Computerized Systems Auditing and Software Validation
Management Strategies to meet Regulatory
Compliance
Quality Assurance, Risk Management, and Regulatory
Compliance for Pharmaceutical and Healthcare Manufacturers
A TWO DAY COMPREHENSIVE & INTERACTIVE COURSE,
WITH CASE STUDIES & WORKSHOPS ON:
- Regulatory Expectations for Computer System
GxP Compliance
- Preparing for an FDA Inspection and Review
of Common 483’s
- Requirements for a Successful Validation
Project
- Software Validation Methods, Design, Development,
Verification
- Performing IQ/PQ/OQ Requirements and Documentation
- Validation for Off the Shelf (OTS) Software
and Custom Programs
- Achieving Traceability in the Validation
Process
- Meeting User Requirement Specifications (URS)
- Applying Risk Management and Risk Based Approach
- Change and Configuration Management Procedures
- Prioritization of Systems and System Maintenance
Procedus
- Managing Spreadsheets, Production and Lab
Equipment
- System-Level Validation Testing
- System Maintenance for Security
- Traceability and Archiving
- Strategies for Vendor Auditing
- Documentation Management
Interactive Sessions:
- Performing a Self Audit of GxP Computer Systems
- User Requirement Specifications (USR) Evaluation
- Validation for Laboratory Information Management
Systems (LIMS)
Distinguished Program Presenters:
Mr. Marc Monette
President,
Compliance Management Systems
Marc Monette, President Compliance Management
Systems, Inc. is a Subject Matter Expert (SME)
on Computerized System Validation (CSV), System
Development Life Cycle (SDLC, now SLC per GAMP
5) modeling, and on the development of risk
based and scalable validation programs that
facilitate right-sizing the validation effort.
He is a competent trainer who addresses hundreds
of men and women each year on System Life Cycle
(SLC) modeling, CSV and SLC program development,
audit effectiveness, remediation planning, and
cost of quality.
Marc has acquired over 20 years of experience
in pharmaceutical, biotechnology, medical device,
and other regulated industries. He has traveled
in the US, Canada, Europe and Asia consulting
with large and small organizations, educating,
and training professionals from many life sciences
organizations. Marc is an American Society for
Quality Certified Software Quality Engineer,
Certified Quality Auditor, and Certified Quality
Manager.
Marc initiated his lifelong learning habits
by achieving a BESc Degree from the University
of Western Ontario, an MBA degree from University
of Toronto, and is currently working on his
thesis to complete the Master of Science Regulatory
Affairs (MSRA) degree at San Diego State University.
As a consultant, he has drawn on the expertise
of many others in the field and has taught many
industry professionals the keys to success in
this dynamic and exciting field.
Dr. Richard G.
Poser
Principal Consultant
First Quality Group
Rich Poser, Ph.D. obtained his Masters and
Doctorate degrees in Medical Sciences at New
York University Medical, Graduate School of
Arts & Science in his home town of New York
City. His graduate research in Experimental
Pathology focused on developing non-toxic chemotherapy
for malignant melanoma, and preventing neural
trauma following stroke or impact injuries.
He was awarded a US Public Health Service Fellowship
to develop less toxic cancer chemotherapies
at the prestigious Memorial Sloan-Kettering
Cancer Center.
In 1981 he joined the A.H. Robins Company in
Richmond, VA, where he invented transdermal
drug delivery system. In support of this project,
he developed automated and robotic systems for
sampling and analyzing biological tissues. It
was here, under the first regulations for validating
computer systems used in animal toxicology testing,
that Rich began his focus on computer system
validation. In 1987 he became Director of Analytical
Science at the Fisons Pharmaceuticals site in
Rochester, NY. Fisons is a British firm, and
in 1991 he was appointed Director of Information
Systems to design, validate and implement one
of the first international Document Management
Systems for computer-assisted assembly of NDAs
– a so-called CANDA system. Following work in
laboratory automation and quality systems for
the Mylan Pharmaceutical Company, and a few
years in private consulting, Rich came to San
Diego with his wife and daughters in 1996 to
join Dura Pharmaceuticals. He held positions
as Director in Product Development, Quality
Laboratory Operations and R&D Quality Assurance.
Following acquisition of Dura by Élan, Rich
was part of their global computer system validation
training and implementation team. Following
the site closing of the drug development effort
in 2001, Rich continued his training and validation
passions as a corporate consultant. He also
lectures at SDSU and UCSD Extension programs
in computer validation, cGMP Regulations and
analytical methods validation.
Today Rich Poser is Principal Consultant for
First Quality Group, a consulting practice focused
on Quality Systems, Training and Validation.
Their clients include biotechnology, pharmaceutical
and medical device firms, as well as the vendors
and software developers that support these highly
regulated industries.
Program Agenda
| Day 1 |
|
Monday, September
22nd, 2008 |
| 8:00 AM |
|
Registration and
Continental Breakfast |
| 8:30 AM |
|
Course Begins |
| 10:15 AM |
|
Mid-Morning Refreshment
Break |
| 12:00 PM |
|
Luncheon |
| 1:15 PM |
|
Course Continues |
| 2:45 PM |
|
Mid-Afternoon Refreshment |
| 4:15 PM |
|
Questions & Answers |
| 4:30 PM |
|
Conclusion of Day
One |
|
|
|
| Day 2 |
|
Tuesday, September
23rd, 2008 |
| 8:00 AM |
|
Continental Breakfast |
| 8:30 AM |
|
Course Continues |
| 10:15 AM |
|
Mid-Morning Refreshment
Break |
| 12:00 PM |
|
Luncheon |
| 1:00 PM |
|
Course Continues |
| 2:30 PM |
|
Questions & Answers |
| 2:45 PM |
|
Conclusion of Day
2 |
Program Content:
| Day 1 |
|
Monday, September
22nd, 2008 |
| |
|
8:30 AM - 4:30 PM |
| |
|
Computer and Software
Validation Requirements for GxP
- Regulatory Expectations
- CFR Part 11 - Electronic Records and
Signatures
- Legacy Systems and Part 11 Compliance
- Predicate Rules
- Data Security and Integrity
- Archiving
- Changes in Part 11 interpretation and
enforcement
Overview of the System Development LifeCycle
(SDLC)
- Components
- Incorporating the entire validation
life cycle
- Development of a Site Master Validation
Plan
- Development of a Project Master Validation
Plan
- Validation Protocol
- Documentation requirements for IQ/OQ/PQ
- Validation Report
- Establishing System Maintenance procedures
such as
- Change Control
- Training
- Security
|
| |
|
Applying Risk Based
Approach and Risk Management of your GxP
Computer System
- System Classification
- Risk Based Approach to Validating Networks
- System Risk Assessment
- Functional Risk Assessment
- Change Control Impact Assessment
- Managing potential threats
- Applying technologies to ensure consistent
security management of critical systems
- Complying with FDA requirements when
using a risk-based approach.
Case Study Discussion :
Preparing for an FDA Inspection of Computerized
Systems
- Common 483s and FDA findings during
inspections and audits
|
| |
|
Workshop:
How to Plan a Self Audit of your GxP Computer
Systems
- Part 11 assessment - Requirements that
meet the needs of the business
- Assessment of Systems
- Preparing Audit Checklist
- Prioritization of Systems
How to Audit Software Vendors
- SOPs for Vendor Audits
- Forms and Questionnaires
- User Requirement Specifications (URS)
Developing an Audit Checklist |
| |
|
Questions and Answers
|
|
|
|
| Day 2 |
|
Tuesday, September
23rd, 2008 |
| |
|
8:30 AM - 2:45 PM |
| |
|
Software Validation
Methods, Design, Development
& Verification
Project Management Strategies
- Requirements for a successful validation
project
- Business, user, regulatory, and IT
representation
- A sound validation strategy
- Planning for technology issues
Implementation
- Validation report
- System SOPs
- User training and system deployment
Validating Custom Programs
- User Requirements
- System Specifications
- Development Documentation
- Integration Testing
Validation Requirements of Off the Shelf
(OTS) Software including:
- System specifications
- IQ/OQ/PQ requirements
Validation Requirements of Other Types
of Projects
- Spreadsheets
- Production Equipment
- Lab Equipment
- Network Qualification
Maintaining the Qualified State
- Administration and maintenance procedures
- Change and configuration management
procedures
System Level Validation Testing
Traceability in the Validation Process
|
| |
|
Interactive Workshop
and Discussion:
User Requirement Specifications (URS)
- Key Deliverable for Success
Conformance to User's Requirements
- Overview of where the User's Specification
fits in the process of validation
- Figuring out how URS meshes with other
validation documentation, i.e. Computer
Validation Plan and the Risk Assessment
- Building a validation data package
that will deliver a system with a low
cost of ownership and will more than meet
FDA regulations
A Risk-Based Approach
- Validation testing and applying the
principles of the risk-based validation
test planning
- Determining the role of the URS
- Developing requirements for efficient
validation planning
- Understanding the V-Model and how it
fits in validation planning
- How does your URS line up with the
succeeding deliverables particularly the
FRS?
- Using your URS to select a vendor
Interactive Exercise:
|
| |
|
Interactive Workshop
and Discussion:
Validating a Laboratory Information Management
Systems (LIMS)
- Practical strategies to develop a validation
master plan, validating existing systems
and prepare for inspections
- Change management strategies of existing
and upgraded systems, validation of hardware
and software and revalidation
- Risk considerations- the LIMS system
- Compliance of data management within
the RD and QC laboratory- its relevance
to CFR Part 11
- Validation and Laboratory Data Archiving
Challenges
- Cost-effective ways to upgrade your
knowledge in validation and regulatory
requirements for LIMS
Improving your Validation Master Plan
(VMP)
- IQ/PQ/OQ Test Plans
- Validation Summary Reports
|
| |
|
Questions and Answers |
Who Should Attend:
This two day seminar and workshops program is
directed toward Directors, Managers, Supervisors,
Analysts, and Associates in the Pharmaceutical,
Biopharmaceutical, Medical Device, and allied
industries with responsibilities in
- Computer and Software Validation
- Validation
- Compliance
- Quality Assurance
- Quality Control
- Information Technology
- Systems Engineering
- System Users
- Computer Programming
- Electronic Documentation
- Electronic Data Management
- Auditing
- Vendor Management
- Regulatory Affairs
- Technical Writing
- Training
Registration Information:
Registration Fee: $875.00 +
GST
Online Registration
Payment Information Hotel
Accommodations
Course Location:
200 Consumers Road, Suite 200
North York, Ontario
M2J 4R4 Canada
Map
Registration Fee Includes:
Presentation Materials, Luncheon, and Refreshments
Cancellation/Substitutions
Policy:
CANCELLATION POLICY:
Cancellation is accepted in writing (by mail,
or fax) up to 4 weeks before the program start
date, after which cancellations are not accepted
and do not qualify for refund or credit. All Cancellations
are subject to a $210.00 CAD (incl. GST)/person
processing fee. Substitution of delegate/s with
the member/s of the same organization is permitted
at any time. IPA reserves the right to postpone
an event, prior to which time all the registered
attendees will be notified a minimum of 2 weeks
in advance. IPA shall not be responsible for any
air fare, hotel or transportation costs incurred
by registrant/s.
Certificate of Attendance:
All participants will receive a certificate of attendance
upon completion of the course
For registration or any further
information, please contact us at:
Tel: (416) 410-7402
Fax: (416) 491-5810
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