Receive a Global Regulatory Affairs Certification (GRACP)

CfPIE is proud to offer a regulatory affairs certification program that will help participants face even the toughest global regulatory compliance challenges. The Global Regulatory Affairs Compliance Professional (GRACP) program will give participants the skills necessary to work with regulatory agencies worldwide - from conducting clinical trials overseas to filing efficient, compliant submissions with foreign regulators.

In an increasingly global market, sifting through the mountains of disparate regulations, mandates and guidelines can seem an almost impossible task. However, with the opening of foreign markets and the marketing opportunities that result, understanding global regulations is more important than ever.

Topics covered include how to avoid common regulatory pitfalls in Europe, Japan and other regions. Additionally, this regulatory affairs certificate program provides the flexibility to tailor your certification to meet your specific educational objectives. To join this program and become RAC certified simply select three of the following core courses and one elective that best suit your area of responsibility.

Certification Program FAQs

Regulatory Affairs Certification Requirements:

  1. Choose 3 Core Courses from any of the courses listed below.
  2. Choose 1 Elective Course from any of our other classroom courses.
Foundational Comprehensive Overview of FDA Regulatory Compliance for Drugs and Biotech Products
Foundational Electronic Common Technical Document (eCTD) Submission Training - US vs EU, with Global Insight
Foundational European Regulatory Procedures - EMA and National Requirements
Foundational European Union Regulatory Issues – New Product Development
Foundational FDA Inspections – What Regulators Expect & How to Prepare
Foundational Good Manufacturing Practices Training | GMP Course
Foundational Introduction to Medical Combination Products
Foundational Marketing and Advertising of Pharmaceuticals & Medical Devices
Foundational Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems
Advanced Medical Devices: The New MDRs, EU Directives, Guidance, CE Marking and ISO Standard Certifications
Foundational Overview of FDA Regulatory Compliance for Medical Devices
Foundational Pharmaceutical Production Batch Record Review
Foundational Product Quality Reviews
Foundational QbD - Product and Process Optimization using Design of Experiments
Foundational Qualifying, Management and Auditing of Contract Manufacturing Organizations
Foundational Selecting and Managing CROs
Foundational The Drug Development Process from Concept to Market
Foundational Understanding & Implementing New EU Clinical Trial Regulation & GDPR

Get Your Regulatory Affairs Certification

If you have 10 or more employees that would benefit from regulatory compliance certification, we can offer complete program tracks on-site at your facility. For more information, call us at 1-610-648-7550 or contact us.

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