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FDA Auditing of Computerized Systems

and Part 11/Annex 11

EduQuest's most popular course for more than 15 years


Get 3 days of hands-on Part 11/Annex 11 compliance

and inspection prep training from the same instructors

who trained the FDA and Health Canada


Keep your company safe from FDA’s stepped-up enforcement in three areas directly impacted by Part 11 and computer systems validation:


  1. Data integrity, especially in product manufacturing and clinical trials
  2. Supplier quality assurance
  3. Audit trails and change control in virtual computing environments


This course also includes a complete update on FDA’s latest Part 11 “tag-along” inspection initiatives.


Learn from former FDA investigators and policy-makers,

including the author of the original Part 11 rules,

as well as expert advisors who train and consult for global industry


Receive expert advice from ex-FDA senior officials, former inspectors, and industry authorities.


This course is based on a program EduQuest originally developed at FDA’s request to train agency field investigators, analysts and compliance staff on Part 11 rules and the inspection of computerized systems. Later, EduQuest provided similar training to Health Canada's headquarter officials and field investigators.


The basic curriculum continues to be used by FDA to train its inspectors through the Agency's "ORA-U" (Office of Regulatory Affairs University) series of online courses.


Learn FDA and EU rules for data integrity and security,

plus how to ensure your records and reports withstand

the toughest scrutiny by FDA and third-party inspectors


You’ll be trained on:



FDA Auditing of Computerized Systems and Part 11/Annex 11

Course Curriculum: 3 days, 8:30 a.m. – 5:30 p.m. each day



About Your Course Instructors:

Industry Pros and Former FDA Investigators and Policy-Makers

Click here to see what students and clients say about EduQuest courses and instructors


Martin Browning is the President and Co-Founder of EduQuest, Inc., a global team of FDA compliance experts based near Washington, D.C. Martin has more than 30 years of regulatory experience at the FDA and as a highly sought-after advisor to industry. His 22-year career at FDA included work in the field offices as an investigator and as a senior manager in the Office of Regulatory Affairs at FDA headquarters. He capped his FDA career by serving as a special assistant to the Associate Commissioner for Regulatory Affairs. He also served as vice chair of FDA’s electronic record and signature working group, where he helped draft the original 21 CFR Part 11 regulations. In addition, Martin served as the chair of the U.S. government’s ISO 9000 committee and was a member of the FDA committee that developed the medical device Quality System Regulation (QSR).


At EduQuest, Martin helps clients solve problems related to FDA regulation, quality assurance, software and systems engineering, and compliance auditing, including the assessment of vendors and outsourced operations. His specific experience also includes quality systems design, system design assurance and verification, and the validation of biopharmaceutical and device systems, processes and software. Martin was named Speaker of the Year in 2004 by the Institute of Validation Technology (IVT) and has received dozens of other awards from the FDA, DIA, ASQ, and other organizations.


Denise Dion is a Vice President of Regulatory and Quality Services with EduQuest. She spent 18 years of her career with the FDA, where she served as an Office of Regulatory Affairs (ORA) headquarters’ authority on agency-wide inspections and investigations. She developed many of FDA’s inspection guidance and training materials, including serving as the primary editor of the Investigations Operations Manual (IOM). Denise was the primary contact for interpretation and request for changes and additions to the IOM.  In addition, she was one of the authors and trainers of the Quality System Inspection Technique (QSIT).  For her EduQuest clients, Denise provides regulatory guidance and regularly conducts facility audits to assess compliance with drug, medical device and biologics regulations.


Janis V. Olson is a Vice President of Regulatory and Quality Services with EduQuest. Previously, she worked at FDA for more than 22 years, where among other responsibilities she conducted domestic and international inspections of FDA-regulated companies. Currently, Janis helps clients comply with GxP regulations worldwide. She also helps companies prepare for FDA inspections through training, writing and updating SOPs, and reviewing computer validation documentation. Janis was on the PDA task force that wrote the Generation Electronic Records Management (GERM) documents and has served as chair of the PDA Industry Advisory Board for audits of computer system suppliers. She was an instructor for EduQuest’s national FDA training program on Part 11 and has written web-based training on computer system validation and Part 11.


Register today to reserve your free copy of the ValidationVaultTM Resource CD


Receive the ValidationVaultTM Resource CD – an electronic reference library of FDA compliance resources – free with your Boot Camp attendance. A $295 value, the Resource CD gives you desktop access to a treasure-trove of FDA laws, regulations and guidance; inspection protocols; warning letters, and international guidelines.


The CD has been designed by the Boot Camp instructors specifically for those involved in computerized systems validation, quality management, software development, or electronic records/signatures compliance. Included in the ValidationVault Resource CD are the latest versions of  FDA’s Investigations Operation Manual, relevant Title 21 CFR regulations, a complete library of FDA guidance documents related to validation and Part 11, key ICH guidelines, and much more.


ValidationVaultTM Resource CD Table of Contents


2013 Course Schedule:

8:30 a.m. - 5:30 p.m. each day. Lunch and refreshments provided.

April 8-10, 2013: Hilton Garden Inn, Frederick Maryland (near Baltimore, Maryland and Washington, DC). For sleeping room reservations, visit www.frederick.stayhgi.com or call +1 (866) 909-6090. Use Group Discount code QUEST1 for sleeping rooms at $119/night plus tax. Discount rate available until March 18, 2013.


Fly into Baltimore-Washington International (BWI) Airport or Washington Dulles International (IAD) Airport, each approximately a 1-hour drive from Frederick.


To be notified when additional dates and locations are confirmed, subscribe to EduQuest’s free monthly newsletter delivered by email, EduQuest-ions & Answers. Click here to subscribe.


Date and location don't fit your schedule?

On-site, on-demand training is available when and where you need it

This course can be delivered directly at your facility, when and where convenient for you and your colleagues. Request a price quote from ClarenceDanielson@EduQuest.net.



Class registration is easy. To enroll or get more details:


(download Registration Form for April 8-10, 2013 course in Frederick, Maryland)


Or Email Martin at Info@EduQuest.net

Or call +1 (301) 874-6031 between 9 a.m. and 5 p.m. Eastern U.S. Time


Tuition for the FDA Auditing of Computerized Systems and Part 11/Annex 11 course is $2,795.


Register 5 students for the price of 4. Significant discounts also are available for teams of 2 or more from the same company who register together.


Combine this course with either the 1- ½ day course on Quality Risk Management for FDA/ICH Q9 Compliance or the 1- ½ day CAPA Confidence Clinic: Effective CAPA Systems, Failure Investigations, and Complaint Management -- each offered Thursday-Friday, April 11-12, 2013, in Frederick, Maryland -- and save even more on the combined course tuition.




EduQuest: EDUcation: QUality Engineering, Science and Technology   www.EduQuest.net    +1 (301) 874-6031