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:
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:
Part 11 rules for electronic records and signatures
How Part 11 compares with the EU’s new Annex 11
Key principles of computerized system validation
Validation documents and other deliverables FDA inspectors want to see
Why lots of quality assurance resources are wasted on ineffective or inadequate validation
Compliant solutions to validating “cloud” networks and vendor-supplied services
How to identify, document and report computerized system validation deviations
Top validation errors cited in FDA enforcement actions
Proactive steps to avoid CSV and Part 11 Form 483s and warning letters
Change control and configuration management
Ensuring audit trails and secure data access and transfer
Evaluating software vendor compliance claims
Current status of Part 11 – revisions, rewrite or abandonment?
How to prepare for the FDA inspector – using a simulated inspection with real-world scenarios
FDA Auditing of Computerized Systems and Part 11/Annex 11
Course Curriculum: 3 days, 8:30 a.m. – 5:30 p.m. each day
FDA and Computerized System Validation
Which validation deliverables the FDA expects and what they should contain
Why so many compliance dollars and resources are wasted on ineffective or inadequate validation
How the FDA defines a systems risk, plus mitigation strategies you can deploy
FDA Guidance on Part 11 Scope and Application
Part 11 rules for electronic records and signatures
Paper vs. electronic? Ensuring electronic data correlates to paper records
Why data integrity is critical with or without Part 11
Current status of Part 11 – revisions, rewrite or abandonment?
Annex 11: EU's New GMP Requirements for Computerized Systems
Relationship of European Union (EU) directives and GMP guides
Key principles of the newly revised Annex 11
Increased impact on risk, suppliers, and project/lifecycle management
Overlaps and differences compared to Part 11
Computerized System Development Model and Methods
Proven techniques for developing compliant software
Change control and configuration management
Data and information resources
Key Principles and Techniques for Computerized System Validation
Five pillars required for effective CSV, including: system management and monitoring, system change management, vendor management and CSV methodology management
Keys to maintaining your systems in a validated state
How to identify, document and report computerized system validation deviations
Ensuring audit trails and secure data access and transfer
Applying CSV to various types of systems, including legacy systems
Evaluating software vendor compliance claims
Regulatory Enforcement – Overview and Recent Trends
Top validation errors cited in FDA enforcement actions
Proactive steps to avoid CSV and Part 11 Form 483s and warning letters
Workshop: Simulated Inspection of Computerized System Development
How to prepare for the FDA inspector – using a simulated inspection with real-world scenarios
Learn how to apply effective auditing techniques
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.
Gordon B. Richman is Vice President of Strategic Compliance Consulting and the General Counsel of EduQuest. He joined the company in January 2002. Gordon brings a unique background and over 20 years of regulatory, legal, and corporate management experience to EduQuest, including more than 10 years in increasingly responsible senior management positions with leading pharmaceutical and medical device companies, first as Director of Worldwide Quality Strategy in GlaxoSmithKline’s Global Manufacturing and Supply operations, and then as Vice President of Regulatory Compliance at Fisher & Paykel Healthcare and Vice President of Regulatory Affairs at Masimo Corporation.
Previously, Gordon spent several years in FDA regulatory practice with major law firms in Washington, D.C., where he advised and defended pharmaceutical and medical device companies on a broad range of FDA regulatory issues. He has a broad base of experience in the complex, cross-functional issues faced by the FDA-regulated industries, including matters that span across manufacturing and supply, research and development and information technology.
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
Unabridged text of laws enforced by FDA
Unabridged text of key regulations enforced by FDA – Title 21 CFR
Library of FDA Guidance Documents related to computerized systems, software, electronic records/signatures and other automated systems
FDA warning letters related to automated systems used for GxP compliance
International Guidance Documents and guidelines (including PIC/S, GHTF, ICH, and EudraLex)
2012 Course Schedule:
8:30 a.m. - 5:30 p.m. each day. Lunch and refreshments provided.
September 24-26, 2012: Hilton Garden Inn Hotel, Frederick Maryland (near Baltimore and Washington, DC). www.frederick.stayhgi.com. 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.
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 September 24-26, 2012 course in Frederick, MD)
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 Compliance or the 1- ½ day CAPA Clinic, and save even more 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