< Return to Previous Page
Computerized System
Validation
A TWO-Day COMPREHENSIVE & INTERACTIVE COURSE, CASE
STUDIES & WORKSHOP
Dates Available: December 1-2, 2010
Course Time: 8:30 a.m
- 5:00 p.m. (DAY 1). 8:30 a.m - 5:00 p.m. (DAY 2)
Cost: $885.00 +HST
Location: 200 Consumers
Road, Suite 200, Toronto, Ontario
Receive a Credit toward the Diploma program in Quality
Control & Quality Assurance Diploma Program
Course Overview:
Computerized systems are used extensively to capture,
analyze, store data, report information and to control
equipment and processes in laboratories and manufacturing
facilities. Internal and external audit of pharmaceutical
and biopharmaceutical industry has consistently indicated
a lack of validated computer control in the industry.
Computer validation has become one of the key areas
of strong emphasis for regulatory agencies such as Food
and Drug Administration (FDA-US) and health Canada.
This training course provides participants with the
practical approaches to understanding of the methodology
used to validate a computer-related system. Practical
recommendations on how to increase efficiency and ensure
that validation is performed correctly the first time
are used through the entire course. The concepts introduced
provide a comprehensive framework for validation of
computerized systems and present a logical and practical
approach to the validation of any computerized system
to meet both regulatory concerns and business needs
within the pharmaceutical environment.
Course Outline
- Principles of Computerized System Validation (CSV)
- Regulations (FDA, HPFBI, EU) and how they relate to CSV
- 21 CFR Part 11 and Scope & Application Guidance
- Principles of System Development Life Cycle (SDLC)
- Building a System Inventory
- Validation Planning
- System Specifications (Requirements and Design)
- Risk Assessment
- Vendor Assessments & Audits
- Installation, Operation and Performance Qualifications (IQ, OQ , PQ )
- Test Methodologies
- Process Deviations & Traceability Matrix
- Maintaining the System in a Validated State
- Change Control and Configuration Management
- Disaster Recovery and Business Continuity Plan
- System Retirement
- Legacy Systems - Retrospective Evaluation and Validation
- Network Qualification
- Applying CSV to Various Types of Systems
- Review of FDA issued warning Letters and 483s on CSV
Distinguished Faculty
Mr. David McSweeney
SNC Lavalin Pharma,
Validation Specialist
David McSweeney is a Validation Specialist with SNC Lavalin Pharma and has over 15 years of experience working in the R&D, Validation, and Compliance. His background expertise is in compliance and computer validation. He has worked on computer validation projects for companies such as GSK, Sanofi Aventis, Apotex, MDS, 3M,..His computer validation experience includes process control systems, spreadsheet and database applications, and large IT systems such as LIMS, ERP, and Clinical Database Management Systems. He has worked to establish company frameworks for compliance of computer systems to applicable regulations, including 21 CFR Part 11.
Who Should Attend
This two-day course is valuable for Directors, Managers, Supervisors, Associates in the Pharmaceutical, Biopharmaceutical, Vitamins, Herbals, Medical Devices and allied industries with daily responsibilities in the following areas:
- Regulatory Affairs
- Quality Assurance
- Product Submission
- Training
- Consultants
- Clinical Research
- Documentation and Technical Writing
- Project Management
- Product Development
- Others who interact together to launch a product
Agenda
Day One
8:30am - 9:00am
Registration and Continental Breakfast
9:00am - 9:05am
Opening Remarks
9:05am - 10:45am
Computerized System Validation
10:45am - 11:00am
Mid-Morning Break
11:00am - 12:45pm
Computerized System Validation Cont'd
12:45pm - 1:45pm
Luncheon
1:45pm - 3:30pm
Computerized System Validation Cont'd
3:30pm - 3:45pm
Afternoon Break
3:45pm - 5:00pm
Computerized System Validation
Day Two
8:30am - 9:00am
Continental Breakfast
9:00am - 10:45am
Computerized System Validation Cont'd
10:45am - 11:00am
Mid-Morning Break
11:00am - 12:45pm
Computerized System Validation Cont'd
12:45pm - 1:45pm
Luncheon
1:45pm - 3:30pm
Computerized System Validation Cont'd
3:30pm - 3:45pm
Afternoon Break
3:45pm - 5:00pm
Computerized System Validation
CERTIFICATE OF ATTENDANCE AND COURSE MATERIAL
- All participants will receive a certificate of attendance upon completion of the course.
- The participants will be receiving specially prepared course manual.
COURSE TIME & LOCATION
AAPS Training Center
200 Consumers Road, Suite 200 , Toronto , Ontario , M2J 4R4
tel: 416-502-2277
www.aaps.ca
< Return to Previous Page
|
