The No. 1 Trade Show Site in the U.S.

Menu
×
EVENT DATE
May 2017
M T W T F S S
08091011121314
EXPO DATE
May 2017
M T W T F S S
08091011121314

Venue

Pyramid Club 1735 Market Street BNY Mellon Center - 52nd Floor
Philadelphia , PA 19103
Location map
Type: Indoor - Hotel

HOTEL DEALS

Booking.com

TRAVEL DEALS

Expedia.com

Partners

exhibitus success by design Remington Hotels

21 CFR Part 11 Compliance For SaaS/Cloud Applications

Pyramid Club
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.

Learning Objectives:

  • Understand what is expected in Part 11 and Annex 11 inspections
  • Avoid 483s and Warning Letters
  • Learn how to buy COTS software and qualify vendors
  • Implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds
  • Requirements for local, SaaS, and cloud hosting
  • How to select resources and manage validation projects
  • "Right size" change control methods that allows quick and safe system evolution
  • Minimize the validation documentation to reduce costs without increasing regulatory or business risk
  • Write test cases that trace to elements of risk management
  • Protect intellectual property and keep electronic records safe

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

Don't wait to register for the 21 CFR Part 11 Compliance For SaaS/Cloud Applications. You'll meet influential people and maximize your opportunities for success. Start now by accessing the information below.

EVENT CONTACTS

Sign Up for FULL Membership and Log In to access Event Contact Information.

EVENT DETAILS

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

Exhibitor Information +

Booth Details:

Booth Size
Booth Cost
Call for information.
Amenities
Electricity:
n/a
Water:
n/a
Generator:
n/a
Marketing Vehicles Allowed:
Call
Services
n/a
Show Owner
ComplianceOnline

floor plan

MORE events +

BUSINESS+
HEALTH CARE+
MANUFACTURING+
TECHNOLOGY+

Display Makers

Promo Makers

2017: 2,575 Trade Shows
2018: 575 Trade Shows
© copyright since 2008 All Rights Reserved eventsinamerica.com
986
page views