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   presents a proven, 3-day face-to-face training class:

 

FDA Auditing of Computerized Systems

and Part 11/Annex 11

EduQuest's most popular classroom course for 20 years.

 

   Understand and comply with FDA and EU rules for data integrity and security

 

   Learn from the very best: instructors who wrote the regulations, teach FDA inspectors, train industry Quality and IT specialists, and who themselves were expert FDA investigators

 

   Learn how to ensure your records and reports withstand the toughest scrutiny by FDA and third-party inspectors

 

   Be taught real-world ways to audit the proper validation of COTS, custom, hybrid, and vendor-hosted (cloud-based) computerized systems

 

 

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.

 

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, including “Software as Service” and cloud computing

 

This course also includes a complete update on FDA’s latest Part 11 “tag-along” inspection initiatives and a thorough explanation of the EU's Annex 11 rules and their relationship with Part 11.

 

 

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

and inspection readiness training from the same instructors

who trained FDA and Health Canada inspectors and officials.

 

This course is based on the curriculum 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.

Examine the FDA Auditing of Computerized Systems curriculum

Review the qualifications & experience of your course instructors

See what students and clients say about EduQuest courses and instructors

Check the latest schedule of course dates

Get class registration and tuition information -- learn how to register

 

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:

 

 

"Unsolicited plug: EduQuest seminars are excellent! If you can attend, you should. I've been to several of your seminars over the years, enjoy them, and always leave with a pile of new information. If you can get your management (CxO or director-level people and IT staff to attend, you should." (Doug Finner, Elbit Systems, May 2011)

 

 


 

Course Curriculum:

FDA Auditing of Computerized Systems and Part 11/Annex 11

 

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

 

"Unsolicited plug: EduQuest seminars are excellent! If you can attend, you should. I've been to several of your seminars over the years, enjoy them, and always leave with a pile of new information. If you can get your management (CxO or director-level people and IT staff to attend, you should." (Doug Finner, Elbit Systems, May 2011)

 

 

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.

"I'm a strong advocate for EduQuest's Computerized Systems and Part 11 training. Give my best regards to Martin Browning and the whole team of professionals at EduQuest." (Julian Goins, Sr., Computerized Systems Quality Assurance Manager, UCB Pharma, June 2012)

 

"Incredible experience and knowledge of the FDA. Good [course] structure/buildup to activity.” (April 2013)

 

"[I liked] the knowledge and experience of the speakers and the mock audit. Thank you very much, Martin Browning!" (April 2013)

 

 

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.

 

“[I enjoyed] the ability to receive information directly from a former FDA investigator. It was also good to hear the Q/A from various individuals from various locations and companies.” (April 2009)

 

 

 

 

 

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.

 

“Denise is a very entertaining instructor, one of the best I've ever met...The class was very engaged.” (April 2013)

 

 

 

 

 

 

Sharon A. Strause is a national authority on computer systems validation and a member of EduQuest's global consulting and training team. She has more than 20 years of experience in the pharmaceutical and medical device fields, including 15 years at McNeil Consumer & Speciality Pharmaceuticals, a Johnson & Johnson Company. For seven of those years, Sharon managed the Quality Sciences and Compliance Document Control Group that established standards, policies and practices for documentation. She also was responsible for computer system validation on the McNeil/JJMCP SAP project. Sharon is a member of the advisory board of the Institute of Validation Technology (IVT), and she is the editor of the Computer Validation Forum published in the Journal of Validation Technology. She received an Industry Recognition Award from IVT in 2004.

 

I was very impressed with the course. Let me congratulate you on coming up with what was both incredibly resourceful and entertaining at the same time.” (April 2013)

 

 

 

 

 


 

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, international guidelines, and EduQuest compliance advisories.

 

The CD has been designed by the class 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, Part 11, Annex 11, other key ICH, GHTF and European Union guidelines, and much more.

 

ValidationVaultTM Resource CD Table of Contents

 


 

Latest Schedule of Course Dates:

 

FDA Auditing of Computerized Systems and Part 11/Annex 11

 

Monday through Wednesday, March 23-25, 2015

DoubleTree by Hilton Hotel, Bethesda Maryland (near Washington, DC). Hotel is 4 blocks from 2 Washington, DC Metro Subway stops and within walking distance of more than 150 shops and international restaurants.

 

8:30 a.m. - 5:00 p.m. each day. Lunch and refreshments provided.

 

Fly into one of three major area airports: Reagan National Airport (DCA), Baltimore-Washington International (BWI) Airport or Washington Dulles International (IAD) Airport.

 

Discounted sleeping rooms are available for $179 per night (plus tax) until February 22, 2015. After that date, rooms may still be available but likely will be at a higher rate.

 

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. As a general rule, you should have at least 15-20 students to make on-site training cost-effective. Request a price quote from ClarenceDanielson@EduQuest.net.

 


 

Registration and Tuition Information --

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

 

1. Click on red button to download Registration Form, then fax to EduQuest at +1 301-874-6031 or email to EduQuest.

2. Or Email Martin at Info@EduQuest.net with any questions you may have about the course content or logistics.

3. Or call +1 (301) 874-6031 between 9 a.m. and 5 p.m. Eastern U.S. Time and charge your tuition to a major credit card

(Visa, MasterCard, American Express).

 

Tuition for FDA Auditing of Computerized Systems and Part 11/Annex 11 is $2,995, including course printed materials; EduQuest's ValidationVaultTM Resource CD-Rom; ample time to ask your questions to the expert instructors; three lunches and continental breakfasts; refreshments throughout the program; and a Certificate of Attendance to document your training to FDA and third-party inspectors as well as to your management.

 

Save with a Team Registration:

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. Email Martin at Info@EduQuest.net for details.

 

Save with Extended Training:

Combine this course with either the 12-hour Managing and Auditing Supplier Quality course or the 12-hour CAPA Clinic: Effective CAPA Systems, Failure Investigations and Complaint Management (both offered on Thursday through early Friday afternoon, March 26-27, in Bethesda, MD) and save $495 on the combined  course tuition.

 

 

RETURN TO EDUQUEST CURRENT COURSES SUMMARY PAGE HERE

 

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