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Custom Corporate Training

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Every company faces unique and specific challenges. RAPS will work with you to manage your regulatory education and staff development goals in the context of your own business issues.

RAPS Onsite Training Programs Will Help You:

  • Improve employee performance by addressing knowledge gaps, enhancing understanding of topical areas and reinforcing regulatory best practices with the worldwide leader in regulatory affairs.
  • Maximize your training budget by reducing travel and lodging expenses for employees. Without ever leaving the building, staff can gain new skills, boost their confidence, and improve their productivity through RAPS professional development solutions.
  • Efficiently schedule and participate in training and learning solutions at a time and location that’s most convenient for your staff.

Our Approach

Our training includes proprietary content created from real-world regulatory competency requirements. The key to our success is our focused attention on your regulatory needs. Our consultative process concentrates on your goals and objectives and then recommends the most appropriate resources and solutions that will enable you to achieve these goals most effectively. Your staff will:

  • Fill skill and knowledge gaps and enhance understanding of specific topical areas in regulatory
  • Learn from and interact with leading subject matter experts to reinforce key learning objectives
  • Expand their roles in current areas of expertise, as well as expand their understanding of the full scope of the industry

Our Program Offerings

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Foundational Programs

  • Regulatory Onboarding
  • Regulatory Affairs Essentials
  • Regulatory Due Diligence
  • Regulatory Foundations Overview
  • Regulatory Strategy Overview
  • US Regulatory Affairs Overview
  • EU Regulatory Affairs Overview

Technical Knowledge & Skills Programs

  • EU Medical Device Regulation (MDR)
  • Software as a Medical Device
  • Chemistry, Manufacturing & Controls (CMC)
  • Investigational Device Exemptions (IDE) Submission Workshop
  • IVDR & eCTD
  • Submission Strategies
  • 510(k) Basics & Process
  • Premarket Authorizations
  • Advertising & Promotion
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Communication Programs

  • Writing for FDA and Top Executives
  • Avoiding Land Mines in Your FDA Records and Emails
  • Talking to Decision Makers: What to Say and How to Say It
  • Writing under Pressure: Making It Easy
  • Strategies in Meetings: Achieving Your Objectives
  • Technical/Medical Writing

Leadership Programs

  • Toolkit for the Emerging Regulatory Leader
  • Advanced Leadership Workshop
  • Executive & Leadership Development and Training
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Over 50 Online Courses

  • Regulatory essentials
  • Medical devices
  • Pharmaceuticals
  • Quality
  • Clinical