GMP Data Integrity Best Practices and Regulatory Expectations for the Pharmaceutical Industry Including a Review of the New 2018 MHRA Data Integrity Definitions & Guidances and the FDA’s Most Recent Draft Guidance
Live, Interactive Training Webinar
Date: Thursday November 7, 2019
Time: 10:30am - 12:30pm ET (New York Time)
Instructor: Peter Calcott Ph.D. Biography>>>
Date: Thursday November 7, 2019
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. Recently 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 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 released in January 2015. The FDA approach has been less direct but still forceful with them issuing a Guidance in early 2016. 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.
-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 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 sets of regulations. Below are citations from ICH and examples of regulations that are applicable to data integrity process and philosophy:
- 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|
|10:40 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,|
|11:40 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,|
|12:30 PM||Live 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 participation for attendee training records
Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:
- Senior management
- Quality Assurance personnel and management
- Quality Control personnel and management
- Compliance auditors and management
- Process development scientists and management
- Supply Chain and Logistics managers
- Regulatory Affairs Professionals
- Engineering staff and management
- IT management and staff working in regulated areas
Instructor: Peter Calcott Ph.D.
Peter H. Calcott, Ph.D. is President, Calcott Consulting which is focused on delivering solutions to pharmaceutical and biotechnology companies in the areas of corporate strategy, supply chain, quality, clinical development, regulatory affairs, corporate compliance and enterprise e-solutions. He is also an Academic Program Developer for the University of California, Berkeley’s Biotechnology and Pharmaceutics Postgraduate Programs. Prior to this he was VP at the executive team level at PDL BioPharma where he was responsible for development and implementation of Quality & Compliance strategy across the corporation… Full Bio>>>
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