Masters program in Data Integrity for IT & Compliance Managers


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Masters Certification program in Data Integrity for IT & Compliance Managers

Duration: 8Hrs  (4Hrs./Day)              

No of modules: 8 modules (4 Modules/Day)

Dates

·     15th April @11AM EST, 

·     16th April @11AM EST

Mode of delivery: Online

PL CEU: 0.8


Course Description

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. 

Topic

Delivery mode

Presented By

Date

Time

Duration

Module 1:

Introduction & Background

Live class

CW Expert

April 15th 2021

11.00 AM ET

1 Hour

Module 2:

Regulatory Requirements

Live class

CW Expert

April 15th 2021

11.00 AM ET

1 Hour

Module 3:

Quality Risk Management

Live class

CW Expert

April 15th 2021

11.00 AM ET

1 Hour

Module 4:

Data LifeCycle

Live class

CW Expert

April 15th 2021

11.00 AM ET

1 Hour

Module 5:

Data Integrity Management

Live class

CW Expert

April 16th 2021

11.00 AM ET

1 Hour

Module 6:

Auditing & Audit Trails

Live class

CW Expert

April 16th 2021

11.00 AM ET

1 Hour

Module 7:

Data Conversions

Live class

CW Expert

April 16th 2021

11.00 AM ET

1 Hour

Module 8:

 Data Integrity & Final Thoughts

Live class

CW Expert

April 16th 2021

11.00 AM ET

1 Hour

Who will benefit:           

·         VP of IT

·         Director of IT

·         Quality Managers

·         Project Managers (for DATA INTEGRITY / IT)

·         Validation Managers

·         Database Administration Managers

·         System Administration Managers

·         Directors / Senior Directors of Discovery

·         Directors / Senior Directors of Development

·         Directors / Senior Directors of Commercialization

·         Document Managers

·         Training Managers

·         Consultants

·         Data Managers

·         Safety Managers

Program Features:

1.       Online course delivery – Live instructor-led training delivered by top industry expert

2.       Q&A after every session

3.       Unlimited access to learning videos in case you miss the live classroom session

4.       Soft copy of learning materials

5.       Assessment at the end of the course; CCU certificate upon successful completion

6.       Lifetime access to the learning platform with thousands of courses and 1-on-1 access to experts

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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session






Get in touch

(315) 632-0735,
(315) 750-4379