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EVENT DATE
Jun 2017
M T W T F S S
12131415161718
EXPO DATE
Jun 2017
M T W T F S S
12131415161718

Venue

DoubleTree by Hilton Hotel San Diego Downtown 1646 Front Street
San Diego , CA 92101
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Type: Indoor - Hotel

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21 CFR Part 11 Compliance For SaaS/Cloud Applications

DoubleTree by Hilton Hotel San Diego Downtown
B2B 30

EVENT DESCRIPTION

This interactive two-day course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. 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 maintain compliance.

Many companies outsource IT resources and are involved in Software as a Service (SaaS) and cloud computing. These vendors are not regulated, and therefore, regulated companies must ensure compliance for both infrastructure qualification and computer system validation to avoid FDA form 483s and Warning Letters.

This course is intended for these regulated companies, software vendors, and SaaS/cloud providers. The seminar instructor will:

  • Address the latest computer system industry standards for data security,data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.
  • Help participants understand the specific requirements associated with local and SaaS/cloud hosting solutions.
  • Illustrate the importance of validating the quality process and every computerized system used in laboratory, clinical, and manufacturing settings.
  • Demonstrate how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation.
  • Review recent FDA inspection trends and discuss how to streamline document authoring, revision, review, and approval.

 

Who will Benefit:

This course will benefit all who use computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications.

  • Regulatory Affairs
  • QA/ QC
  • IT/IS
  • Software Managers
  • Project Managers
  • Software vendors and suppliers

 

Note:
Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/21-cfr-part-11-compliance-for-saas-cloud-applications-seminar-training-80202SEM-prdsm?channel=eventsinamerica

If the 21 CFR Part 11 Compliance For SaaS/Cloud Applications is important to your business, act now and make the appropriate connections. See the contact information below.

EVENT CONTACTS

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EVENT DETAILS

Primary Industry:
Software
Other Industries:
IT, Software, Technology
Audience:
Regulatory Affairs
QA/ QC
IT/IS
Software Managers
Project Managers
Software vendors and suppliers
Notes:
Show Owner:
ComplianceOnline
Sponsorship:

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Show Owner
ComplianceOnline

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