 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.
CfPIE is proud to offer a 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 world wide – from conducting clinical trials overseas to filing efficient, compliant submissions with foreign regulators.
Topics covered include how to avoid common regulatory pitfalls in Latin America, Europe, Japan and other regions. Additionally, this program provides the flexibility to tailor your certification to meet your specific educational objectives. Just select three of the following core courses and one elective that best suit your area of responsibility:
Select three of the following core courses and one elective that best suit your area of responsibility:
Core Courses (Choose Three):
- Comprehensive Overview of FDA Regulatory Compliance for Drugs and Biotech Products
- Overview of FDA Regulatory Compliance for Medical Devices
- European Filing and Registration Procedures
- Japan — Regulatory Filing Requirements and Compliance Processes for Life Sciences
- Latin America — Understanding Regulatory Compliance Requirements
- Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications
- The EU Clinical Trial Directive
Elective Courses (Choose One):
- cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices
- The CTD/eCTD: Building the Marketing Application Throughout Clinical Development
- Good Manufacturing Practices (cGMP)
- Drug Master Files (DMFs) — Understanding and Meeting your Regulatory and Processing Responsibilities
- Adverse Drug Events — Understanding and Reporting Requirements
- FDA Inspections — What to Expect & How to Prepare
- Good Clinical Practices (GCPs)
- Pharmaceutical, Biopharmaceutical and Biologics Quality Control Laboratories – A Regulatory Compliance Primer
- Quality Systems Regulation for the Medical Device & Biotech Industries
- CMC Regulatory Compliance for Biopharmaceuticals and Biologics
If you have multiple staff that would benefit from this certification, we can offer these programs at your facility as part of a "certification series." For more information, contact us at +1-610-688-1708 or email us at info@cfpie.com.
|
Courses by Type
Certification Programs
& Transportation
The Center for Professional Innovation & Education®