Training and Teaching

Listings
  • Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals 2017

    Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals 2017

    Training and Teaching Raleigh, NC (Raleigh, NC) February 24, 2017 1295.00 Dollar US$

    Overview: This workshop style training course is designed based on 30 year of regulatory affairs experience in preparing more than 150 successful U.S. FDA submissions for major medical device companies. In these 2 days, the following essential elemen...

  • Implementing ISO 13485:2016- 2017 by Dan O'Leary

    Implementing ISO 13485:2016- 2017 by Dan O'Leary

    Training and Teaching Raleigh, NC ( Raleigh, NC) February 24, 2017 1295.00 Dollar US$

    Overview: 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)...

  • Overview of Device Regulation – FDA 2017

    Overview of Device Regulation – FDA 2017

    Training and Teaching San Diego, CA (San Diego, CA) February 24, 2017 1295.00 Dollar US$

    Overview: 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 med...

  • Common Frauds: Creating and Improving Anti-Fraud Controls for Businesses 2017

    Common Frauds: Creating and Improving Anti-Fraud Controls for Businesses 2017

    Training and Teaching San Diego, CA (San Diego, CA) February 24, 2017 1295.00 Dollar US$

    Overview: This course will address the risks to a business from data breaches, various forms of cyberfraud and identity theft. We will discuss the legal issues with data breaches including issues for companies that are victims of data breaches. We wi...

  • Applied Statistics for FDA Process Validation 2017

    Applied Statistics for FDA Process Validation 2017

    Training and Teaching San Diego, CA (San Diego, CA) February 24, 2017 1295.00 Dollar US$

    Course "Applied Statistics for FDA Process Validation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: In Guidance for Industry Process Validation: General Pri...

  • Writing and implementing effective SOP's 2017

    Writing and implementing effective SOP's 2017

    Training and Teaching Salt Lake City, UT (Salt Lake City, UT) February 24, 2017 1295.00 Dollar US$

    Course "Writing and implementing effective SOP's" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion Overview: An SOP is a meticulous step-by-step description of how to do a...

  • Introduction to Industrial Statistics 2017

    Introduction to Industrial Statistics 2017

    Training and Teaching Salt Lake City, UT (Salt Lake City, UT) February 24, 2017 1295.00 Dollar US$

    Overview: This is an introductory course in industrial statistics that will equip the attendee to understand what he or she needs to know about basic descriptive statistics such as measurements of central tendency (average) and variation (range and s...

  • Quality by Design - Essential Techniques for Medical Devices 2017

    Quality by Design - Essential Techniques for Medical Devices 2017

    Training and Teaching Salt Lake City, UT (Salt Lake City, UT) February 24, 2017 1295.00 Dollar US$

    Overview: Design Controls are essential for producing safe and effective medical devices. And Design Controls are considered a critical process by the FDA. Yet, Design Controls are still one of the most frequent areas for 483 and Warning Letter obser...

  • New FDA FSMA Rules and Food Safety Controls 2017

    New FDA FSMA Rules and Food Safety Controls 2017

    Training and Teaching Salt Lake City, UT (Salt Lake City, UT) February 24, 2017 1295.00 Dollar US$

    Course "Preparing to Comply with the New FDA FSMA Rules: Planning Valid Preventive Food Safety Controls" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Upon c...

  • HIPAA Training Programs 2017

    HIPAA Training Programs 2017

    Training and Teaching Salt Lake City, UT (Salt Lake City, UT) February 24, 2017 1295.00 Dollar US$

    Overview: 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 chang...

  • Safety, Health & Environment Management System  2017

    Safety, Health & Environment Management System 2017

    Training and Teaching Baltimore, MD (Baltimore, MD) February 24, 2017 1295.00 Dollar US$

    Course "How to build a complete Safety, Health & Environment Management System through Standards & Practices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Ove...

  • Quality by Design using Design of Experiments (QbD) 2017

    Quality by Design using Design of Experiments (QbD) 2017

    Training and Teaching Baltimore, MD (Baltimore, MD) February 24, 2017 1295.00 Dollar US$

    Course "Quality by Design using Design of Experiments (QbD)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion Overview: This seminar focuses on how to establish a systemat...