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Upcoming Seminars


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  23rd & 24th March, 2017
  • Washington, DC
  • 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
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  23rd & 24th March 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
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  23th & 24th March, 2017
  • San Diego, CA
  • 9 AM to 6 PM
  • Brian L Tuttle

HIPAA Survival - All you need to Know

This seminar 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 2017.

Registration      Download Seminar Brochure
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  23rd & 24th March, 2017
  • Washington, DC
  • 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
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  30th & 31st March, 2017
  • Los Angeles, CA
  • 9 AM to 6 PM
  • Jim Wener

2017 HIPAA Compliance

This two day seminar takes the participants through HIPAA compliance from start to compliance. The presentations explain 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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  30th & 31st March, 2017
  • Los Angeles, CA
  • 9 AM to 6 PM
  • Vanessa G. Nelson

Roadmap to Advanced Human Resources and Employment Law

Are You Prepared for the New Presidential Administration? Is your company at risk for non-compliance? Is your company a lawsuit waiting to happen? 2017 comes in with a lot of uncertainties. With a new administration in the white house, employers can expect drastic change, which may affect and impact your organization. Additionally, employment lawsuits are on the rise.

Registration      Download Seminar Brochure
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  6th & 7th April, 2017
  • Baltimore, MD
  • 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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  6th & 7th April, 2017
  • Baltimore, MD
  • 9 AM to 6 PM
  • David R Dills

Why is FDA at my facility, and what do I do during an inspection

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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  13th & 14th April, 2017
  • Salt Lake City, UT
  • 9 AM to 6 PM
  • Brian L Tuttle

HIPAA 2017

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.

Registration      Download Seminar Brochure
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  13th & 14th April, 2017
  • Salt Lake City, UT
  • 9:00 AM to 6:00 PM
  • John Fetzer

Writing and implementing effective SOP's

An SOP is a meticulous step-by-step description of how to do a task that leave no chance for errors and divergence. Writing a good SOP is not an easy job. It requires a firm understanding of the task to be described, an ability to describe in specific unique to that laboratory.

Registration      Download Seminar Brochure
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  20th & 21st April, 2017
  • San Diego, CA
  • 8:30 AM to 5:30 PM
  • Thomas E. Colonna

Overview of Device Regulation - FDA

This course provides a basic description of an FDA regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development. It offers guidelines for developing successful strategies for medical devices,

Registration      Download Seminar Brochure
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  27th & 28th April, 2017
  • Raleigh, NC
  • 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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  27th & 28th April, 2017
  • Raleigh, NC
  • 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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  4th & 5th May, 2017
  • Boston, MA
  • 9 AM to 6 PM
  • Jim Wener

2017 HIPAA Compliance

This two day seminar takes the participants through HIPAA compliance from start to compliance. The presentations explain 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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  4th & 5th May, 2017
  • Las Vegas, NV
  • 9 AM to 5 PM
  • Jim Sheldon Dean

Modern HIPAA Compliance - Managing Privacy, Security, and Breach Notification in a World of New Technologies, New Threats, and New Rules

Day one sets the stage with an overview of the HIPAA regulations including HIPAA Breach Notification and the process that must be used to determine whether or not a breach is reportable, and then continues with presentation of the specifics of the Privacy Rule, recent changes to the rules, and the basics of the Security Rule.

Registration      Download Seminar Brochure
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  4th & 5th May, 2017
  • Boston, MA
  • 8:30 AM to 4:30 PM
  • Alfred Bartolucci

Laboratory, Medical and Device Performance and Validation following Regulatory and ICH Statistical Guidelines

This course is designed to introduce to individuals the understanding and interpretation of the statistical concepts one uses when investigating quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits, and process and quality control.

Registration      Download Seminar Brochure
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  11th & 12th May, 2017
  • Los Angeles, CA
  • 9:00 AM to 6:00 PM
  • Virginia A Lang

Human Factors and Predicate Combination Products

The FDA has placed significant emphasis on the role of Human Factors in the approval of devices used for medical purposes. There are several current guidance documents and new proposed Draft Guidance documents. This seminar will compare these Guidance documents.

Registration      Download Seminar Brochure
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  18th & 19th May, 2017
  • Chicago, IL
  • 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
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  18th & 19th May, 2017
  • Chicago, IL
  • 9 AM to 6 PM
  • Vanessa G. Nelson

Roadmap to Advanced Human Resources and Employment Law

Are You Prepared for the New Presidential Administration? Is your company at risk for non-compliance? Is your company a lawsuit waiting to happen? 2017 comes in with a lot of uncertainties. With a new administration in the white house, employers can expect drastic change, which may affect and impact your organization. Additionally, employment lawsuits are on the rise.

Registration      Download Seminar Brochure
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  18th & 19th May, 2017
  • Chicago, IL
  • 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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  25th & 26th May, 2017
  • Philadelphia, PA
  • 9:00 AM to 6:00 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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  25th & 26th May, 2017
  • Philadelphia, PA
  • 9 AM to 4 PM
  • Jeff Kasoff

Supplier Management in FDA- and ISO-regulated Industry

Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance. Many companies can spend significantly less time and money, and still be in control of their suppliers and in compliance with the regulations.

Registration      Download Seminar Brochure
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  8th & 9th June, 2017
  • Baltimore, MD
  • 9:00 AM to 6:00 PM
  • John Fetzer

Writing and implementing effective SOP's

An SOP is a meticulous step-by-step description of how to do a task that leave no chance for errors and divergence. Writing a good SOP is not an easy job. It requires a firm understanding of the task to be described, an ability to describe in specific unique to that laboratory.

Registration      Download Seminar Brochure
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  15th & 16th June, 2017
  • Salt Lake City, UT
  • 8:30 AM to 4:30 PM
  • Alfred Bartolucci

Laboratory, Medical and Device Performance and Validation following Regulatory and ICH Statistical Guidelines

This course is designed to introduce to individuals the understanding and interpretation of the statistical concepts one uses when investigating quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits, and process and quality control.

Registration      Download Seminar Brochure
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  15th & 16th June, 2017
  • Zurich, Switzerland
  • 9:00 AM to 6:00 PM
  • David R. Dills

Good Clinical Practices (GCP) - Understanding and Implementing the Current Global Requirements

Defining the basic requirements of Good Clinical Practices, Clinical Study Protocol Elements and Device Accountability, Role of Institutional Review Board (IRB) and Informed Consent, Principles of Ethics and Quality Control Determining the appropriate duties and oversight required of the sponsor, monitor, and investigators to ensure a high level of quality in a clinical trial

Registration      Download Seminar Brochure
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  19th & 20th June, 2017
  • Singapore
  • 9:00 AM to 6:00 PM
  • David R. Dills

Good Clinical Practices (GCP) - Understanding and Implementing the Current Global Requirements

Defining the basic requirements of Good Clinical Practices, Clinical Study Protocol Elements and Device Accountability, Role of Institutional Review Board (IRB) and Informed Consent, Principles of Ethics and Quality Control Determining the appropriate duties and oversight required of the sponsor, monitor, and investigators to ensure a high level of quality in a clinical trial

Registration      Download Seminar Brochure
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  22nd & 23rd June, 2017
  • Boston, MA
  • 8:30 AM to 5:30 PM
  • Thomas E. Colonna

Overview of Device Regulation - FDA

This course provides a basic description of an FDA regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development. It offers guidelines for developing successful strategies for medical devices,

Registration      Download Seminar Brochure
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  20th & 21st July, 2017
  • Washington DC
  • 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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  20th & 21st July, 2017
  • Washington, DC
  • 9:00 AM to 6:00 PM
  • Virginia A Lang

Human Factors and Predicate Combination Products

The FDA has placed significant emphasis on the role of Human Factors in the approval of devices used for medical purposes. There are several current guidance documents and new proposed Draft Guidance documents. This seminar will compare these Guidance documents.

Registration      Download Seminar Brochure
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  20th & 21st July, 2017
  • Boston, MA
  • 9:00 AM to 6:00 PM
  • Steven Walfish

Statistics for Non-Statisticians

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
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  27th & 28th July, 2017
  • Miami, FL
  • 8:30 AM to 4:30 PM
  • Alfred Bartolucci

Laboratory, Medical and Device Performance and Validation following Regulatory and ICH Statistical Guidelines

This course is designed to introduce to individuals the understanding and interpretation of the statistical concepts one uses when investigating quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits, and process and quality control.

Registration      Download Seminar Brochure
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  27th & 28th July, 2017
  • Washington, DC
  • 9 AM to 5 PM
  • Jim Sheldon Dean

Modern HIPAA Compliance - Managing Privacy, Security, and Breach Notification in a World of New Technologies, New Threats, and New Rules

Day one sets the stage with an overview of the HIPAA regulations including HIPAA Breach Notification and the process that must be used to determine whether or not a breach is reportable, and then continues with presentation of the specifics of the Privacy Rule, recent changes to the rules, and the basics of the Security Rule.

Registration      Download Seminar Brochure
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  27th & 28th July, 2017
  • Philadelphia, PA
  • 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
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  27th & 28th July, 2017
  • Philadelphia, PA
  • 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
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  27th & 28th July, 2017
  • Philadelphia, PA
  • 9:00 AM to 6:00 PM
  • David R. Dills

Effective Internal and External Quality Assurance Auditing for FDA Regulated Industry

Principles and Audit Planning, Planning and preparation, Internal audits are critical element of your quality management system. Your approach must be both systematic and documented to remain compliant, Information from an internal audit provides management with the knowledge they need to show how effectively the company maintains the quality of the product and their processes

Registration      Download Seminar Brochure
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  28th & 29th August, 2017
  • Zurich, Switzerland
  • 9:00 AM to 6:00 PM
  • David R. Dills

European Regulatory Procedures - Comprehensive Overview of EMA and National Requirements and other Agencies

EMA has a 20-year track record of ensuring efficacy and safety of human and veterinary medicines across Europe, and promoting research and innovation in the development of medicines. In its first two decades, the Agency recommended the authorization of a total of 975 human and 188 veterinary medicines.

Registration      Download Seminar Brochure
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  14th & 15th September, 2017
  • San Diego, CA
  • 9 AM to 4 PM
  • Jeff Kasoff

Supplier Management in FDA- and ISO-regulated Industry

Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance. Many companies can spend significantly less time and money, and still be in control of their suppliers and in compliance with the regulations.

Registration      Download Seminar Brochure
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  12th & 13th October, 2017
  • Zurich, Switzerland
  • 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
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  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
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  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
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  26th & 27th October, 2017
  • Los Angeles, CA
  • 9:00 AM to 6:00 PM
  • Steven Walfish

Statistics for Non-Statisticians

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
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  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
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  6th & 7th November, 2017
  • Singapore
  • 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
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