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Data Integrity: Learn to Comply with the FDA Expectations and Avoid Facing Penalties ranging from Public Warning Letters to Criminal Charges and Product Removal from the Market Place

Du Jeudi 23 Août 2018 au Vendredi 24 Août 2018 à PA
A partir de: 09:00
Secteurs concernés: Informatique médical -
Course "Data Integrity: Learn to Comply with the FDA Expectations and Avoid Facing Penalties ranging from Public Warning Letters to Criminal Charges and Product Removal from the Market Place" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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. This includes organizational, procedural and technical controls that must be considered as part of an overarching data integrity 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:
• data integrity Requirements
• Critical Areas of Regulatory Focus and Concern
• Key Concepts
• A Framework for data integrity and Human Factors
• A Complete Data Life Cycle Approach as Part of a Quality Management System, from Creation to Destruction
• How to Apply Risk Management to data integrity
Who 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
• Pharmaceuticals
• Biotech
• Medical Device
• Radiological Health
• Blood Products
• Companion Animals
• Food
• Cosmetics
• Tobacco
• Academia
Day 1 Schedule
Lecture 1:
Introduction and Background
• Introductions / Participants' Understanding / Participants' Objectives for the Course (Please come prepared to discuss)
• Regulatory Focus
• Data Integrity Requirements
Lecture 2:
Data Integrity Framework
• Elements of the Data Integrity Framework
• Human Factors in Data Integrity
• Data Integrity Maturity Model
Lecture 3:
Quality Risk Management
• Process Risk Management
• Quality Risk Management
• Product and Process Context
Lecture 4:
Data Life Cycle
• Data Creation
• Data Processing
• Data Review, Reporting and Use
• Data Retention & Retrieval
• Data Destruction
• Integrating Data Integrity into Existing Records Management Process

Day 2 Schedule
Lecture 5:
Data Integrity Management
• Corporate Data Integrity Program
• Data Integrity Maturity Model
• Human Factors
• Inspection Readiness
Lecture 6:
Auditing & Audit Trails
• Data Audit Trail
• Audit Trail Review
• Data Auditing
• Periodic Review
Lecture 7:
Data Integrity for Electronic Records / Electronic Signatures (ERES)
• User Requirements
• Process Mapping & Interfaces
• Controls for Electronic Records / Electronic Signatures
• Data Integrity for Spreadsheets & End-User Applications
• Data Integrity for IT Infrastructure
Lecture 8:
Data Conversions
• Retention, Archiving & Migration
• Paper Records & Hybrid Situations
• Converting Electronic to Alternative Format or Alternative Format Hybrids
Quiz: Jeopardy!!!!
• Data Integrity
Angela Bazigos
CEO, Touchstone Technologies
Silicon Valley Seasoned Executive with 40 years of experience in the Life Sciences & Healthcare Industries. Positions include Chief Compliance Officer http://morflearning.com/angelabazigos/. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers.
Location:  Philadelphia, PA Date: August 23rd & 24th, 2018 and Time: 9:00 AM to 6:00 PM

Price: $1,295.00 (Seminar Fee for One Delegate)
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*
Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*
Register now and save $200. (Early Bird)
Until July 20, Early Bird Price: $1,295.00 From July 21 to August 22, Regular Price: $1,495.00
Sponsorship Program benefits for seminar
For More Information- https://www.globalcompliancepanel.com/control/sponsorship 
Contact us today!
NetZealous LLC DBA GlobalCompliancePanel
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com

Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901870SEMINAR?SEO
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Accréditations : 0
Public concerné: Professionnel
Audience: Régionale
Visiteurs/Participants: 50
Conférenciers: 1
Exposants: n.r
Type d'événement: Conférence / Séminaire
Secteurs concernés: Informatique médical -

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Congrès, formations ou conférences médicales REF #28-8216
Data Integrity: Learn to Comply with the FDA Expectations and Avoid Facing Penalties ranging from Public Warning Letters to Criminal Charges and Product Removal from the Market Place
Publié sur congres-medical.com le : 2018-07-20 13:03:54
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