Data integrity is the cornerstone of your operations and the trusting relationship you have with your customers – the agencies and patients. This is true in the development cycle and submissions as well as in the manufacturing phases of the product lifecycle. Lapses in data integrity can hit any corporation and can be as simple as miscalculations all the way to fabrication of data, unintentional to intentional. Are you vulnerable? And do you really know if you are? Some serious failures have plagued manufacturers with FDA issuing warning letters. The Europeans have also detected the same data integrity issues as well and reported on them. New guidances have been issued from these agencies on the topic to advise us. In 2015, MHRA issued a comprehensive Guidance on the topic followed by another in 2016 to broaden the topic. In 2018, MHRA finally issued the full complete Guidance, in April 2016, FDA has also issued their own a guidance to help us. In addition, the WHO and PIC/S have also issued guidances in 2016.

In this live interactive training webinar, we will examine the issues surrounding data integrity lapses. We will examine the types, how to detect them, how to determine the root causes of these failures. Intentional and unintentional failures point to different root causes which then lead to different solutions. We will examine how the Europeans have taken the issue seriously and are meeting the challenge face on by reviewing the new MHRA GMP Data Integrity Definitions and Guidance. The MHRA broadened the topic with their 2018 Guidance to include GXP. The tools described will aid you in detecting, measuring, investigating and remedying the failures leading you to regaining the trust of your customers.

Learning Benefits:

• MHRA GMP data integrity definitions and guidances are explained.
• FDA data integrity guidance definitions and principles are described.
• How to examine your supply chain and development programs with the use of Quality Risk Management to identify where the risk of data integrity lapses are present.
• The tell-tale signs that you have data integrity problems.
• To tell the difference between intentional and unintentional failures of data integrity.
• How to develop a remediation plan to decrease risk to an acceptable level in your operations.
• How to be proactive in areas the FDA focused on and by learning from the Europeans and being ahead of the game.
• How regulatory agencies detect data integrity problems.
• Understanding how MHRA vs the FDA are tackling the issues.
• How to integrate the FDA and MHRA approaches into your data integrity program.

Regulations that will be Covered:

Each country has its own specific set of regulations. Below are examples of regulations that are applicable:

• EMEA Eudralex Volumes 1, 2, 3, 4, 9 for Drugs and Biologics in EU.
• Code of Federal Regulations 21 sections 210, 211 for Biological Products and Drugs and 600 series for Biologicals in addition for USA.
• MHRA GMP Data Integrity Definitions and Guidance for Industry released in March 2015.
• MHRA GXP data integrity guidance of 2018.
• FDA Data Integrity and Compliance with CGMP Guidance released in April 2016.
• EMA data integrity guidance 2016.
• WHO data integrity guidance 2016.
• PIC/S data integrity guidance 2016.
• International Conference on Harmonisation Quality Series with an emphasis on ICH Q9.

Webinar outline and time breakdown:

Time*

10:15 AM Log-In Period

10:30 AM Introduction

10:40 AM What is data integrity?
The impact of data integrity issues,
Where can data integrity failures happen?
How to know when it happens,
Intentional and unintentional types of failure,

11:30 AM 10 Minute Break

11:40 AM How to get to the root cause of data integrity failures,
The long slow route to repairing the damage of failures,
What the EU is saying via the MHRA guidance,
FDA approach to data integrity problems,
Warning letters tell you how it is detected by the FDA,
How to prevent data integrity failures from happening,
Conclusions,

12:30 PMLive Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

• A copy of the presentation slides
• A certificate of training for attendee training records

Who should attend:

The following individuals or disciplines will benefit from attending this Webinar:

• Quality Assurance Personnel
• Quality Control Personnel
• Supply Chain and Logistics Managers
• Regulatory Affairs Professionals
• Process Development Scientists and Management
• IT Management
• Senior Management
• Engineering Staff and Management
• Project Managers working in the CMC arena

How to Attend:
All Pharma Webinars live training programs audio and visuals are delivered via Cisco WebEx with a basic system requirement of a computer with internet access. You do not require a Webex account to join Pharma Webinars’ live training courses, participants receive an email invitation that provides the access you need to join the meeting.