including India, Japan, China, Singapore, Australia, Taiwan, Hong Kong, and other locations)

Classification systems differ from that of the United States or European Union in select countries, Medical devices are classified depending on their risk level, Medical devices must also comply with additional country standards and these standards define industry-wide safety and performance requirements

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  12th & 13th, February 2018
  • Washington, DC
  • 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,

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  14th & 15th February, 2018
  • Houston, TX
  • 9:00 AM to 6:00 PM
  • John Zorich

Applied Statistics, with Emphasis on Verification, Validation, Sample Size, and Risk Management, in R&D, Manufacturing, and QA/QC

The 2-day seminar explains how to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows

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  15th & 16th February, 2018
  • Dallas, TX
  • 9:00 AM to 6:00 PM
  • Casper Uldriks

Tougher Import Rules for FDA Imports in 2018

What happens when your product is detained? FDA will begin a legal process that can become an expensive business debacle. You must respond fully within short timeframes. This is not the time for you to be on a learning curve. You need to have a plan in place and know what you are doing.

Registration      Download Seminar Brochure
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  15th & 16th February, 2018
  • Dallas, TX
  • 9:00 AM to 6:00 PM
  • Markus Weber

Risk Management in Medical Devices Industry

Gaps, incorrect or incomplete implementation of software can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle.

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  22nd & 23rd February, 2018
  • Los Angeles, CA
  • 9 AM to 6 PM
  • Angela Bazigos

A Risk Based Approach To Data Integrity

The impact of Data Integrity issues on a regulated company can be significant: it can result in recalls of products, warning or untitled letters, import alerts, injunctions, seizures, legal action, etc. These regulatory actions can have significant financial impact to the company.

Registration      Download Seminar Brochure
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  1st & 2nd March, 2018
  • Boston, MA
  • 9:00 AM to 6:00 PM
  • Stephanie Cooke

Different requirements for Phase I Investigational Drug Products: which GMPs apply since most Phase I drugs are exempt from full GMP requirements and what IND data requirements are necessary as a result?

In January 2006, FDA issued a final rule which specified that most pharmaceutical products (including biologics) produced for use in Phase I clinical trial studies were exempted from complying with GMP requirements, as defined in 21 CFR Part 211 under 21 CFR 210.2(c).

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  1th & 2th March, 2018
  • Boston, MA
  • 9:00 AM to 6:00 PM
  • Elaine Eisenbeisz

Biostatistics for the Non-Statistician

Statistics is a useful decision making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand the theory and application of statistics.

Registration      Download Seminar Brochure
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  8th & 9th March, 2018
  • New Orleans, LA
  • 9:00 AM to 6:00 PM
  • Jim Wener

HIPAA Compliance 2018

This two day seminar takes the participants through HIPAA compliance from start to compliance. The first presentation explains the history of HIPAA, why it came to being and its evolution. This covers what HIPAA is, what steps have to be performed to be HIPAA compliant and what HIPAA compliance is.

Registration      Download Seminar Brochure
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  29th & 30th March, 2018
  • Chicago, IL
  • 9:00 AM to 6:00 PM
  • Brian G. Nadel

FDA Penalties for Regulatory Non-Compliance in the Pharmaceuticals Industry - 2017 in Review

The FDA is increasing its enforcement actions both for domestic and foreign inspections. Enforcement statistics have not been summarized yet because 2017 has not ended yet. We are certainly seeing more Warning Letters and Import Alerts based on Data Integrity (21 CFR Part 11: Electronic Records; Electronic Signatures. In the past FDA used to issue several Warning Letters to the same firms upon consecutive inspections.

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  11th & 12th April, 2018
  • Zurich, Switzerland
  • 9:00 AM to 6:00 PM
  • Casper Uldriks

Tougher Import Rules for FDA Imports in 2018

What happens when your product is detained? FDA will begin a legal process that can become an expensive business debacle. You must respond fully within short timeframes. This is not the time for you to be on a learning curve. You need to have a plan in place and know what you are doing.

Registration      Download Seminar Brochure
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  19th & 20th April, 2018
  • Washington DC
  • 9 AM to 6 PM
  • Angela Bazigos

A Risk Based Approach To Data Integrity

The impact of Data Integrity issues on a regulated company can be significant: it can result in recalls of products, warning or untitled letters, import alerts, injunctions, seizures, legal action, etc. These regulatory actions can have significant financial impact to the company.

Registration      Download Seminar Brochure
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  26th & 27th April, 2018
  • Seattle, WA
  • 9:00 AM to 6:00 PM
  • Stephanie Cooke
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  10th & 11th May, 2018
  • Salt Lake City, UT
  • 9:00 AM to 6:00 PM
  • Stephanie Cooke

Different requirements for Phase I Investigational Drug Products: which GMPs apply since most Phase I drugs are exempt from full GMP requirements and what IND data requirements are necessary as a result?

In January 2006, FDA issued a final rule which specified that most pharmaceutical products (including biologics) produced for use in Phase I clinical trial studies were exempted from complying with GMP requirements, as defined in 21 CFR Part 211 under 21 CFR 210.2(c).

Registration      Download Seminar Brochure
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  10th & 11th May, 2018
  • Salt Lake city, UT
  • 9:00 AM to 6:00 PM
  • Elaine Eisenbeisz

Biostatistics for the Non-Statistician

Statistics is a useful decision making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand the theory and application of statistics.

Registration      Download Seminar Brochure
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  17th & 18th May, 2018
  • Philadelphia, PA
  • 9:00 AM to 4:30 PM
  • Casper Uldriks

FDA Scrutiny of Promotion and Advertising Practices

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.

Registration      Download Seminar Brochure
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  11th & 12th July, 2018
  • Singapore
  • 9:00 AM to 6:00 PM
  • Casper Uldriks

Tougher Import Rules for FDA Imports in 2018

What happens when your product is detained? FDA will begin a legal process that can become an expensive business debacle. You must respond fully within short timeframes. This is not the time for you to be on a learning curve. You need to have a plan in place and know what you are doing.

Registration      Download Seminar Brochure
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  11th & 12th October, 2018
  • SFO, CA
  • 9:00 AM to 4:30 PM
  • Casper Uldriks

FDA Scrutiny of Promotion and Advertising Practices

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.

Registration      Download Seminar Brochure
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  6th & 7th December, 2018
  • Raleigh, NC
  • 9:00 AM to 6:00 PM
  • Casper Uldriks

Tougher Import Rules for FDA Imports in 2018

What happens when your product is detained? FDA will begin a legal process that can become an expensive business debacle. You must respond fully within short timeframes. This is not the time for you to be on a learning curve. You need to have a plan in place and know what you are doing.

Registration      Download Seminar Brochure
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