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Computer System Validation - Reduce Costs and Avoid 483s: 2-day In-person Seminar

ComplianceOnline

Thursday, February 6, 2014 at 8:30 AM - Friday, February 7, 2014 at 4:30 PM (PST)

Scottsdale, AZ

Computer System Validation - Reduce Costs and Avoid 483s:...

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Online Ticket 20 Tickets Ended $1,599.00 $57.92

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Course Description:

Significant changes in the regulations and industry standards for software validation are detailed in this interactive two-day course. The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation related to FDA 21 CFR Part 11, European Annex 11, and HIPAA electronic security regulations for patient medical records.

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.

Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated. Finding efficiencies without weakening the quality position is essential. This explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Students learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation. Finally, the instructor reviews recent FDA inspection trends and discusses how to streamline SOP authoring, revision, review, and approval.

This course benefits anyone that uses 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.


Learning Objective:

  • Understand what is expected in Part 11 and Annex 11 inspections
  • Implement a computer system to gain maximum productivity and reduce cost by as much as two thirds
  • Quickly cross train workers and see how to make use of temporary workers and outsourcing to promote growth and reduce costs
  • "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 benefits anyone that uses 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.

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

For Registration:http://www.complianceonline.com/ecommerce/control/seminar?product_id=80005SEM&?channel=eventbrite

Have questions about Computer System Validation - Reduce Costs and Avoid 483s: 2-day In-person Seminar? Contact ComplianceOnline

When & Where



Scottsdale Marriott Suites Old Town
7325 E 3rd Ave
Scottsdale, AZ 85251

Thursday, February 6, 2014 at 8:30 AM - Friday, February 7, 2014 at 4:30 PM (PST)


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Organizer

ComplianceOnline

At ComplianceOnline, we are focused on :

 

  • Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
  • Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
  • Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
  • Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

 

 

 

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