Upcoming Seminars


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  21st & 22nd May, 2018
  • Boston, MA
  • 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.

Registration      Download Seminar Brochure
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  4th & 5th June, 2018
  • Seattle, WA
  • 9:00 AM to 6:00 PM
  • Michael Esposito

Learning Management Systems (LMS)

This course will describe the development of job position curricula in the pharmaceutical industry using a Learning Management System (LMS) and provide you with the tools needed to create effective curricula.

Registration      Download Seminar Brochure
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  June 5th, 2018
  • Savannah, GA
  • 9 AM to 6 PM
  • Brian L Tuttle

HIPAA and the Business Associate

This one-day seminar will be addressing how a business associate needs to comply with HIPAA and when it applies The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information regarding the do's and don'ts with HIPAA - I want to add clarity for business associates and also help businesses comply,

Registration      Download Seminar Brochure
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  6th & 7th June, 2018
  • Washington, DC
  • 9:00 AM to 5:00 PM
  • David 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

Senior management takes responsibility for quality and GXP compliance. It is not something delegated to the quality unit or to the regulatory affairs group. Developing and implementing an effective inspection readiness plan will help ensure better results, as well as a less stressful Inspection.

Registration      Download Seminar Brochure
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  7th & 8th June, 2018
  • Washington, DC
  • 9:00 AM to 6:00 PM
  • Teri C. Soli

The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems for Bio-pharma, Medical Devices and Cosmetics Industries

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
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  11th & 12th June, 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
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  12th & 13th June, 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

Registration      Download Seminar Brochure
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  13th & 14th June, 2018
  • Salt Lake City, UT
  • 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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  21st & 22nd June, 2018
  • Chicago, IL
  • 9:00 AM to 6:00 PM
  • Angela Bazigos

Writing & Managing Effective SOPs

Every biopharmaceutical company has SOPs, and new staff members are told that the company "has to have them" and that each employee "has to follow them". But why do there have to be SOPs and why must we follow them as written? And how can we do this effectively?

Registration      Download Seminar Brochure
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  25th & 26th June, 2018
  • Chicago, IL
  • 9 AM to 6 PM
  • Salma Michor

Combination Products

Combination products are especially challenging to register and maintain since they consist of two or more regulated components covered by different and usually independent sets of regulations in both the EU and US and various other regions.

Registration      Download Seminar Brochure
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  25th & 26th June, 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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  25th & 26th June, 2018
  • Boston, MA
  • 9 AM to 6 PM
  • Carolyn Troiano

FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

FDA requires that all computer systems used to produce, manage and report on "GxP" (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This seminar will help you understand the FDA's current thinking on computer systems that are validated and subject to inspection and audit.

Registration      Download Seminar Brochure
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  27th & 28th June, 2018
  • Chicago, IL
  • 9 AM to 6 PM
  • Salma Michor

The New EU Medical Device regulation

In 2012, the Commission adopted a package of measures on innovation in health. The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices.

Registration      Download Seminar Brochure
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  10th & 11th July, 2018
  • Washington, DC
  • 9:00 AM to 6:00 PM
  • Elaine Eisenbeisz

Statistics for Process and Quality Control

This 2-day seminar includes the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products. The concepts and information presented will be mainly concerned with statistical quality control: obtaining information (data) that is objective,

Registration      Download Seminar Brochure
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  10th & 11th July, 2018
  • Washington, DC
  • 8:00 AM to 5:00 PM
  • Michael Aust

OSHA 10 Hour General Industry Course

Outreach training content includes hazard recognition and avoidance, workers' rights, employer responsibilities, and how to file a complaint; it emphasizes the value of safety and health to workers, including young workers.

Registration      Download Seminar Brochure
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  11th & 12th July, 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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  16th & 17th July, 2018
  • Boston, MA
  • 9 AM to 6 PM
  • Eleonora Babayants

GxP/GMP and its Consequences for Quality Management, Quality Audit, Documentation, and Information Technology Systems

GxP/GMP regulations are required to be used in regulated industries such as food and beverages, pharmaceutical, medical devices, and cosmetics. GMP regulations describe required quality management system for production and testing of products in these regulated industries.

Registration      Download Seminar Brochure
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  18th & 19th July, 2018
  • Philadelphia, PA
  • 9 AM to 5 PM
  • Jim Sheldon-Dean

Master Class for the HIPAA Officer: Protecting Patient Information and Implementing Today's Privacy, Security, and Breach Regulations

Day one begins 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,

Registration      Download Seminar Brochure
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  July 19th & 20th, 2018
  • Philadelphia, PA
  • 9:00 AM to 6:00 PM
  • Markus Weber

Software Risk Management

The seminar will address the specific challenges software poses for the risk management process. Basic risk management concepts will be introduced and then applied to software specific applications.

Registration      Download Seminar Brochure
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  24th & 25th July, 2018
  • Chicago, IL
  • 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.

Registration      Download Seminar Brochure
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  26th & 27th July, 2018
  • Chicago, IL
  • 9:00 AM to 6:00 PM
  • Dan O'Leary

Production and Process Control: Building a Robust System

A medical device production system must be efficient, effective, and compliant. This includes the right controls – documented instructions, environmental control, adequate equipment properly installed and maintained, production software, properly controlled test equipment, and validated processes.

Registration      Download Seminar Brochure
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  26th & 27th July, 2018
  • Boston, MA
  • 9:00 AM to 6:00 PM
  • Angela Bazigos

Clinical Data Management

When new drugs or devices are tested in humans, the data generated by, and related to, these trials is known as clinical data. This data represents a huge investment by the biopharmaceutical or device company and is one of its greatest assets. It is this data that will eventually make a new product both useful as a treatment or therapy and marketable.

Registration      Download Seminar Brochure
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  30th & 31st July, 2018
  • New Orleans, LA
  • 9:00 AM to 6:00 PM
  • Natasha Tracy

Living with Depression - Unveiled

Mental illness is something that can take a dramatic toll on a person and all those around him. Impacts from mental illness are seen in one's home, work and personal life. Serious mental illnesses like major depressive disorder can even lead to the death of those suffering from them. Mental illness is not something to be taken lightly.

Registration      Download Seminar Brochure
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  July 31st, 2018
  • New Orleans, LA
  • 9 AM to 6 PM
  • Brian L Tuttle

Responsibilities of a HIPAA Security Officer

This one-day seminar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information all over regarding the do's and don'ts with HIPAA - I want to add clarity for compliance officers

Registration      Download Seminar Brochure
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  2nd & 3rd August, 2018
  • San Diego, CA
  • 9:00 AM to 6:00 PM
  • Jim Wisnowski

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
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  7th & 8th August, 2018
  • Berlin, Germany
  • 9:00 AM to 6:00 PM
  • Stefan Menzl

European Medical Device Regulation / key changes overview

Europe's new Medical Devices Regulation 2017/745 (MDR) takes effect in May-2020. That seems like plenty of time, but smart companies should start planning their CE transition strategy right away. With manufacturers all over the world transitioning to the MDR and ISO 13485:2016 in the next few years,

Registration      Download Seminar Brochure
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  August 15th, 2018
  • Raleigh, NC
  • 9 AM to 6 PM
  • Brian L Tuttle

HIPAA Training for the Practice Manager

This one-day seminar will be addressing how medical practice 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 2018.

Registration      Download Seminar Brochure
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  16th & 17th August, 2018
  • Baltimore, MD
  • 9 AM to 6 PM
  • John Ryan

Prepare Your Company to Comply with the New FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods

Transportation and Logistics food transportation food safety rules have been finalized by the U.S. Food and Drug Administration (FDA). Under congressional instructions, the Food Safety Modernization Act (FSMA) requires the FDA to establish rules to improve, audit and enforce new food safety transportation rules.

Registration      Download Seminar Brochure
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  20th & 21st August, 2018
  • Boston, MA
  • 9:00 AM to 6:00 PM
  • Susanne Manz

Strategies for Improving Effectiveness and Efficiency of your Quality Management System

This 2-day seminar will cover the essentials of an effective yet efficient quality management system 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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  13th & 14th September, 2018
  • Boston, MA
  • 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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  18th & 19th September, 2018
  • San Diego, CA
  • 9:00 AM to 6:00 PM
  • Elaine Eisenbeisz

Statistics for Process and Quality Control

This 2-day seminar includes the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products. The concepts and information presented will be mainly concerned with statistical quality control: obtaining information (data) that is objective,

Registration      Download Seminar Brochure
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  18th & 19th September, 2018
  • San Diego, CA
  • 9:00 AM to 6:00 PM
  • Natasha Tracy

Living with Depression - Unveiled

Mental illness is something that can take a dramatic toll on a person and all those around him. Impacts from mental illness are seen in one's home, work and personal life. Serious mental illnesses like major depressive disorder can even lead to the death of those suffering from them. Mental illness is not something to be taken lightly.

Registration      Download Seminar Brochure
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  18th & 19th September, 2018
  • San Diego, CA
  • 8:00 AM to 5:00 PM
  • Michael Aust

OSHA 10 Hour General Industry Course

Outreach training content includes hazard recognition and avoidance, workers' rights, employer responsibilities, and how to file a complaint; it emphasizes the value of safety and health to workers, including young workers.

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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  15th & 16th October, 2018
  • Salt Lake city, UT
  • 9:00 AM to 6:00 PM
  • Susanne Manz

Strategies for Improving Effectiveness and Efficiency of your Quality Management System

This 2-day seminar will cover the essentials of an effective yet efficient quality management system 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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  22nd & 23rd October, 2018
  • Washington, DC
  • 9:00 AM to 6:00 PM
  • Michael Esposito

Learning Management Systems (LMS)

This course will describe the development of job position curricula in the pharmaceutical industry using a Learning Management System (LMS) and provide you with the tools needed to create effective curricula.

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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