About EduQuest — A global team of FDA compliance experts
Founded in 1995 by three former senior officials from the U.S. Food and Drug Administration (FDA), EduQuest is an internationally recognized provider of regulatory consulting, auditing, and training services to the global medical device, pharmaceutical, biologic, and tobacco industries.
Martin Browning, co-author of FDA’s original Part 11 rules for electronic records and electronic signatures and contributor to the development of FDA’s Quality System Regulation (QSR), is one of the co-founders of EduQuest and serves as its president.
Training – Auditing – Compliance Advice: What EduQuest can do for you
EduQuest provides practical FDA compliance and inspections training, auditing, and advice to industry and regulatory agency personnel.
EduQuest was hand-picked by FDA and Health Canada to train their field investigators and compliance staff on 21 CFR Part 11 and the inspection of computerized systems.
It was hand-picked by both the U.S. FDA and Health Canada (Canada’s “FDA”) to develop and train agency field investigators, analysts, and headquarters compliance staff on 21 CFR Part 11 and the inspection of computerized systems.
In addition, EduQuest provides online training to thousands of quality and regulatory specialists in industry as well as FDA field investigators and FDA Center policy-makers by managing more than two dozen e-learning courses presented by UL EduNeering through its ORA-University (ORA-U) and ComplianceWire learning platforms.
EduQuest’s team of full-time consultants and trainers includes former FDA investigators and policy-makers as well as industry experts in quality, compliance, manufacturing, auditing, clinical research, validation, software development,and design control.
Senior EduQuest staff members include Janis Olson, who served at FDA for 22 years as an expert field investigator and as the Director of Information Management Resources in FDA’s Atlanta regional office, and Denise Dion, who served at FDA for 18 years as an expert field investigator and was the co-editor of FDA’s Investigations Operations Manual (IOM) and the co-developer and trainer of FDA’s Quality System Inspection Technique (QSIT).
Further information on the professional experience and qualifications of EduQuest’s senior staff members is available here.
EduQuest’s specific areas of experience and expertise include:
- Internal auditing
- Inspection preparedness
- Supplier management and auditing
- Validation of regulated computer systems
- Developing SOPs for electronic records and electronic signatures
- Process control and validation
- Improving Quality Systems, including CAPA failure investigations and complaint management
- Quality risk management
- Design control processes and procedures
- Regulatory compliance, both in the U.S. and throughout the world
- Responding to 483s, Warning Letters and other enforcement actions
- And meeting the full range of “GxP” (i.e., good manufacturing, good laboratory, and good clinical practice) requirements
Training Classes that can be delivered at your site include:
- FDA Auditing of Computerized Systems and Part 11/Annex 11 (3 days)
- The CAPA Clinic: FDA Rules for Effective CAPA Systems, Failure Investigations and Complaint Management (12 hours)
- Quality Risk Management for FDA/ISO/ICH Compliance: Agency Expectations – Global Standards – Tools for Success (12 hours)
- QSR Compliance Basics: Complying with FDA’s Medical Device 21 CFR 820 Quality System Regulation (16 hours)
- Design Control for Medical Devices: Meeting FDA’s 21 CFR 820.30 Rules for Quality Design and Manufacturing (16 hours)
- Managing and Auditing Supplier Quality: FDA Expectations * Global Standards * Real-World Solutions (12 hours)
- FDA Expectations for Management Control (4 hours)
About this Q&A Information Center:
EduQuest maintains and updates this free FDA Compliance Q&A Information Center based on Frequently Asked Questions we receive from our clients, course alumni, and fellow FDA compliance professionals.
The site is fully indexed and search-able by keyword or specific FDA compliance challenge.
You’re welcome to share the information and guidance with your staff and colleagues.
We invite and encourage your feedback and questions about your own compliance concerns. Email us today at Info@EduQuest.net.
For more information about EduQuest’s experience, capabilities, and services:
- Visit www.EduQuest.net
- Email us at Info@EduQuest.net
- Or call +1 (301) 874-6031 between 9:00 a.m. and 5:00 p.m. Monday through Friday, Eastern U.S. time.