Upcoming Seminars


img
  24th & 25th August, 2017
  • Cincinnati, OH
  • 9:00 AM to 4:30 PM
  • Ricardo Valls

Lineament analysis and appropriate sampling and Quality Assurance/Quality Control (QA/QC) procedures to help you find your next mine

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
img
  24th & 25th August, 2017
  • Tampa, FL
  • 9 AM to 6 PM
  • Paul Hales

HIPAA 2017 Under Trump - What to expect and How to comply

The secret is - HIPAA Rules are easy and routine to follow - when they are explained step-by-step in plain language. In this seminar Paul Hales will capture your attention with visual presentations, discussion and learning exercises and show how to find the right rule with the step-by-step procedures you need when you need them.

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

European Regulatory Affairs Process with EMA and other Regulatory Authorities

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
img
  August 31st & September 1st, 2017
  • Minneapolis, MN
  • 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
  August 31st & September 1st, 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
img
  7th & 8th September, 2017
  • SFO, CA
  • 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
  7th & 8th, September 2017
  • Washington, DC
  • 9:00 AM to 3:30 PM
  • Keith Warwick

Safety Management and OSHA Compliance

Development of a safety program to save costs, delayed schedules and the human cost of injury or death. Safety management guidelines and techniques for the engineering, construction, and scientific professions. Includes costs of preparing the necessary safety documentation.

Registration      Download Seminar Brochure
img
  11th & 12th September, 2017
  • Sydney, Australia
  • 9 AM to 6 PM
  • Teri C. Soli

The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems

This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems.

Registration      Download Seminar Brochure
img
  14th & 15th September, 2017
  • Shanghai, China
  • 9 AM to 6 PM
  • Teri C. Soli

The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems

This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems.

Registration      Download Seminar Brochure
img
  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
img
  28th & 29th September, 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
img
  28th & 29th September, 2017
  • Las Vegas, NV
  • 9:00 AM to 6:00 PM
  • Heath Rushing

Design of Experiments (DOE) for Process Development and Validation

Prior to developing a process control plan as part of an overall risk management strategy, process development studies must be completed. The objective of these process development studies is to gain knowledge and understanding about how variation in process parameters explains variation in the product quality characteristics of the product.

Registration      Download Seminar Brochure
img
  28th & 29th September 2017
  • Boston, MA
  • 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
img
  12th & 13th October, 2017
  • Cincinnati, OH
  • 9 AM to 6 PM
  • Jay Hodes

HIPAA Compliance Requirements for Business Associates

As defined by the Health Information Portability and Accountability Act (HIPAA), a Business Associate can be any organization or person working in association with or providing services to a Covered Entity who handles or discloses Protected Health Information (PHI) or Personal Health Records (PHR).

Registration      Download Seminar Brochure
img
  12th & 13th October, 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
  12th & 13th October, 2017
  • Los Angeles, CA
  • 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
  12th & 13th October, 2017
  • Washington, DC
  • 9 AM to 6 PM
  • Brian Shoemaker

Documenting Software for FDA Submissions

When medical device companies consider Agile development methods, they often run into the key criticism that Agile groups produce little to no documentation, and that Agile stands in contradiction to the lifecycle standards outlined in IEC 62304.

Registration      Download Seminar Brochure
img
  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
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
  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
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
  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
  • Chicago, IL
  • 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
  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
Copyright © 2017 GlobalCompliancePanel. All rights reserved. Netzealous