(GRACP) Global Regulatory Affairs Compliance Professional™

View Required Courses Certification FAQs

About Global Regulatory Affairs Certification Program

CfPIE’s Global Regulatory Affairs Certification Program (GRACP) is a comprehensive certification tract covering all aspects of regulatory affairs. GRACP iis available for individuals in the United States, Europe, Canada, Australia and Middle Eastern countries. Full List of Countries where we offer Pharma & Biotech and Medical Device Courses.

This program is designed to help professionals facing the toughest global regulatory compliance challenges by equipping participants with 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 certified simply select three of the following core courses and one elective that best suit your area of responsibility.

Contact a Training Advisor

We offer on-site pharmaceutical training and life science certification programs for organizations with 10 or more employees enrolling. Call us today at 1-610-648-7550 or Contact a Training Advisor.

Proceed To Required Courses Certification FAQs

Certification Requirements:

Choose 3 Core Courses from any of the courses listed below.
Choose 1 Elective Course (Can be a core course or any course listed at: Courses by Title)

Analytical Chemistry Principles for Pharmaceutical Scientists Auditing and Qualifying Suppliers and Vendors Biostatistics for Non-Statisticians Change Control - GMP Requirements and FDA Enforcement Cleanroom Fundamentals - Regulation, Science, Design, Practice, Operation & Management Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products Computer System Validation CRO, CDMO and Non-Clinical Vendor Management Fundamentals Development and Validation of Bioanalytical Assays for Biologics: Quantitation (PK) and Immunogenicity Assays Effective Document Management for Pharma, Biotech & Medical Device Effective Internal and External Quality Assurance Auditing for FDA Regulated Industries Ethics in Research - Values for Responsible Conduct of Research European Regulatory Procedures - EMA and National Requirements FDA Inspections – What Regulators Expect & How to Prepare Good Clinical Practices (GCP) & Risk Based Monitoring - Understanding and Implementing Current Global Requirements Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies Good Manufacturing Practices Training | GMP Course Human Error Prevention (HEP) - Risk Factors and Strategies Integration of Risk Management Principles and Activities into the Pharmaceutical Quality System Intro to Medical Device Submission - 510(k)s, PMAs & Exemptions Introduction to Medical Combination Products

Introduction to Statistical Analysis of Laboratory Data Introduction to Vaccines - CMC Regulatory and Quality Aspects Lyophilization Technology - Application of Scientific Principles Marketing and Advertising of Pharmaceuticals & Medical Devices Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems Oncology Drug Development Course - A Comprehensive Overview OTC Drug and Personal Care Product GMP & FDA Regulation Overview of FDA Regulatory Compliance for Medical Devices Overview of the New EU Medical Devices Regulations: MDR, IVDR, CE Mark and Compliance, QMS Fundamentals Pharmaceutical Production Batch Record Review Pharmaceutical Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy Preparation of FDA Submissions and Communicating with the FDA Preparing the CMC Section for NDAs/INDs/CTDs Process Validation for Drugs and Biologics QbD - Product and Process Optimization using Design of Experiments Quality Assurance/Quality Control for Biologics and Biopharmaceuticals Technical Writing for Pharma, Biotech and Med Devices The Drug Development Process from Concept to Market Writing Effective SOP and Other Process Documents

Certification Program Discounts

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

Pharma & Biotech Courses

Medical Device Courses

Skin & Cosmetics Courses

Since 2006 CfPIE has