GAMP Guidelines and Managing Risk to Record and Data Integrity 2018

  • Check with publisher
  • Published date: March 6, 2018
    • SFO, California, United States

Overview:
The impact of Data Integrity issues on a regulated company can be significant: it can result in recalls of products, warning or untitled letters, import alerts, injunctions, seizures, legal action, etc. These regulatory actions can have significant financial impact to the company. However, and most importantly, data integrity issues can lead to potential patient harm!!
Defined by the Medicines and Healthcare Products Regulatory Agency (MHRA) as "the extent which all data are complete, consistent and accurate throughout the data lifecycle", data integrity is increasingly the focus of regulatory agencies round the world. Companies must now ensure that they are appropriately addressing data integrity and data governance. This includes organizational, procedural and technical controls that must be considered as part of an overarching data governance system. In addition, the effort and resources committed to data integrity must be commensurate with the role it plays in assuring product quality.
To ensure Data Integrity, a GxP regulated company needs to abide by principles, current regulations and industry best practices on the expectations for the management GxP regulated records and data. These principles, regulations and best practices, ensure that data is complete, consistent, accurate, secure and available throughout the record life cycle. This approach is intended to encourage innovation and technological advances while avoiding unacceptable risk to product quality, patient safety and public health.
Key implementation considerations for a corporate data integrity program, include development of a high-level strategy, identifying and gaining executive sponsorship, focusing on management accountability, implementing tools for knowledge sharing and developing and providing the appropriate levels of training. An effective data integrity program includes addressing of behavioral factors and drives a strategy that focuses on prevention, detection, response and continuous improvement.
The Seminar
This Seminar addresses the integrity of GxP records and data used within the regulated industries including pharmaceutical, biological, medical devices, cosmetics, food and any other industry where data integrity is important. It provides a method for managing risk to record and data integrity. Learning Objectives for the seminar include:
1. Data Integrity Requirements
2. Critical Areas of Regulatory Focus and Concern
3. Key Concepts
4. A Framework for Data Governance and Human Factors
5. A Complete Data Life Cycle Approach as Part of a Quality Management System, from Creation to Destruction
6. How to Apply Risk Management to Data Integrity
Why you should attend:
• VP of IT
• Director of IT
• Quality Managers
• Project Managers (for CSV / IT)
• Validation Specialists
• Database Administrators
• System Administrators
• Directors / Senior Directors of Discovery
• Directors / Senior Directors of Development
• Directors / Senior Directors of Commercialization
• Document Managers
• Training Managers
• Regulators
• Vendors
• Suppliers
• Outsource Service Providers
Industries
• Pharmaceuticals
• Biotech
• Medical Device
• Radiological Health
• Blood Products
• Companion Animals
• Food
• Cosmetics
• Tobacco
• Academia
Location: Seattle, WA
Date: April 9th & 10th, 2018
Time: 9:00 AM to 6:00 PM
Venue: WILL BE ANNOUNCED SOON
Price:
Price: $1,995.00 (Seminar Fee for One Delegate)
Register for 5 attendees Price: $5,985.00 $9,975.00 You Save: $3,990.00 (40%)*
Register for 10 attendees Price: $10,972.00 $19,950.00 You Save: $8,978.00 (45%)*
Register now and save $200. (Early Bird)
Until March 20, Early Bird Price: $1,995.00 From March 21 to April 07, Regular Price: $2,195.00
Contact us today!
NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
support@globalcompliancepanel.com
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com

Registration Link - Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901684SEMINAR?april-2018-seo-science-marketplace.org
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