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Hi all,
Our company has just released a multimedia training product relating to
Pharmaceutical Validation which some of you may be interested in.
Below is a small introduction however you may view more info or download a
demo version by visiting our web site at http://www.compupharma.net
Thanks for your time,
Anthony.
Anthony Birchall
IT Manager - CompuPharma Ltd.
Quill Road, Kilmacanogue, Co Wicklow, Ireland
http://www.compupharma.net
Understanding Pharmaceutical Validation 3.0
The objective of CompuPharma=92s Validation multimedia software package is t=
o
present Validation in an easy to understand methodology that will assist the
user in setting up their own validation programs. The program is more
technically comprehensive than the information that is contained in the
regulators guidelines and identifies all the critical process parameters
that need to be controlled and specifies the experimental measurements that
should be used. It also gives a technical introduction for all the major
sections within the package. This is important to new personnel who must
understand the theory of the process before any validation protocol can be
written.
Designed by the Industry for the Industry
The software is specifically designed so various levels of personnel can use
it effectively and with benefit. It will be an ideal training aid to new
personnel working in validation. It can also help more experienced
validation scientists learn about the many manufacturing areas that must be
validated. Operators who want to understand the theory and practice of the
individual processes should also find this package very worthwhile.
Contents
Some of the topics included in the program are:
a.. Concepts of Validation
b.. Documentation
c.. Barr Report
d.. Documentation Structure
e.. Regulatory Information
f.. Organising a programme
g.. Validation Protocols
h.. Aseptic Processing
i.. Equipment
j.. Cleanroom Utilities
k.. Media Fills
l.. Process Validation
m.. Isolator Technology
n.. Manufacturing
o.. Computerised Systems
p.. Production Processes
q.. Cleaning
r.. Finishing Processes
s.. Utilities
t.. Analytical Methods
u.. LIMS
v.. Regulations
w.. Validation
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David Bourne (david@boomer.org)