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The CSV Workshop has an approximately
17 hours of direct contact. This Workshop consist of the discussion
of 21CFR Part 11 and the NEW Guide to for ISPE Validation of Automated
Systems (GAMP 5) which the FDA current recommended guide for validation
of automated systems.
Discussion Topics:
- 21 CFR Part 11 and Computer Systems Validation Overview:
- Development and Validation Activities
- Terminology, Acronyms and Definitions
- Maintaining a Validated State
- Process Control System Validation. Aspects covered:
- Validation Life Cycle Models
- Types of Process Control Systems
- Specification and Design
- Design Review
- Software Review
- Supplier Development & Acceptance Testing
- Instrument Inspection and Calibration
- Validation Planing activities
- Supplier Audit Validation Some topics to be covered are:
- When they are required?
- Types of Audits
- Risk Assessment Methodology
- Categories of Software and Hardware
- Design Review and Requirements for Traceability Matrix
- Guideline for Validation Reporting
- Guideline for Project Change Control, Configuration Management
and Document management
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- Sample Procedures for creation of
- User Requirement Specification
- Functional Specification
- lHardware Design Specification
- Software Design Specification
- Guidelines for Testing of an Automated System
- Guidelines for Periodic Review
- Guidelines for System Security
- Guideline for Record Retention Archiving and Retrieval
- Guideline for Backup and Recovery of Software and Data.
- General Methodology and Documentation Development Techniques
- Live Workshop CSV examples and exercises.
What you get is what you need:
(1) Learn the latest and most useful information from
active consultants in the Regulated Industry - you will learn the
do's and don't to be successful, even interview and resume tips.
(2) Small groups - Courses are easier to follow, you will get
the attention you need and your questions will be answered.
(3) Advanced Active Learning Methods - You will view professional
made PowerPointŪ presentations that include equipment, processes
diagrams and images.
(4) Experience group discussions and real industry validation applications
and situations.
(5) We will provide with a cGMP's booklet, Regulatory reference
information & access to our reference documentation database.
Partial Payment
Method!! PVSR
provides now a Payment Option which consists of the split
of the total cost of the workshop or workshops that you will take
over a three (3) month period. Please download the application form
and agreement and send it by fax to 787 807 FAX0 (3290) for
evaluation.
Payment Option Form (PDF)
Payment Option Form (Word) |
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COMPUTER
SYSTEM
VALIDATION
WORKSHOP
ONLY $699
(Spaces are limited)
Saturday
Course (Two days) From 8:30am TO 6:00PM
Reservations:
You can reserve your space now (available 24 hours) in our Fully
Automated Electronic Reservation and Payment System (all mayor
Credit cards accepted).
Go
to our secured site to view dates available and to make your reservation
Open
On-line Fill-in printable Fax Form & Questionare
Download
Fax Request Form (The approval of this fax request will depend on
Course (s) availability) -
use this one if prior link does not work!
(Fax reservations will be confirmed by phone)
QUESTIONS?
contactus@pvsrwebsite.com
CALL US 787 807 PVSR (7877)
CALL US 787 807 PV00 (7800)
FAX US 787 807 FAX0 (3290)
About the Course Training
Leader
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