Upcoming Seminars


img
  16th & 17th October, 2017
  • Singapore
  • 9:00 AM to 6:00 PM
  • David R. Dills

Japan - Regulatory Filing Requirements and Compliance Processes for Medical Devices

Japan's classification system differs from that of the United States or European Union, Medical devices are classified to Class I, II, III, or IV depending on their risk level, Medical devices must also comply with Japanese Industrial Standards and these standards define industry-wide safety and performance requirements

Registration      Download Seminar Brochure
img
  19th & 20th October, 2017
  • San Diego, CA
  • 9 AM to 6 PM
  • David R. Dills

Complaint-Handling, MDR and Recall Management

An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.

Registration      Download Seminar Brochure
img
  26th & 27th October, 2017
  • San Diego, CA
  • 9:00 AM to 6:00 PM
  • Susanne Manz

Compliance Boot Camp

This 2-day seminar will cover the essentials of compliance for medical device companies. An efficient and effective quality system can be a competitive advantage for companies by leading to improved quality and compliance as well as optimizing the cost of quality.

Registration      Download Seminar Brochure
img
  26th & 27th October, 2017
  • San Diego, CA
  • 9:00 AM to 6:00 PM
  • Dan O'Leary

Complaints, Adverse Event Reporting, and Recalls - An Integrated Approach

Medical Device manufacturers operate in numerous regulatory systems that often have different requirements and are not always consistent. The new ISO 13485:2016 emphasizes this problem. Manufacturers must identify their roles, identify the regulatory requirements for that role, and incorporate them into the quality management system.

Registration      Download Seminar Brochure
img
  2nd & 3rd November, 2017
  • 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

Registration      Download Seminar Brochure
img
  2nd & 3rd November, 2017
  • Baltimore, MD
  • 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.

Registration      Download Seminar Brochure
img
  9th & 10th November, 2017
  • Los Angeles, CA
  • 9:00 AM to 6:00 PM
  • Steven Walfish

Statistics for the Non-Statistician

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. Statistics of course, requires constant practice.

Registration      Download Seminar Brochure
img
  9th & 10th November, 2017
  • Seoul, South Korea
  • 9 AM to 6 PM
  • Dr. Steven Kuwahara

GMP and Regulatory Expectations for Early IND Products

This course will present, in one place, the regulations and guidelines that apply to early phase products. In some cases these will not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process.

Registration      Download Seminar Brochure
img
  9th & 10th November, 2017
  • Salt Lake City, UT
  • 9 AM to 6 PM
  • James Wisnowski

Statistical Methods: A Visual Approach

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?

Registration      Download Seminar Brochure
img
  13th & 14th November, 2017
  • Taipei, Taiwan
  • 9 AM to 6 PM
  • Dr. Steven Kuwahara

GMP and Regulatory Expectations for Early IND Products

This course will present, in one place, the regulations and guidelines that apply to early phase products. In some cases these will not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process.

Registration      Download Seminar Brochure
img
  16th & 17th November, 2017
  • 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
img
  16th & 17th November, 2017
  • Boston, MA
  • 9:00 AM to 6:00 PM
  • Susanne Manz

Compliance Boot Camp

This 2-day seminar will cover the essentials of compliance for medical device companies. An efficient and effective quality system can be a competitive advantage for companies by leading to improved quality and compliance as well as optimizing the cost of quality.

Registration      Download Seminar Brochure
img
  16th & 17th November, 2017
  • Boston, MA
  • 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.

Registration      Download Seminar Brochure
img
  November 30th & December 1st, 2017
  • Chicago, IL
  • 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
img
  November 30th & December 1st, 2017
  • Washington, DC
  • 9 AM to 6 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
img
  November 30th & December 1st, 2017
  • Chicago, IL
  • 9 AM to 6 PM
  • Jim Sheldon-Dean

HIPAA Privacy, Security and Breach Notification Compliance: Understanding the Requirements, Preventing Incidents, Surviving Audits, and Avoiding Penalties

This session is designed to provide intensive, two-day training in HIPAA compliance, including what's new in the regulations, what's changed recently, and what needs to be addressed for compliance by covered entities and business associates.

Registration      Download Seminar Brochure
img
  4th & 5th, December 2017
  • 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,

Registration      Download Seminar Brochure
img
  7th & 8th December, 2017
  • Boston, MA
  • 8:30 AM to 4:30 PM
  • Ronald L. Adler

Incorporating Risk Management into Your HR Policy

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, risk management, internal auditing, and human resource management issues.

Registration      Download Seminar Brochure
img
  7th & 8th December, 2017
  • Orlando, FL
  • 9:00 AM to 6:00 PM
  • Brian L Tuttle

Why you Should be Worried about HIPAA

This seminar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits or (even worse) litigation occurs against your organization under state laws of negligence.

Registration      Download Seminar Brochure
img
  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.

Registration      Download Seminar Brochure
img
  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.

Registration      Download Seminar Brochure
img
  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.

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

Tougher Import Rules for FDA Imports in 2017

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

Tougher Import Rules for FDA Imports in 2017

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
img
  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
img
  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
img
  11th & 12th July, 2018
  • Singapore
  • 9:00 AM to 6:00 PM
  • Casper Uldriks

Tougher Import Rules for FDA Imports in 2017

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
img
  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
img
  6th & 7th December, 2018
  • Raleigh, NC
  • 9:00 AM to 6:00 PM
  • Casper Uldriks

Tougher Import Rules for FDA Imports in 2017

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
Copyright © 2017 GlobalCompliancePanel. All rights reserved. Netzealous