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:

RAPS’ onsite 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

RAPS’ faculty of active regulatory professionals and subject matter experts provide a topic-specific curriculum for your regulatory staff. Every company faces unique and specific challenges and RAPS will work with you to manage your regulatory education and staff development goals in the context of your own business issues.

Communication Skills:

• Dangerous Documents: Avoiding Land Mines in Your FDARecords and Emails—Employees will learn how to avoid the pitfalls and receive best practices on what they should write in their emails and other documents.

• Creating Documentation to Show FDA Compliance—During this interactive session, regulatory, quality, scientific and technical personnel will learn techniques to write well-organized and accurate documents while under tight deadlines.

• Talking to Decision Makers: What to Say and How toSay It—Participants learn how to prepare and describe an issue in 30 seconds and will learn how to respond to probing questions.

• Strategies in Meetings: Achieving Your Objectives—Case studies and role playing exercises are used to demonstrate techniques that will improve the attendees’ ability to convey information.

Technical Knowledge & Skills:

• Regulatory Onboarding
• Technical/Medical Writing
• Regulatory Strategy
• Advertising & Promotions
• Chemistry, Manufacturing & Controls (CMC)
• 510 (k) Process
• Quality Systems
• Premarket Authorizations
• Submissions Strategies