PAYMENT ABOUT CfPIE

$2150.00 PER PERSON (INCLUDES BREAKFAST & LUNCH) Learn from the Leader

EARLY BIRD DISCOUNT In a life sciences industry that has faced nearly $15 billion in fines and
compliance-related settlements over the last several years, The Center
If you register at least thirty days in advance you will receive a for Professional Innovation & Education (CfPIE) is a better alternative
COMPUTER SYSTEM
$200 discount on the course. for maintaining high standards, protecting industry reputations, VALIDATION
and enhancing personal growth. Since 2001, we have embraced a
singular goal—to provide the highest quality education to life science INSTRUCTOR: RAYMOND MILLER, PH.D.
ADDITIONAL DISCOUNTS professionals. Today, as the global leader in quality life sciences
training, we offer the largest range of course options for professional
Contact us at 610-648-7550 or [email protected] for
information regarding partnership discounts or how your
development in pharmaceutical, medical device, biotech, and skin/ November 13 & 14, 2019 - Boston, MA
cosmetics disciplines. We are dedicated to enriching that reputation by
organization can become a partner with CfPIE. Mar 30 & 31, 2020 - Malvern, PA
conveying content relevant to the needs of individuals and organizations
facing intense scrutiny in those highly technical disciplines.
CANCELLATION POLICY Jul 13 & 14, 2020 - Los Angeles, CA
All cancellations must be in writing and are subject to a Nov 9 & 10, 2020 - Boston, MA
$350.00 cancellation fee. If cancellations are made more than HOW TO REGISTER
30 days prior to the course, a refund less the cancellation
fee will be provided. If cancellations are made less than 30
days prior to the course, a voucher good for attendance at an 1. COURSE DESCRIPTION
upcoming course will be provided. The voucher, which can be This course focuses on developing and implementing
used by the registrant or anyone else within his/her company, Go to http://www.cfpie.com regulated computer systems with an appropriate level of
will be valued at the registration fee minus the $350.00 documented evidence to satisfy FDA expectations. The
cancellation fee. course targets deliverable document content and how to
2. avoid rework and unnecessary expense through a proactive
If a registered attendee does not cancel and fails to attend, approach. The core elements of a satisfactory computer
neither a refund nor voucher will be issued. All course Go to “REGISTER HERE” and select your course. validation program will be emphasized.
cancellations must be in writing and emailed sent to info@
cfpie.com. Registrants are responsible for contacting the hotel 3. Topics to be discussed include:
and canceling their room reservations.
Create an account and register for your course. • The regulatory expectations for computer validation
CFPIE reserves the right to alter the venue, if necessary. • Relevant FDA warning letters
• The tasks and deliverables expected for computer
Substitution Policy - Classroom Courses validation
The Center for Professional Innovation & Education, Inc.
• Why validation processes vary so much
7 Great Valley Parkway • Strategies for practical, yet defensible computer
Substitutions are accepted at no penalty with written
notification from the original registrant in advance of course. Suite 295 validation
All substitution requests must be in writing and emailed to Malvern, Pennsylvania 19355 • Sops required for system operation and maintenance
[email protected]. • 21 CFR part 11 and it’s implications for common
regulations
• An active discussion of part 11 examples and audience
CfPIE also offers on-site courses for 10 or more questions
• The implications of GAMP 5 on computer validation and
attendees. Contact us at [email protected]. how to transition from GAMP 4
http://www.CfPIE.com • Auditing GXP computer systems and suppliers
 INSTRUCTOR CREDENTIALS FIRST DAY SECOND DAY
Dr. Raymond Miller is President of Miller Regulatory Consulting Computer Validation – General Overview Overview of 21 CFR Part 11 (Part 11)
(MRC). His company focuses on compliance management and • Computer Validation fundamentals – a walk-through of a complete • Background and purpose of Part 11
execution in computer system validation and technical validation of a small example system • Overview of Part 11 (review regulation)
services. • Who needs to validate? • Review of the Part 11 implications in regulations and
• What is Computer Validation? guidances:
Prior to founding MRC, Mr. Miller co-founded Cetan • Core principles • 21 CFR Part 58 GLP
Technologies, Inc. There, he served as Vice President and • Brief history of computer validation • ­21 CFR Part 211 GMP
Chief Technical Officer; developing a practical, yet defensible • Why is validation necessary and what regulations guide validation • 21 CFR Part 312 GCP (IND)
approach to computer system validation and 21 CFR Part 11 requirements? • 21 CFR Part 810 QSR
compliance. He also provided primary regulatory oversight and • Review of the computer validation references in regulations and • Guidance: Part 11 scope and application (September
training to consultants, created the firm’s product-development guidances: 2003)
department and developed the first automation-assisted, • 21 CFR Part 211 • Guidance: Computerized Systems Used in Clinical
nonintrusive computer-system validation testing. • 21 CFR Part 810 Investigations
• 21 CFR Part 11 • Guide to the Inspection of Pharmaceutical
In addition to this experience, he has also held senior-level • Annex 11: Computerized Systems Laboratories
computer-validation and information-systems positions with • Guidance: Q7A GMPs for Active Pharmaceutical Ingredients • Review of Part 11-related FDA Warning Letters
AAI, Alcon Labs and Mary Kay Cosmetics. • Guidance: General Principles of Software Validation • Discussion of example systems and the evaluation of Part
• Guidance: Computerized Systems Used in Clinical 11 Compliance decisions
Dr. Miller received both his Ph.D. in Chemical Instrumentation Investigations • Industry trends and approaches – the future of Part 11
and his M.A. in Analytical Chemistry from the University of • When and how are systems validated? issues
Cincinnati. He received his B.S. in Chemistry from Florida • Review of key FDA Warning Letters related to computer validation • Interactive discussion of Part 11 issues and concerns
Atlantic University. (bring your questions)
Computer Validation Process and Deliverables • Achieving and Maintaining Part 11 Compliance
WHO SHOULD ATTEND •
•
What is the SDLC (System Development Life Cycle) process?
How does computer validation fit into the SDLC? GAMP-Specific Computer Validation Topics
This course is designed for Validation, Quality, IT, and Business • What content must be covered? • The industry guidance for Good Automated
personnel responsible for implementing and using regulated • What are the expected tasks and deliverables? Manufacturing Practice (GAMP)
computer systems in the pharmaceutical, biotech and medical • System/software specifications • How GAMP addresses the FDA’s expectations for
device industries. The course is of special value to personnel • Requirements options and documentation computer validation
seeking experience with computer validation and issues • How 21 CFR Part 11 applies to computer validation • GAMP 5 versus GAMP 4
associated with FDA regulated computer systems. The course • Design Qualification (DQ) and vendor selection • How to transition to GAMP 5 from GAMP 4
is especially designed for attendees seeking a thorough • Risk Assessment in computer validation • A review of the supplementary GAMP guidances and
introductory level of understanding, yet is also designed to • Where does it apply? where they apply
be valuable to those with prior experience seeking to remain • A walkthrough of the GAMP risk assessment process
current with industry trends and approaches. • Validation Plans and Master Validation Plans Auditing Computer Systems
• Installation Qualification (IQ) • Auditing GxP computer systems
HOTEL INFORMATION •
• The five topics expected in IQ documents
Operational Qualification (OQ) and Performance Qualification (PQ)
• Auditing suppliers of computer systems for GxP use
• Auditing developers for customized systems
The Hilton LAX, Los Angeles, CA (CfPIE room rate of $167/night if booked 3 weeks • ­Testing strategies and level of detail
in advance of the course date)
• The general process for auditing computer systems
• How much testing is enough? • Variations that can save time and money
The Desmond Hotel & Conference Center, Malvern, PA (CfPIE room rate of $141/
night if booked 3 weeks in advance) • Examples of effective test cases and system errors discovered • Review of an example audit checklist
Club Quarters Hotels, Boston, MA (CfPIE room rate of $255/night if booked 4 • SOPs required for system operation and maintenance • Primary areas of focus (what to look for)
weeks in advance). • How they related to FDA Warning Letters • Examples of audit findings
DoubleTree by Hilton London - Victoria (CfPIE room rate of £199.00/night if • Validation Summary Reportse
booked 4 weeks in advance)
Day 2 wrap-up