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DTSTAMP:20240329T001523Z
UID:d7f49fc7-5fb7-4852-8efc-3af0ed9c9681
DTSTART:20211014T083000
DTEND:20211015T083000
CLASS:PRIVATE
DESCRIPTION:
Overview
\n\n\n - This interactive two-day course explores
proven techniques for reducing costs associated with implementing\, using
\, and maintaining computer systems in regulated environments.
\n - Many
companies are outsourcing IT resources and getting involved with Software
as a Service (SaaS) and cloud computing. These vendors are not regulated
and therefore regulated companies must ensure compliance for both infrastr
ucture qualification and computer system validation. It is the regulated c
ompany that wants to avoid FDA form 483s and warning letters. The seminar
is intended for regulated companies\, software vendors\, and SaaS/Cloud pr
oviders.
\n - The instructor addresses the latest computer system indust
ry standards for data security\, data transfer\, audit trails\, electronic
records and signatures\, software validation\, and computer system valida
tion.
\n - Today the FDA performs both GxP and Part 11 inspections\, the
Europeans have released an updated Annex 11 regulation that expands Part
11 requirements and companies must update their systems and processes to m
aintain compliance.
\n - This seminar will help you understand the speci
fic requirements associated with local and SaaS/cloud hosting solutions.
span>
\n - Nearly every computerized system used in laboratory\, clinical\, man
ufacturing settings and in the quality process has to be validated.
\n - Participants learn how to decrease software implementation times and lowe
r costs using a 10-step risk-based approach to computer system validation.
\n - Finally\, the instructor reviews recent FDA inspection trends and
discusses how to streamline document authoring\, revision\, review\, and a
pproval.
\n - This course benefits anyone that uses computer systems to
perform their job functions and is ideal for regulatory\, clinical\, and I
T professionals working in the health care\, clinical trial\, biopharmaceu
tical\, and medical device sectors. It is essential for software vendors\,
auditors\, and quality staff involved in GxP applications.
\n<
/ul>\n\n \;\n
Course Objectives:
\n\
n
\n - Understand what is expected in Par
t 11 and Annex 11 inspections
\n - Avoid 483 and Warning Letters<
/li>\n
-
Learn how to buy COTS software and qualify vendors.
\n - Implement a com
puter system using risk-based validation to gain maximum productivity and
reduce cost by as much as two thirds
\n - Requirements for local\, SaaS\
, and cloud hosting
\n - How to select resources and manage validation p
rojects
\n - "\;Right size"\; change control methods that allows
quick and safe system evolution
\n - Minimize the validation documentat
ion to reduce costs without increasing regulatory or business risk<
/li>\n
-
Write test cases that trace to elements of risk management
\n <
li style="box-sizing: border-box\;">Protect
intellectual property and keep electronic records safe\n
\
n\n
\n
<
span style="color:#000000\;">Who will benefit:
\n\n
\n - QA\, IT\, management
\n - all GxP system user
s
\n
\n
===
\nPlease cont
act the event manager Marilyn below for the following:
\n- Discounts
for registering 5 or more participants.
\n- If you company requires a
price quotation.
\n- For event ticket\, contact +1 929 900 1853
\nEvent Manager Contact: marilyn.b.turner(at)nyeventslist.com
\nYou
can also contact us if you require a visa invitation letter\, after ticket
purchase.
\nWe can also provide a certificate of completion for this
event if required.
\n \;
\nNO REFUNDS OR TRANSFER ALLOWED O
N REGISTRATIONS
\n---------------------------------------------------
--------------
\nThis Event Listing is Promoted \; by
\nNew
York Media Technologies LLC in association
\nwith GlobalCompliancePan
el.\n
http://www.NyEvent
sList.com\n
http://www.
BostonEventsList.com\n
h
ttp://www.SFBayEventsList.com\n---------------------------------
--------------------------------
\n \;
\n
\n
SUMMARY:21 CFR Part 11 compliance for software validation and SaaS/Cloud
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SUMMARY:21 CFR Part 11 compliance for software validation and SaaS/Cloud
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