Upcoming Seminars

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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.

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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.

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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.

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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

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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.

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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,

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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.

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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.

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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.

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20th & 21st August, 2018
  • Boston, MA
  • 8:30 AM to 4:30 PM
  • Alfred A. Bartolucci

Examination of Laboratory, Medical and Device issues including Performance, Risk 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.

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23rd & 24th August, 2018
  • Philadelphia, PA
  • 9 AM to 6 PM
  • Angela Bazigos

Data Integrity: Learn to Comply with the FDA Expectations and Avoid Facing Penalties ranging from Public Warning Letters to Criminal Charges and Product Removal from the Market Place

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.

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23rd & 24th August, 2018
  • Philadelphia, PA
  • 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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28th & 29th August, 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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30th & 31st August, 2018
  • New Orleans, LA
  • 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.

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30th & 31st August, 2018
  • New Orleans, LA
  • 9:00 AM to 6:00 PM
  • Howard Baumgarten

The Next Level of Private Practice - Risk, Referrals, Retention & Resilience

The Next Level of Private Practice journeys into practice development expert Howard Baumgarten's trademark "four R's." These R's include Risk, Referrals, Retention, and Resilience. Each of these four areas possesses specific meaning to the practice owner; meaning that is both general as well as highly specialized and unique to each healthcare practice.

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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,

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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.

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20th & 21st September, 2018
  • San Diego, CA
  • 9:00 AM to 6:00 PM
  • Angela Bazigos

Hosting FDA Regulatory Inspections

The course will go through what typically goes on during an FDA inspection and will then cover how to prepare for, host and follow up to a regulatory inspection. It will focus the things that you should do or not do during the inspection. Typically FDA inspections can be highly structured and there are usually procedures that are to be followed.

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24th & 25th September, 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.

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26th & 27th September, 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.

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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.

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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.

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25th & 26th October, 2018
  • Seattle, WA
  • 9:00 AM to 6:00 PM
  • Howard Baumgarten

The Next Level of Private Practice - Risk, Referrals, Retention & Resilience

The Next Level of Private Practice journeys into practice development expert Howard Baumgarten's trademark "four R's." These R's include Risk, Referrals, Retention, and Resilience. Each of these four areas possesses specific meaning to the practice owner; meaning that is both general as well as highly specialized and unique to each healthcare practice.

Registration      Download Seminar Brochure
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25th & 26th October, 2018
  • Philadelphia, PA
  • 9:00 AM to 6:00 PM
  • Rita Hoffman

Uncovering and Managing Successful Post Market Compliance for Medical Devices

Customer satisfaction plays a significant role in measuring a product's postmarket performance. It is an indicator of how effective the product performance is managed. Both the quality system regulation (QSR) and the International Organization for Standardization (ISO) require procedures and processes to monitor and control your post market problems.

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29th & 30th October, 2018
  • Salt Lake City, UT
  • 9:00 AM to 6:00 PM
  • Paul R. Hales, J.D.

HIPAA 2018 - Staying Competitive and Complying with HIPAA

In today's competitive business climate, health care organizations and their business associates should be able to focus on growing their businesses and not worrying about HIPAA Compliance. Staying up to date on the newest health care information and acquiring new patients takes time.

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29th & 30th November, 2018
  • Zurich, Switzerland
  • 9:00 AM to 5:00 PM
  • David R. Dills

CE Mark Certification: Compile a CE Marking Technical File (or Design Dossier for Class III) containing evidence of compliance to the Medical Devices Directive (or the IVD/AIMD Directives) - Impact of the MDR for Europe

Introductions and Overview of the EU Directives Identify the EU Directives and standards applicable to your product Comply with the implementation details and requirements of the EU MDR & IVDR

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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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