TrAininG Courses

We Trained FDA and are Now Offering Our Courses to the Industry!
Training
Courses
FDA is continuing to update its approach to GMP, quality systems, 21 CFR Part 11, risk management, and the industry’s use of new
process analytical and control technologies. At the same time, the industry is increasing its reliance on software, computerized systems,
and other advanced technologies to support and streamline manufacturing, clinical, laboratory, and other regulated operations. Because
quality system, validation, and computerized system issues continue to be sources of controversy and frequently cited deviations during
FDA inspections, it is critically important for today’s technology-dependent companies to understand and prepare for FDA’s shifting
priorities and inspectional scrutiny in these areas. Our most popular training courses focus specifically on these issues, and we are now
offering more courses in parallel tracks to allow you to choose the training that best fits your company’s needs. We invite you to take
advantage of this unique opportunity to learn from the same expert team that trained FDA.
FDA Auditing of Computerized Systems
and Part 11
The CAPA Clinic: Effective CAPA Systems
and Failure Investigations
3 days – Monday through Wednesday
12 hours
Class Schedule - 8:30 AM - 5:30 PM
7:45 — 8:30 Breakfast
8:30 — Course Begins
5:30 — Adjourn
Course Objectives:
r Understand what FDA expects of regulated industry
r Learn which validation deliverable FDA expects and what
they should contain
r Understand the basic principles of good software
engineering practice
r Apply effective auditing techniques
r Understand the reasons for, and history of, FDA’s interest in
computerized system validation
r Understand which systems FDA has an interest in, or
regulates, and why
r Find and use data and information resources provided by
EduQuest
r Learn the origin of FDA’s requirements in law and regulation
r Understand the importance and impact of 21 CFR Part 11
r Learn how the regulatory enforcement environment is
changing
Course Curriculum:
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?
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
ValidationVault Resource CD included
with your registration
TM
Receive the ValidationVault Resource CD – an electronic
reference library of FDA compliance resources – free with your
attendance at the FDA Auditing of Computerized Systems and
Part 11 course. 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.
TM
The CD has been designed by the course 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)
If you are interested in having these courses
delivered directly at your site, contact us by
phone, 301-874-6031
or email, [email protected].
Anaheim, California – March 21-25, 2011
Thursday – 8:30 AM – 5:30 PM
Friday – 8:30 AM – 12:30 PM
Course Objectives:
r Upgrade your current CAPA system, giving you confidence
the next time FDA visits
r “Correctly” identify corrections, corrective actions and
preventive actions so you don’t waste time and resources in
solving the wrong problems
r Speak the same language as the regulators when identifying
and describing non-conformities
r Identify the best CAPA data sources and gather useful
feedback from throughout your organization
r Select and apply appropriate CAPA tools to resolve
real-world quality issues
r Conduct a proper failure investigation and accurately identify
root causes
r Use statistics to find and fix CAPA problems
Doubletree Hotel Anaheim/Orange County
100 The City Drive, Orange, CA 92868-3204
(714) 634-4500
13 miles from John Wayne Airport/Orange County
Wilmington, Delaware – July 25-29, 2011
The Hotel DuPont
11th & Market Streets, Wilmington, DE 19801
(302) 594-3125
Near I-95, Amtrak, and Philadelphia Int’l Airport
Providence, Rhode Island – Sept. 26-30, 2011
The Hilton Providence
21 Atwells Avenue, Providence, RI 02903
(401) 831-3900
8 miles from TF Green Airport (Providence)
Course Curriculum:
Regulatory Requirements for CAPA
Three courses to choose from
Elements of Effective CAPA Systems
For the best value and use of your time, choose either
EduTrack A or EduTrack B, or select individual
courses. Quality Risk Management and The CAPA
Clinic are run concurrently, so select the course that
best meets your needs.
CAPA Tools
The EduTrack –
 FDA’s requirements for Corrective and Preventive Action systems
 Why CAPA systems continue to be at the top of FDA’s
enforcement list.
 Framework for a compliant CAPA system
 Definitions of a correction, corrective action, and preventive
action – and why the difference matters
 CAPA data sources – gathering feedback from throughout your
organization
 Recommended flow chart for CAPA data collection and closure
 Picking the right CAPA tracking tools
2 back-to-back courses
for $3,980 USD ($310 savings)
____ EduTrack A: FDA Auditing of Computerized
Systems and Part 11 (Monday through Wednesday)
AND Quality Risk Management for FDA Compliance
(Thursday and Friday)
What to Look for in Failure Investigations/Root Cause Analysis
 How to conduct a proper failure investigation to its root cause
 Failure Investigations Tools
Trending Requirements and CAPA
 Drug and device trending requirements – what and when to trend
 Use of statistics to find and fix CAPA problems
 Use of Risk (Process, Product) to determine need to escalate to
a CAPA
____ EduTrack B: FDA Auditing of Computerized
Systems and Part 11 (Monday through Wednesday)
AND The CAPA Clinic: Effective CAPA Systems and
Failure Investigations (Thursday and Friday)
Or Register for any of these individual courses:
Quality Risk Management
for FDA Compliance
Agency Expectations • Global Standards • Tools for Success
12 hours
Thursday – 8:30 AM – 5:30 PM
Friday – 8:30 AM – 12:30 PM
Course Objectives:
r Speak the same language of “risk” with inspectors,
regulators, and ISO auditors
r Articulate the pay-back of risk management to senior
management
r Know how to meet U.S. and international standards for risk
management
r Identify and assess risks by applying the right tools to realworld situations
r Use risk management to upgrade your GxP programs and
improve electronic record-keeping systems
r Incorporate lifecycle risk management in your products and
processes
r Apply a consistent, documentable approach to risk
management throughout your company
Course Curriculum:
Definitions: Getting Proficient in the Language of Risk
 Concepts and definitions used by FDA
 Differences between FDA and ISO/ICH terms
 Relationship between “use” and “risk”
Regulatory Foundations
 The history of managing risks in drugs and devices
 Current FDA rules mandating risk management
 Latest FDA/ICH guidance and policies
Overview of Risk Management Approaches
 FDA’s “3P” expectations for managing
 Role of risk management in compliant GxP and electronic
record-keeping systems
Key Principals of Risk Management
 Relationship of Severity, Likelihood and Detectability
 Introduction to tools for risk assessment and hazard control
 Learning which tools work best in what situations
Risk Management Planning
 Methods for integrating risk management with your quality system
 Using risk management to better understand and improve
processes
 Lifecycle risk management – why it’s critical, and when it’s
required
The Risk Assessment Process
 The ISO 14971 risk management model
 How Six Sigma and the risk management process interact
The Initial Risk Evaluation
On-Site Training Available
2011 Course Locations and Dates
 Proven tools to assess, evaluate and prioritize risks:
– Processing mapping and HAZOP
– Ishikawa diagrams and Fault Trees
– HACCP and FMEA
____ FDA Auditing of Computerized Systems
____ Quality Risk Management for FDA Compliance:
____ The CAPA Clinic: Effective CAPA Systems and
For registration or additional
information, please contact us at:
Mail:
EduQuest, Inc. 1896 Urbana Pike,
Suite 14
Hyattstown, MD 20871 USA
Complying with FDA’s Medical Device
21 CFR 820 Quality Systems Regulation
Meeting FDA’s 21 CFR 820.30 Rules for
Quality Design and Manufacturing
1½ Day Training Class
Tuesday – 8:30 AM – 5:30 PM
Wednesday – 8:30 AM – 12:30 PM
Course Content:
r FDA’s Evolving Approach to Quality Systems
r Introduction to FDA’s Quality Rules for Medical Devices
r ISO/ICH Approaches to Quality Systems
r QSR Management Review and Control (Subpart B)
r QSR Design Controls/System Development (Subpart C)
r QSR Production and Process Controls (Subparts G, O)
r QSR Corrective and Preventive Actions – CAPA
(Subparts J, I, N)
r The Yin/Yang of Method Design/CAPA
r QSR Laboratory Controls (Subpart I)
r Conducting Failure Investigations
r QSR Documents, Records and Change Control (Subparts D, M)
r QSR Facility and Equipment Controls (Portions of Subpart G)
r QSR Material Controls (Subparts E, F, H, K, L)
r How to Prepare for an FDA QSR Inspection
r FDA Enforcement Priorities
2½ Day Training Class
Wednesday – 1:30 PM – 5:30 PM
Thursday – 8:30 AM – 5:30 PM
Friday – 8:30 AM – 12:30 PM
Course Content:
r Why Does FDA Require Design Controls?
r FDA Guidance for Design Control
r Design and Development Planning – 21 CFR 820.30 (b)
r Design Review – 21 CFR 820.30 (e)
r Design Input – 21 CFR 820.30 (c)
r Design Output– 21 CFR 820.30 (d)
r Design Verification– 21 CFR 820.30 (f)
r Design Validation– 21 CFR 820.30 (g)
r Design Change – 21 CFR 820.30 (i)
r Design Transfer to Manufacturing – 21 CFR 820.30 (h)
r Lessons Learned in Design Transfer
r Design History File (DHFs) – 21 CFR 820.30 (j)
Call: 301.874.6031
Fax: 301.874.6033
E-mail: [email protected]
Website: www.EduQuest.net
Cancellations/Substitutions: Company substitutions are not
permitted without prior notification to EduQuest. Cancellations received
before the beginning of a course will be subject to a refund according to
the following schedule and rates. Up to 6 PM EST, 10 business days
in advance of the course, a 95% refund will be provided. If less than 10
business days advance notice is provided, the refund amount will be
50%. Individuals requesting to change course location will be charged
a $500 course transfer fee if less that 10 business days before course.
No-shows will be charged the full amount. EduQuest reserves the right
to cancel the courses and is not responsible for any airfare, hotel, or
other costs incurred by registrants.
Risk Management Reports and Communication
 What factors you should document in your overall risk evaluation
 Communicating risks: key principles and best practices
 Identifying risk communication audiences
Post-Launch Reviews: Process Risk Performance and Feedback
 Monitoring ongoing risks throughout the product’s life
 Using quality system data to manage process risks during
commercial production
 Gathering and integrating feedback from the field
2011 Course Locations and Dates
Anaheim, California – March 15-18, 2011
Doubletree Hotel Anaheim/Orange County
100 The City Drive, Orange, CA 92868-3204
(714) 634-4500
13 miles from John Wayne Airport/Orange County
QSR and Design Control Courses Offer Compliance Guidance and Insights
for Device Manufacturers and Suppliers
Design Control for Medical Devices:
Failure Investigations
$1,495 USD – 1½ days
Thursday, 8:30 AM – 5:30 PM
Friday, 8:30 AM – 12:30 PM
 Understanding and accounting for residual risk
 How to factor risk mitigations into residual risk estimates
 The biggest mistakes companies make in implementing risk
mitigations
QSR Compliance Fundamentals:
Agency Expectations • Global Standards • Tools
for Success
$1,495 USD – 1½ days
Thursday, 8:30 AM – 5:30 PM
Friday, 8:30 AM – 12:30 PM
Mitigating Risk: Preparing and Implementing a Plan
The scope of FDA’s Quality Systems Regulation (QSR) is huge – more than 500 pages of rules and guidance – and
non-compliance is not an option. Just within the past 18 months, 27 medical device companies received Warning
Letters for deficient quality management programs, and several were threatened with removal of their products from
the market. Enroll in these two new EduQuest courses – offered separately or as an integrated four-day learning
package – and learn how to develop a by-the-book quality management program so you stop spinning your wheels
with non-essential activities that waste time and money. Your instructors are former FDA investigators from the globally
recognized firm of EduQuest, including the founding editor and co-author of the FDA’s “bible” for inspectors, the
Investigations Operation Manual (IOM), as well as experts from the regulated community. The goal of both training
programs is to give you real-world, step-by-step compliance information. Through plain-English instruction, detailed
course materials, and interactive exercises that reinforce the lessons (not to mention making the classroom more fun
and interesting), you learn to cost-effectively comply with FDA’s QSR rules and related international standards.
and Part 11
$2,795 USD – 3 days
Monday through Wednesday
8:30 AM – 5:30 PM
Wilmington, Delaware – July 19-22, 2011
The Hotel DuPont
11th & Market Streets, Wilmington, DE 19801
(302) 594-3125
Near I-95, Amtrak, and Philadelphia Int’l Airport
Providence, Rhode Island – Sept. 20-23, 2011
The Hilton Providence
21 Atwells Avenue, Providence, RI 02903
(401) 831-3900
8 miles from TF Green Airport (Providence)
Two courses to choose from
For the best price and value, choose
the EduTrack or select individual courses.
The EduTrack – 2 back-to-back
courses for $3,195 ($280 savings)
____ All 4 Days of Training: QSR Compliance
Fundamentals AND Design Control for Medical
Devices
Or Register for any of these individual courses:
____ QSR Compliance Fundamentals: Complying
with FDA’s Medical Device 21 CFR 820 Quality
Systems Regulation
$1,495 USD – 1½ days
Tuesday, 8:30 AM – 5:30 PM
Wednesday, 8:30 AM – 12:30 PM
____ Design Control for Medical Devices: Meeting
FDA’s 21 CFR 820.30 Rules for Quality Design
and Manufacturing
$1,980 USD – 2½ days
Wednesday – 1:30 PM – 5:30 PM
Thursday – 8:30 AM – 5:30 PM
Friday – 8:30 AM – 12:30 PM
EduQuest, Inc.
1896 Urbana Pike, Suite 14
Hyattstown, MD 20871
301.874.6031
www.EduQuest.net
2011 Training Schedule
Compliance
Compliance Training from
Risk
CAPA
Quality
Validation
Inspections
Regulations
483s
Audits
EduQuest
Register Today!
March 2011 — Anaheim, California
July 2011 — Wilmington, Delaware
September 2011 — Providence, Rhode Island
www.EduQuest.net
301-874-6031
Also available
On-Demand
♦ “The mock audit pulled together many topic threads very effectively.”
Why Attend? Hear what others have said about:
Our Courses
♦ “Very powerful and useful training. My highest compliment is the I will
recommend this course to my colleagues.”
♦ “I believe that I have learned a lot. I also feel confident that I have
learned information that I can bring to my company and improve our internal processes. I appreciate the “examples” given to illustrate course content, this will help me retain and explain the information.”
♦ “One of the best training [courses] I ever attended.”
♦ “Material and presentation were excellent!!! Very informative about a
complex subject without being dry, boring or confusing. Content objectives were met and exceeded.”
♦ “I liked discussion of different tools. It will help me to implement the
concept in my work and it always helpful to understand that there is more than one way to perform risk analysis.”
♦ “What a great conference. I really appreciate the quality of the content
and presentations, the knowledge/educations/experience of your speakers, the skill level in presenting, handling of people and questions and the general organization of the experience from planning to sign up to attendance. Super Job!”
♦ “Felt like a toolbox of knowledge that was given to me.”
♦ “The whole course was good. I came to the course w/very little
understanding of the FDA, Part 11 and the processes attached. But I am leaving w/a good understanding.”
♦ “EduQuest has really helped us expand our quality system beyond ISO/
IEC 17025 to the FDA requirements. We are much more confident in
meeting our FDA needs! We are able to speak the language now as
well. Even though everyone wanted to be told exactly how to do things, the instructor was able to get across that we have to implement the regulations for ourselves and DOCUMENT why!”
♦ “This topic provided me with useful tools for auditing company’s
processes; i.e. terms of risk impact.”
♦ “This is the best course on the subject I’ve taken. I’ve learned
more relevant information this week, and from more knowledgeable instructors, than all the other courses combined.”
EDUcation: QUality Engineering, Science, and Technology
www.EduQuest.net
Martin Browning and the
EduQuest staff present:
•
FDA Auditing of Computerized
Systems and Part 11
•
Quality Risk Management for
FDA Compliance:
Agency Expectations • Global Standards
• Tools for Success
Anaheim, California
Doubletree Hotel Anaheim/Orange County
100 The City Drive
Orange, CA 92868-3204
(714) 634-4500
13 miles from John Wayne Airport/Orange County
Wilmington, Delaware
The Hotel DuPont
Effective CAPA Systems and Failure Investigations
11th & Market Streets
Wilmington, DE 19801
(302) 594-3125
Near I-95, Amtrak, and Philadelphia Int’l Airport
QSR Compliance Fundamentals:
Providence, Rhode Island
Complying with FDA’s Medical Device
The Hilton Providence
21 CFR 820 Quality System Regulation
21 Atwells Avenue
Providence, RI 02903
(401) 831-3900
8 miles from TF Green Airport (Providence)
•
•
•
2011 Course Locations:
The CAPA Clinic:
Design Control for Medical Devices:
Meeting FDA’s 21 CFR 820.30 Rules for
Quality Design and Manufacturing
EduQuest is a leading provider of regulatory
consulting, auditing, and training services to
the global pharmaceutical, biologics, and
medical device industries.
EduQuest’s areas of expertise include the
validation of regulated computer systems,
requirements for electronic records and
electronic signatures, process control and
validation, quality systems, internal auditing,
regulatory compliance and enforcement, and
the full range of “GxP” (i.e., good
manufacturing, good laboratory, and good
clinical practice) requirements.
On-Site Training Available
If you are interested in having these courses
delivered directly at your site, contact us by
phone, 301-874-6031 or email,
[email protected].
FDA Auditing of Computerized Systems
and Part 11
(3 days) – $2,795 USD
March 21-23, 2011 – Anaheim, CA
July 25-27, 2011 – Wilmington, DE
Sept. 26-28, 2011 – Providence, RI
Quality Risk Management for FDA Compliance:
Agency Expectations • Global Standards •
Tools for Success
(1½ days, 12 hours) – $1,495 USD
March 24-25, 2011 – Anaheim, CA
July 28-29, 2011 – Wilmington, DE
Sept. 29-30, 2011 – Providence, RI
The CAPA Clinic: Effective CAPA Systems
and Failure Investigations
(1½ days, 12 hours) – $1,495 USD
March 24-25, 2011 – Anaheim, CA
July 28-29, 2011 – Wilmington, DE
Sept. 29-30, 2011 – Providence, RI
QSR Compliance Fundamentals:
Complying with FDA’s Medical Device 21
CFR 820 Quality Systems Regulation
(1½ days, 12 hours) – $1,495 USD
March 15-16, 2011 – Anaheim, CA
July 19-20, 2011 – Wilmington, DE
Sept. 20-21, 2011 – Providence, RI
Design Control for Medical Devices:
Meeting FDA’s 21 CFR 820.30 Rules for Quality
Design and Manufacturing
(2½ days, 16 hours) – $1,980
March 16-18, 2011 – Anaheim, CA
July 20-22, 2011 – Wilmington, DE
Sept. 21-23, 2011 – Providence, RI
EduQuest also provides training to regulatory
agency personnel, and was hired by FDA to
train its field investigators, analysts, and
headquarters compliance staff (from all FDA
Centers) on 21 CFR Part 11 and the inspection
of computerized systems.
Our team of consultants includes former senior
FDA officials and industry experts in quality,
compliance, manufacturing, clinical research,
validation, and software development.
Course Dates and Tuition Investment:
To Register or obtain additional information
about our courses:
Why Attend?
Hear what others have said about:
Our Instructors
♦“All the instructors are knowledgeable, articulate
and dynamic. The instructors are the most valuable
part of the course.”
♦“Excellent to get presentations from ex-FDA [personnel]
with insights for the future . . .”
♦“All instructors appeared to have good in-depth
knowledge of all aspects of the material. They are also
good at presenting the material. Impressive!”
♦“Historical knowledge of the instructors and stories they
were able to share in order to drive points home was
invaluable.”
♦“Brilliant instructors.”
♦“Excellent trainer who obviously had relevant experience.”
Contact: Cece Bland
1896 Urbana Pike, Suite 14
Hyattstown, Maryland 20871
Tel: 301-874-6031 • Fax: 301-874-6033
E-Mail: [email protected]
www.EduQuest.net
F D A T R A ININ G NO W
AVA IL A BLE TO IN D US T RY
Take the same course and learn from
the same instructors who trained FDA!
Our course on “FDA Auditing of Computerized
Systems and Part 11” is based on the materials and
exercises that we were hired to develop and use to
train FD on inspecting and interpreting computerized
system validation and 21 CFR Part 11.