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EVENT DATE
Sep 2017
M T W T F S S
252627282930
EXPO DATE
Sep 2017
M T W T F S S
252627282930

Venue

Venue TBD
Sao Paulo 18090
Brazil
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21 CFR (Code Of Federal Regulations) Part 11 Compliance For Software Validation And SaaS (Software As A Service) / Cloud

Venue TBD
B2B 30

EVENT DESCRIPTION

This two-day interactive course explores proven techniques to reduce costs associated with implementing, using and maintaining computer systems in regulated environments.

Many companies are outsourcing IT resources and are getting involved with Software as a Service (SaaS) and Cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for infrastructure qualification and for computer system validation. It is the regulated company that wants to avoid FDA Form 483 (Food and Drug Administration) and warning letters. The seminar is for regulated companies, software vendors and SaaS / Cloud providers.

The instructor explains the latest standards in the computer systems industry for data security, data transfer, audit trails, electronic signatures and registrations, software validation, and validation of computer systems. 
Today, FDA performs GXP (good practice) and Part 11 inspections. Europeans have issued an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.

This seminar will help you understand the specific requirements associated with local and SaaS / Cloud hosting solutions. 
Almost all computerized systems that are used in laboratories, clinics, manufacturing scenarios and in the quality process have to be validated.

Participants learn how to shorten software deployment times and reduce costs by using a 10-step risk-based approach to computer system validation. 
Finally, the instructor re-evaluates recent FDA inspection trends and explains how to simplify document creation, review, and approval.

This course benefits anyone who uses computer systems to perform their job functions and is ideal for administrative, clinical, and IT professionals working in the healthcare, clinical, biopharmaceutical and medical device sectors. It is essential for software vendors, auditors, and quality personnel involved in GxP (best practices) applications.

Note: Use coupon code REFERRAL10 and get 10% off on registration.

For Registration:

http://www.complianceonline.com/21-cfr-parte-11-conformidade-para-valida%C3%A7%C3%A3o-de-software-e-saas-cloud-applications-brazil-seminar-training-80484SEM-prdsm?channel=eventsinamerica

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EVENT DETAILS

Primary Industry:
IT
Other Industries:
IT, Technology
Audience:
This course will benefit everyone who uses computer systems to perform their job duties and is ideal for regulatory, clinical and IT professionals working in the healthcare, clinical, biopharmaceutical and medical device industries. It is essential for software vendors, auditors and quality personnel involved in GxP applications.
QA (quality assurance)
IT, management
All users of the GxP system
Regulatory Affairs
Software Managers
Project Managers
Suppliers and software vendors
Notes:
Show Owner:
ComplianceOnline
Sponsorship:

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ComplianceOnline

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