Data Integrity: Learn to Comply with the FDA Expectations and Avoid Facing Penalties ranging

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.

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. 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

Industries:

Pharmaceuticals
Biotech
Medical Device
Radiological Health
Blood Products
Companion Animals
Food
Cosmetics
Tobacco
Academia

Agenda:

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

Speaker

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

Venue:  WILL BE ANNOUNCED SOON

Price:

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

[email protected]  

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Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

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