Upcoming Seminars

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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.

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15th & 16th October, 2018
  • Salt Lake City, UT
  • 9:00 AM to 6:00 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.

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18th & 19th October, 2018
  • Washington, DC
  • 9:00 AM to 6:00 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.

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18th & 19th October, 2018
  • Washington, DC
  • 9:00 AM to 6:00 PM
  • Jeff Kasoff

Complaint and Recall Management: A Compliant, Lean Program

Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable,

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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.

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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.

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